Approved Clinical Trials This page provides a searchable list of all clinical trial research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology (UNCST).
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Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
Bruce Kirenga J
ID: UNCST-2019-R001460
 SAFETY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF HERBAL PRODUCTS FOR THE TREATMENT OF ACUTE RESPIRATORY VIRAL INFECTIONS INCLUDING SARS-COV2 IN UGANDA; PHASE 2A OPEN LABEL CLINICAL TRIAL
REFNo: HS2548ES

The general objective is to assess the safety, pharmacokinetics and preliminary efficacy of TazCoV and Vidicine for the treatment of acute respiratory viral infections (SARS-CoV2, RSV and Influenza A/B) in Uganda.
Specific objectives
1. To determine the safety and pharmacokinetics of TAZCOV and Vidicine herbal products among adult patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza A/B

2. To determine the extent of SARS-CoV2, RSV and Influenza A/B viral clearance among adult patients with acute viral respiratory infection treated using TAZCOV and Vidicine

3. To establish time-to-remission of symptoms among patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine

4. To evaluate disease progression among patients with acute respiratory infections due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine
 Kampala, Mulago
 Uganda 2022-11-29 12:38:24 2025-11-29 510 The maximum individual participant trial duration will be 90. The actual time the trial will last will depend on the rate of enrollment. It is estimated that the trial will take 18 months. days. The Government of Uganda through the Ministry of Science, Technology and Innovation-Office of the President (STI-OP) Medical and Health Sciences Clinical Trial Non-degree Award
Bonny Aloka
ID: UNCST-2022-R010624
 Development and Evaluation of Nutrient-Dense Composite from Local Food Materials to Manage Moderate Acute Malnutrition (MAM) and Nodding Syndrome in northern Uganda
REFNo: A234ES

3. To investigate the stakeholder perception regarding the nutrient dense composites developed to manage MAM and NS in Acholi and Lango sub-regions,To evaluate the efficacy of the recipes in improving the conditions of clients with MAM and nodding syndrome in Acholi and Lango sub-regions,To test the level of acceptability of the developed composites by the selected mothers/care takers and their children in Acholi and Lango sub-regions,To develop a nutrient dense composites from local food materials to manage MAM and nodding syndrome in Lango and Acholi sub-regions,To develop a nutrient dense composite from local food materials to manage moderate acute malnutrition (MAM) and nodding syndrome in Lango and Acholi sub-regions in northern Uganda.,
 Lira, Ayami Parish
Alebtong, Ayami Parish
Kole, Akwirididi Parish
Oyam, Atura Parish
Gulu, Pawel Parish
Nwoya, Kalatocon Parish
Pader, Kalawinya Parish
Kitgum, Pajimu Parish
 Uganda 2022-11-28 11:12:34 2025-11-28 387 The study population will be children between 6-23 months (MAM), Children aged 3-28 years (nodding syndrome) and adults aged 18-80 years of age (sensory evaluation). European Union Agricultural Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 Ring vaccination trial to evaluate the efficacy and safety of Sudan ebolavirus vaccines in Uganda
REFNo: HS2574ES

Probable SUVD and death from confirmed SUVD ,main secondary objective is to assess the safety of the vaccine by monitoring weekly for 21 days any adverse reactions to vaccination and any other serious adverse events,The primary analysis will be of laboratory-confirmed SUVD (from samples taken either while living, or within 48 hours of death),
 Uganda 2022-11-23 15:04:05 2025-11-23 N/A All active contacts of Ebola viral disease, Participants aged 6 years and above, all tribes, all genders World Health Organisation and the Ministry of Health Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Haruna Muwonge
ID: UNCST-2019-R000128
 EFFICACY AND SAFETY OF DIHYDROARTEMISININ-PIPERAQUINE (EURARTESIM) FOR TREATMENT OF UNCOMPLICATED P. FALCIPARUM MALARIA IN ADULT PATIENTS WITH COVID-19 CO-INFECTION: AN OPEN LABEL RANDOMISED PILOT CLINICAL TRIAL (EMCOS CLINICAL TRIAL)
REFNo: HS2563ES

To evaluate the incidence of adverse events in adult participants with uncomplicated P. falciparum malaria and COVID-19 coinfection receiving DHA/PPQ treatment or Artemether – lumefantrine treatment. ,To determine the efficacy of DHA-PPQ in treatment of adult patients suffering from uncomplicated P. falciparum malaria with COVID-19 coinfection.,To assess the therapeutic efficacy and safety of DHA-PPQ for the treatment of uncomplicated P. falciparum malaria- COVID-19 co-infection.
 Kampala, all parishes
Wakiso, all parishes
 Uganda 2022-11-17 18:12:26 2025-11-17 80 Adults of 18 years and above diagnosed with COVID-19 RT-PCR of SARS-CoV-2 plus a positive P. falciparum malaria parasite blood slide at Mulago National Referral Hospital, Kiruddu Hospital, and Entebbe regional referral Hospital. The study will include participants who are 18 years or more living around the areas of Kampala City, Wakiso District and Mukono District and who consent in writing to participate in the study. Alfasigma S.p.A. (Makerere University Lung Institute is CRO) Medical and Health Sciences Clinical Trial Non-degree Award
Proscovia Nabunya
ID: UNCST-2019-R000970
 Suubi-Mhealth: A mobile health intervention to address depression and improve ART adherence among Youth living with HIV (YLHIV) in Uganda
REFNo: SS1442ES

The overall goal of this proposal is to develop a mobile health intervention (hereafter “Suubi-Mhealth”) for use among Ugandan youth with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention (mobile app) will apply user-centered design methodologies and will be based on the cognitive-behavioral therapy (CBT) tenets found to improve depression among individuals with HIV.

The study will be conducted in two phases (R21 and R33) as specified below

Phase 1. R21 Aim 1: Develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand the needs of depressed YLHIV, ages 14-17. We will conduct four focus groups, each with 6-8 depressed YLHIV and two focus groups with health care providers, recruited from clinics across the greater Masaka region of Uganda for feedback on proposed intervention content and methods to increase participation and retention.

R21 Aim 2: Based on the results of Aim #1, we will explore the feasibility and acceptability of Suubi- Mhealth for use with depressed YLHIV on a small scale (N= 30) to inform subsequent refinement for the larger phase of this project (R33 phase).

Phase 2. R33 Aim 1: Pilot test the preliminary impact of Suubi-Mhealth versus a waitlist control group (to receive the intervention after the active treatment condition), on reducing depression (primary outcome) and improving ART adherence, mental health functioning, quality of life, and lowering HIV stigma (secondary outcomes).

R33 Aim 2: Qualitatively examine barriers and facilitators for integrating Suubi-Mhealth into health care settings for depressed YLHIV.

 Uganda 2022-11-15 3:42:47 2025-11-15 262 The target population for this study is YLHIV enrolled in care at a health clinic that has partnered with ICHAD and RTY in the study region. We will recruit depressed YLHIV between ages 14-17, and health providers who agree to participate in the study at the participating clinics. We will enroll youth who are at least 14 so that our entire sample “should” be at a developmentally similar stage and because at age 14, adolescents begin to exhibit symptoms of depression that become more prevalent by age. Youth inclusion criteria: 1) Ages 14-17 years with the cognitive ability to understand and comprehend the assenting process, 2) HIV positive and aware of their status i.e., disclosed to, 3) receiving ART and care from one of the participating clinics, 4) and living within a family, including with extended family members (not in institutions). We will identify youth with depression symptoms by administering the Patient Health Questionnaire (PHQ-9), which has been validated in rural settings in Uganda. Youth will be enrolled in the study after ascertaining their score on the PHQ-9. Exclusion criteria: Youth will be ineligible if: 1) they do not meet the inclusion criteria; 2) they are unable to understand the study procedures and or participant rights during the informed consent process or they are unwilling or unable to commit to completing the study. If the youth or adult caregivers presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation. Inclusion criteria for health care providers. Providers will be identified and recruited from collaborating clinics if they are working directly with YLHIV and agree to participate in the study. Inclusion criteria for clinics. Clinics registered and supported by the Government of Uganda to provide ART to adolescents and YLHIV in the greater Masaka region, and have adolescent-friendly services e.g., adolescent clinic days. National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 Suubi+Adherence4Youth: Optimizing the Suubi Intervention for Adherence to HIV Treatment for Youth Living with HIV in Uganda
REFNo: SS1449ES

The proposed Suubi+Adherence4Youth study seeks to unpack the Suubi intervention to identify the most impactful and sustainable components: economic vs. psychosocial components, for adolescents living with HIV (ALHIV) across the HIV care continuum. The Suubi intervention was tested as a package of four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) a manualized and visual-based intervention for ART adherence and stigma reduction; and 4) Engagement with HIV treatment-experienced role models. We propose a factorial experiment to unpack and optimize the Suubi intervention to enhance scale up in health systems using the multi-phase optimization strategy (MOST) -an engineering-inspired intervention framework. Our ultimate goal is to build Suubi version 2.0 that meaningfully improves viral suppression while performing efficiently, affordably, and at scale for a sustained impact.

Aim 1. Conduct a factorial experiment (optimization trial) to test the main effects of each of the four Suubi intervention components and combinations of components (interactions) on viral suppression (primary outcome).

Aim 2. Test mediators and explore moderators that explain and modify the relationship between each of the four Suubi intervention components and viral suppression.

Aim 3. Compare the cost and cost-effectiveness of each of the four Suubi intervention components and every combination of components.

 Masaka, Kimaanya
Rakai, Kakuuto
Kyotera, Kyotera TC
Lwengo, Lwengo
Kalungu, Bukulula
 Uganda 2022-11-11 17:11:59 2025-11-11 576 We will recruit 576 ALHIV between ages 11-17, from 48 healthcare clinics associated with ICHAD and Masaka Catholic Diocese. Inclusion and Exclusion Criteria: 1) An adolescent living with HIV (confirmed by medical report and aware of status); 2) living within a family; 3) being 11–17 years of age (at enrollment); 4) Prescribed ART; and 5) enrolled in ART care at one of the 48 health clinics in the study districts. Exclusion criteria: Adolescents will be ineligible if: 1) they are unable to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent parent. 2) If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
Namulema Edith
ID:
Feasibility of using Continuous Positive Airway Pressure via the ‘LeVe CPAP System’ among Children with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A mixed methods study
REFNo: HS2478ES

1) To assess the acceptability of the LeVe CPAP system to deliver continuous positive airway pressure among children with acute hypoxemic respiratory failure at Mengo Hospital Uganda.
2) To assess the safety of LeVe CPAP system among children with acute hypoxemic respiratory failure at Mengo Hospital Uganda.

Kampala, 1
 Uganda 2022-11-09 13:49:10 2025-11-09 40 Paediatric patients of Age > 1 month with hypoxemic respiratory failure and caretakers admitted at the paediatric ward. Leeds University Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Orem
ID: UNCST-2021-R012016
 A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals with Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA)
REFNo: HS2367ES

To evaluate if changes in serum cytokine levels correlate with clinical response.,To assess the effect of pomalidomide treatment on serum cytokine levels.,To evaluate the effects of pomalidomide monotherapy on standard measures of HIV control, i.e., CD4 counts and HIV viral loads, in this participant population.,To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy to justify its further development for HIV-associated KS in sub-Saharan Africa and is safe and tolerable.,
 Adjumani, fill this
Kampala, Mulago
Kampala, Mulago
 Uganda 2022-11-08 13:27:55 2025-11-08 12 The study will recruit participants with AIDS-associated Kaposi Sarcoma in Uganda who are 18 years and above. Both sexes are eligible to participate in the study. AIDS Malignancy Consortium Medical and Health Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 Efficacy, Safety and Effectiveness of Injectable Cabotegravir/Rilpivirine in Improving HIV Control in Sub-Saharan Africa: A pragmatic Phase 3 Open-label Randomized Controlled Trial.
REFNo: HS2475ES

Primary objective:
To demonstrate the non-inferior efficacy of switching to every 2 months (Q2M) intramuscular (IM) injection of cabotegravir (CAB) long acting (LA) plus rilpivirine (RPV) LA compared with continuation of first-line oral ART over 12 months in people living with HIV (PLHIV) with a history of, or at risk of, sub-optimal HIV control.

Secondary objectives:
1) To demonstrate the antiviral activity and the impact on retention in HIV care of switching to Q2M CAB LA + RPV LA compared with continuation of oral ART over 12 and 24 months in PLHIV with a history of, or at risk of, sub-optimal ART adherence or engagement in care.

2) To demonstrate the immunological activity of switching to Q2M CAB LA + RPV LA compared with continuation of oral ART over 12 and 24 months in PLHIV with a history of, or at risk of, sub-optimal ART adherence or engagement in care. This will be measured through change in CD4+ T cell count and incidence of HIV disease progression.

3) To evaluate the safety and tolerability of switching to Q2M CAB LA + RPV LA compared to continuation of oral ART.

4) To assess genotypic viral resistance in participants experiencing protocol-defined confirmed virological failure (plasma HIV-1 RNA >200 c/ml) and its impact on future treatment options including proportion who resuppress on dolutegravir.

5) To evaluate the effect of Q2M CAB LA + RPV LA on health-related quality of live, treatment satisfaction and treatment adherence. To describe cost-effectiveness and acceptability of the regimen.

Kampala, NOT APPLICABLE
Wakiso, Entebbe
Western Region, Fort Portal
 Uganda 2022-11-02 17:27:11 2025-11-02 540 Age: Adults 18 years and above Gender: Any Source: HIV clinics in Uganda (MRC/UVRI & LSHTM Entebbe, Infectious Diseases Institute Kampala, Joint Clinical Research Centre clinics in Fort Portal and Lubowa) Method of recruitment: Pre-screening of clinic database to identify potentially eligible participants who are counselled about the study and invited to be screened. Only adults who are eligible after the screening period are randomized. London School of Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Hannah Kibuuka
ID: UNCST-2020-R014355
 A randomized, double-blind, positive-controlled Phase III clinical trial to evaluate the efficacy and safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in population previously unvaccinated with COVID-19 vaccine and aged ≥18 years
REFNo: HS2508ES

To evaluate the protective efficacy of SCTV01E against symptomatic COVID-19 occurring from 14 days after the 2nd dose in population
previously unvaccinated with COVID-19 vaccine.


To evaluate the protective efficacy of SCTV01E against symptomatic COVID-19 occurring from 7 days after the 3rd dose in population previously unvaccinated with COVID-19 vaccine
 Kampala, Nakasero
Wakiso, Central
 Uganda 2022-10-28 15:05:42 2025-10-28 2000 Individuals previously unvaccinated with COVID-19 vaccine and aged ≥18 years Sinocelltech Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Clovice Kankya
ID: UNCST-2020-R010154
 Capacitating One Health in Eastern and Southern Africa (COHESA)
REFNo: SS1482ES

To understand One Health performance, capacity, and bottlenecks within Uganda,To understand Current One Health Research and Innovation within Uganda,To understand One Health challenges, gaps and capacities within Uganda,
 Uganda 2022-10-27 9:26:54 2025-10-27 15 Key Informant Interviews, 15 people per workshop. Individuals and organizations contributing to One Health in both public and private sectors across Uganda. European Union Social Science and Humanities Clinical Trial Non-degree Award
Kamya Moses
ID: UNCST-2020-R014203
 Extension of SEARCH SAPPHIRE Dynamic Choice Prevention Study
REFNo: HS2447ES

To compare biomedical prevention coverage achieved using a Dynamic prevention model that includes a patient-centered CAB-LA delivery intervention to biomedical prevention coverage under the standard of care over 48 weeks.

Secondary Objectives: To determine the reach, effectiveness, adoption, implementation and maintenance of a patient-centered CAB-LA program embedded in 3 ongoing trials in the setting of antenatal clinic, outpatient clinic, and community.

Tertiary Objectives: To evaluate change in knowledge, awareness and acceptability/satisfaction at the staff and provider level with CAB-LA before and after provider and staff training and education in CAB-LA with patient-centered delivery model.


 Bushenyi, All parishes
Mbarara, All parishes
Ntungamo, All parishes
Sheema, All parishes
Mbarara, All parishes
 Uganda 2022-10-25 15:31:11 2025-10-25 350 The persons eligible for participation in the extension are those who were enrolled in the 3 ongoing DCP trials. Persons for the ANC study are recruited and enrolled through offering study participation at ANC clinics at government sponsored health facilities. Persons for the Outpatient department are recruited and enrolled through offering study participation at Outpatient department clinics at government sponsored health facilities. Persons for the community study are recruited via home visits by village health teams/community health workers. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Angelina Kakooza-Mwesige
ID: UNCST-2020-R014529
 Epilepsy in Uganda: Clinical characterization and co-morbidities, their relation to stigma among adolescents and impact of a community-based engagement program. (AWE Change project) REF: TASO-2022-102
REFNo: HS2421ES

1.TO CLINICALLY CHARACTERIZE EPILEPSY AND ITS IMPACTS AMONG CHILDREN AND ADULT CASES IN UGANDA. 2.DESCRIBE THE MAGNITUDE, DRIVERS, AND IMPACT OF EPILEPSY-RELATED STIGMA ON ADOLESCENTS IN UGANDA. 3.TO CO-CREATE AND EVALUATE THE IMPACT OF A COMMUNITY-BASED ENGAGEMENT PROGRAM TO REDUCE STIGMA ON EPILEPSY AMONG ADOLESCENTS IN UGANDA.
 Central Region,
Eastern Region,
Northern Region,
Western Region,
Butambala,
Bukomansimbi,
Buikwe,
Buvuma,
Gomba,
Kalangala,
Kayunga,
Kampala,
Kyankwanzi,
Kyotera,
Kalungu,
Luweero,
Lwengo,
Masaka,
Mpigi,
Mityana,
Mubende,
Mukono,
Nakasongola,
Nakaseke,
Rakai,
Sembabule,
Lyantonde,
Wakiso,
Amuria,
Bududa,
Bugiri,
Bukedea,
Bududa,
Bududa,
Bulambuli,
Busia,
Butaleja,
Bukwa,
Buyende,
Iganga,
Jinja,
Kaberamaido,
Kaliro,
Katakwi,
Kamuli,
Kibuku,
Kumi,
Luuka,
Manafwa,
Mayuge,
Mbale,
Namayingo,
Namutumba,
Ngora,
Pallisa,
Serere,
Sironko,
Soroti,
Tororo,
Abim,
Adjumani,
Agago,
Amuru,
Apac,
Arua,
Dokolo,
Kaabong,
Kitgum,
Koboko,
Kole,
Kotido,
Lamwo,
Lira,
Maracha,
Moroto,
Moyo,
Nebbi,
Nwoya,
Otuke,
Oyam,
Pader,
Yumbe,
Zombo,
Buhweju,
Buliisa,
Bundibugyo,
Hoima,
Ibanda,
Isingiro,
Kabale,
Kabarole,
Kamwenge,
Kanungu,
Kasese,
Kibaale,
Kiruhura,
Kiryandongo,
Kisoro,
Kyegegwa,
Kyenjojo,
Masindi,
Mbarara,
Mitooma,
Ntungamo,
Rubirizi,
Rukungiri,
Sheema,
Uganda 2022-10-25 14:54:28 2025-10-25 490 All ages across the life span, of every gender and tribe National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Fredrick Kabi
ID:
EVALUATION OF THE SAFETY, EFFICACY AND EFFECTIVENESS OF THE SUBOLESIN BASED ANTI-TICK VACCINE: A RANDOMISED DOUBLE BLINDED MULTI-SITE CONFINED FIELD TRIAL
REFNo: A191ES

OVERALL OBJECTIVE
Evaluation of the Safety, Efficacy and Effectiveness of Subolesin based Anti-tick Vaccine for control of ticks naturally infesting different cattle breeds under confined field conditions in Uganda.

SPECIFIC OBJECTIVES
I. To determine the safety of the injectable Subolesin based Anti-tick vaccine for control of tick infestations under natural confined field conditions.
II. To determine the efficacy of the injectable Subolesin based Anti-tick vaccine for control of tick infestations under natural confined field conditions.
III. To determine the effectiveness of the injectable Subolesin based Anti-tick vaccine for control of tick infestations under natural confined field conditions.

 Apac,
Mbarara,
Ibanda,
Mbarara,
Masindi,
Wakiso,
Uganda 2022-10-21 12:58:12 2025-10-21 360 1. Species: Bos indicus (Indicine) and Bos taurus (Taurine) cattle 2. Breed: All cattle breeds in the trial site 3. Ownership: Owned by NARO and UPS 4. Number: Each trial site will provide 72 head of cattle. Total number of experimental cattle will b Government of Uganda (GoU) Agricultural Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-MTM in African children living with HIV.
REFNo: HS2496ES

Primary objective a) To assess the safety and reactogenicity profile of the malaria vaccine candidate R21/Matrix-MTM in 5-36-month-old African children living with HIV Secondary objectives a) To assess the humoral immunogenicity of R21/Matrix- MTM in 5-36-month-old African children, comparing children living with HIV with HIV negative children b) To assess the impact of vaccination on HIV reservoir c) To assess whether increasing age and nadir CD4 count are associated with immunogenicity of R21/Matrix-MTM in 5-36- month-old African children living with HIV Tertiary objectives a) To assess the immunogenicity profile of R21/Matrix-MTM in 5- 36-month-old African children, comparing children living with HIV with HIV negative children
 Wakiso, Central
 Uganda 2022-10-20 18:13:49 2025-10-20 120 120 Children aged 5-36 months will be recruited to the trial. HIV positive children will be recruited from Pediatric HIV care centers within Kampala and Wakiso districts while HIV negative children will be recruited from Entebbe hospital and primary health care centers that provide immunisation and growth monitoring services within Kampala and Wakiso districts. 100 children with confirmed HIV infection will be recruited to group 1 and 20 children without HIV will be recruited to group 2. The Serum Institute of India Pvt Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Robert Kalyesubula
ID:
Human-centered design to adapt and inform an integrated chronic disease management program in Uganda using mobile payment services. (Acronym: IMPEDE CVD)
REFNo: HS2445ES

1)To understand patient and provider perspectives on the potential and acceptability of financing schemes and mHealth interventions aimed at strengthening behavior in relation to ideal drug availability and uptake among NCD patients (Work Package (WP) 1a).
2)To develop together with end-users a prototype for a mobile phone-based solution (including mobile-based nudges) to increase the availability and uptake of NCD drugs (WPs 1b, and 2).
3)To test the prototype, establishing proof of concept, and to assess end-users’ experiences interacting with two versions of the prototype (comparing two saving models), including how users make and evaluate payment management decisions, in preparation for a subsequent study (WP 3).
 Nakaseke, Semuto
Uganda 2022-10-20 18:01:35 2025-10-20 For the quantitative Studies, interview will be conducted until saturation; For the quantitative study (Trial), 380 participants will be included in the study The respondent groups for this study include medical health care providers (CHWs, medical doctors, clinic staff throughout all work packages), community members and key stakeholders (religious and local leaders, members of pooled financing schemes, academics (WP1 and 2)), clients (adults aged 18 years or older who regularly seek care in the study facility for diagnosed hypertension and diabetes (WP1-3), and decision makers (policymakers, MoH representatives, Health insurance (WP1)), as their attitudes, experiences, knowledge, and behaviors are explicitly within the target of the research question. For WP3, we also include study team members involved in intervention design, implementation, and evaluation processes as respondents. This study is funded through the German Alliance of Global Health Research. Medical and Health Sciences Clinical Trial Non-degree Award
Francis Kiweewa
ID: UNCST-2020-R014929
 A Global Multi-Center, Randomized, Blinded, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older
REFNo: HS2476ES

The objective of this study is to evaluate the effectiveness, safety, and the ability of the study vaccine to provoke an immune response in your body against COVID-19. This study is necessary because the COVID-19 epidemic poses a significant global health challenge, and a large number of effective vaccines are still needed for the future. A total of approximately 34,000 participants like you from around the world, such as Africa and Asia will participate in this study. The entire study will last approximately 20 months, and your participation will last approximately at least 17 months. (The exact duration of your participation in the study may depend on the specific situation of the study. Please consult your study doctor at that time.)
 Wakiso,
Kampala,
Lira,
Tororo,
Uganda 2022-09-28 14:10:52 2025-09-28 234 Adults aged 18 years and older of all sexes. AIM Vaccine Co., Ltd, AIM Innovation Biotechnology (Shanghai) Co., Ltd, LiveRNA Therapeutics Inc. & Ningbo Rongan Biological Pharmaceutical Co., Ltd Medical and Health Sciences Clinical Trial Non-degree Award
Byamah Mutamba Brian
ID: UNCST-2022-R011124
 Strengthening Care in collaborAtion with People with lived Experience of psychosis in Uganda (SCAPE-U
REFNo: HS2327ES

General objective
To assess the impact of SCAPE-U on individual, family members’ and health system outcomes, and evaluate trial procedures to determine the optimal design for a future fully-powered cluster randomised controlled trial (RCT).
Specific objectives
1. To assess the feasibility and acceptability of SCAPE-U from the perspective of people with lived experience of psychosis, their family members and primary and community care providers.
2. To demonstrate proof-of-concept for the benefit of SCAPE-U for service users (i.e., patients with psychosis receiving primary care services) and their families, including changes in psychosis symptoms, quality of life, frequency of hospitalization and the potential impacts on family members.
3. To determine changes in health systems outcomes in terms of primary care provider knowledge, attitudes, competency in psychosis diagnosis and management, as well as accuracy of diagnosis and fidelity to treatment guidelines in actual care settings.
4. To evaluate trial procedures, including costing, recruitment and retention, and data collection protocols, to determine the optimal design for a future fully-powered cluster RCT

 Kampala, All parishes
Wakiso, All parishes
 Uganda 2022-09-21 21:32:50 2025-09-21 120 persons diagnosed with Psychosis There will be five categories of participants in this study: Persons with lived experience of psychosis (SCAPE-U facilitators) – Approximately 10-20 people with lived experience of psychosis will be recruited from prior YouBelong Uganda programs to be trained in PhotoVoice as SCAPE-U facilitators in the SCAPE-U arm. These people with lived experience of psychosis will require a diagnosis of a psychotic disorder confirmed by a mental health professional (psychiatric clinical officer or psychiatrist). Mental health professionals will be required to evaluate PLWP for any health or functional impairment that could jeopardize their safe participation as well as seek their consent. Currently participating in treatment (taking antipsychotics, receiving psychosocial support, or both) is not an exclusion criterion. We plan to draw SCAPE-U facilitators from YouBelongHome beneficiaries. The YBH intervention comprises two unique phases: 1) a pre-discharge assessment which provides a detailed description of an individual’s general health and mental health history; individual goals and aspirations; a social demography of the individual and his/her family with particular emphasis on potential barriers to and supports for individual and family well-being; and the education and awareness level of the local community in mental health; this first phase is completed in a 2 to 3 weeks and 2) the second phase is the post-discharge community-based strengthening, informed by the pre-discharge assessment, that focuses on both empowering the family as an active agent in the returned person’s recovery and connecting the person with SMI and family to the support of friends, extended family, community, and work. This phase includes both face to face and phone engagements over a 12-week period. In response to the COVID-19 pandemic, YBU has modified the pre and post discharge process from a 16 week to a 5-week intervention, to allow for a higher rate of return and resettlement of patients, while ensuring that those patients in need of complex mental health and psychosocial care still receive the unmodified YBH pre and post discharge version of care. They will meet the following selection criteria: a) completion of the YBH program, b) confirmed diagnosis of a primary psychotic disorder (e.g., schizophrenia) by a psychiatrist or PCO, c) provision of informed consent, d) fluency in the local language (Luganda), e) good functioning with respect to performance of daily chores, engagement with family members, comprehension and community participation as assessed by the YBH team, and f) a supportive family member. We will also maintain professional conduct guidelines to monitor experience of clients during home visits and other interactions. Primary care providers – Primary care providers who have been selected by the in-charge of the health facility to participate in the study, will be trained in mental health service delivery with the mhGAP-IG. Two providers will be selected per facility and there are no exclusion criteria, for an estimated 70 primary care providers per arm. At the primary care provider level, all primary care providers being trained in mental health services will be eligible for participation. Community health workers – Five community health workers (VHTs) who are affiliated to the health facilities where PHWs receive training in mhGAP and have been selected by the in-charge of the health facility to participate in the study. Service users (main intended beneficiaries) – The primary intended beneficiaries of study interventions are patients receiving treatment for psychoses. At the patient level, any patient presenting to HC-II, III, or IV receiving a diagnosis of psychosis from primary care providers will be eligible for participation in this study. The goal is to have 60 patients per arm for the two arms (120 patients total). At the patient level, any patient presenting to HC-II, III, or IV receiving a diagnosis of psychosis from primary care providers will be eligible for participation in this study. Service user inclusion criteria: 1. Persons diagnosed with psychosis at a primary health care facility in Kampala/Wakiso District; 2. Ability of the patient or responsible surrogate to consent to study enrolment and procedures; 3. Persons eligible for outpatient management of psychosis. Exclusion criteria will be 1. Persons diagnosed with psychosis requiring inpatient management/services; and 2. Persons for whom consent for participation in the study cannot be obtained. Family members of service users – At least one primary carer to a participating service user will be identified in order to collect outcome data from the carer Wellcome Trust, UK Medical and Health Sciences Clinical Trial Non-degree Award
Henry Ssenyondo
ID:
Maternal Antibody in Milk After Group B Streptococcus Vaccination in Uganda: MAMA study
REFNo: HS1986ES

General Objective • To determine the concentration of antibody transferred in breastmilk following vaccination with Group B Streptococcal vaccine Specific Objectives • To determine the anti-GBS (anti-Alp1N, Alp2N, AlpCN and RibN) Immunoglobulin A (IgA) concentrations in the colostrum of women following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the total IgA and Immunoglobulin G (IgG) concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgA concentrations in the breastmilk of women at 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgG concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
 Kampala, Kawempe Central
 Uganda 2022-09-21 21:13:49 2025-09-21 50 Women 18 to 40 years All tribes Makerere University Medical and Health Sciences Clinical Trial Degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
 A phase Ib study to assess the safety and immunogenicity of a recombinant adenovirus-based vaccine against plague in Uganda
REFNo: HS2387ES

Primary To investigate safety and tolerability of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine in healthy African adults aged 18 to 49 residing in Uganda, when given as one or two dose(s) intramuscularly with different prime-boost intervals Secondary To determine the immunogenicity of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine, in healthy African adults aged 18 to 49 years residing in Uganda when given as one or two dose(s) intramuscularly with different prime-boost intervals. Tertiary Exploratory immunogenicity assays to determine the immunogenicity of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine, in healthy African adults aged 18 to 49 years residing in Uganda when given as one or two dose(s) intramuscularly with different prime-boost intervals.
Masaka, KATWE
 Uganda 2022-09-12 18:28:42 2025-09-12 36 Healthy male or female African adults aged 18-49 years, inclusive. Inclusion and exclusion criteria are as follows: Inclusion Criteria • Willing and able to give informed consent for participation in the trial. • Male or female aged between 18-49 years inclusive at enrolment (first vaccination visit, V1) • In good health as determined by o Medical history (as determined by verbal medical history) o Physical examination o Clinical judgment of the investigators • Female participants of childbearing potential must be willing to ensure that they use effective contraception during the trial and for 3 months after the last vaccination. • Female participants of childbearing potential must have a negative pregnancy test on the day(s) of screening and vaccination. • Able to attend the scheduled visits and to comply with all study procedures • Agrees to refrain from donating blood for the duration of the trial • Clinically acceptable baseline screening results (includes vital signs, physical examination, urinalysis, and laboratory results) • In the Investigator’s opinion, is able and willing to comply with all trial requirements. Exclusion Criteria The participant may not be enrolled in the study if any of the following apply: • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. • History of significant organ/system disease that could interfere with trial conduct or completion. This includes a known history of significant disease in the following: o Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death o Respiratory disease such as uncontrolled asthma and chronic obstructive pulmonary disease o Endocrine disorders such as diabetes mellitus and Addison’s disease o Significant renal or bladder disease o Biliary tract disease o Gastro-intestinal disease such as inflammatory bowel disease, major abdominal surgery within the last two years, coeliac disease and liver disease (including hepatitis B or C infection) o Neurological disease such as seizures and myasthenia gravis o Haematological problems such as coagulation problems or anaemia (haemoglobin < 12.5g/dL for females and < 13.5 g/dL and for males) o Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency o Psychiatric illness requiring hospitalisation or depression if severity is deemed clinically significant by the study Investigators o Known or suspected drug and/or alcohol misuse o Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ • Any other significant disease or disorder which, in the opinion of the Investigator, could: o Put the participant at risk because of participation in the trial o Influence the result of the trial o Impair the participant’s ability to participate in the trial • History of allergy to a vaccine or any component of the vaccines used in this study • History of anaphylaxis • Have any known or suspected impairment or alteration of immune function, resulting from, for example: o Congenital or acquired immunodeficiency o Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition o Autoimmune disease o Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy (including for more than 7 days consecutively within the previous 3 months). • Receipt of immunoglobulins or any blood product transfusion within 3 months prior to enrolment • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial • Weight <50kg or a body mass index (BMI) greater than 35kg/m2. • Known history of previous occurrence of disease caused by Y. pestis or receipt of a vaccine against plague • Current active participation in another research study involving an investigational product (including receipt of an IMP within last 30 days) or where involvement in this study could impact the results • It is not in the best interest of the volunteer to participate in the trial, in the opinion of the Investigator. University of Oxford Medical and Health Sciences Clinical Trial Non-degree Award
Gorretti Nassali
ID:
A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR?POSITIVE, HER2 NEGATIVE EARLY BREAST CANCER
REFNo: HS2133ES

Primary objective:
To demonstrate superiority of giredestrant over the control treatment
Secondary objectives:
1. To evaluate the efficacy of giredestrant compared with TPC
2. To evaluate the safety of giredestrant compared with TPC
3. To characterize giredestrant pharrmacokinetics (PK)
4. To evaluate health status utility scores of participants treated with giredestrant compared with TPC
5. To evaluate the efficacy of giredestrant compared with TPC
6. To evaluate the tolerability of giredestrant compared with TPC
7. To identify and/or evaluate biomarkers that are predictive of response to giredestrant
Kampala, mulago
 Uganda 2022-09-06 14:14:37 2025-09-06 Approximately 4700 participants will be screened to achieve random assignment in 1:1 ratio to study treatment of 4100 randomized participants for an estimated total of 2050 randomized participants per Approximately 4100 participants with medium- and high-risk Stage I?III histologically confirmed ER? and HER2? EBC will be enrolled during the global enrollment phase of this study. After completion of the global enrollment phase, additional participants F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel, Switzerland Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 ASSESSMENT OF USABILITY OF THE WONDFO HIV SELF-TEST ONE STEP HIV 1/2 WHOLE BLOOD/SERUM/PLASMA TEST BY UNTRAINED USERS
REFNo: HS1878ES

To evaluate the ability to correctly comprehend key messaging from device packaging and labelling, including the Instructions for Use.,The evaluation of untrained users’ and their interaction with the device in terms of effectiveness and efficiency, i.e. successful / unsuccessful completion and difficulty of the critical steps as per the Instructions for Use,To evaluate the ability of untrained users to obtain an accurate HIV test result using the Wondfo HIV Self-Test.,
 Buhweju, Nsika
Wakiso, Central
Bulambuli, Bulambuli Town Council
Mbale, Mbale City
 Uganda 2022-08-30 10:24:48 2025-08-30 100 All participants will be > 18 years old of all Sex from the bamasaba region Central Public Health Laboratories Medical and Health Sciences Clinical Trial Non-degree Award
Prudence Atukunda Friberg
ID: UNCST-2023-R006221
 The NutriMind Trial: A low-cost randomized trial combining a healthy diet and psychotherapy to treat depressive symptoms among university students – The case of Uganda
REFNo: HS2146ES

The primary outcome is a mean reduction of 6 scores on the CES-D scale
• Biomarkers of metabolism (i.e. lipids, carbohydrates and hormones) will be measured in samples from blood, urine or saliva as appropriate and using standard methods.
• Biomarkers of inflammation (e.g. CRP, interleukins) and antioxidants will be measured in blood, urine or saliva as appropriate and using e.g. multiplex-techniques, immunolabelling methods and metabolomics.
• Microbiome will be analysed in samples from the oral cavity and from feces using established techniques (16S rRNA amplicon sequencing and reduced metagenome sequencing).

The combined intervention arm with MBCT and Diet will reduce depressive symptoms more than the control arm
Biomarkers of metabolism ( lipids, carbohydrates and hormones) measured in samples from blood, urine or saliva as appropriate and using standard methods
Biomarkers of inflammation ( CRP, interleukins) and antioxidants measured in blood, urine or saliva as appropriate and using multiples-techniques, immunolabelling methods and metabolomics
Microbiome will be analysed in samples from the oral cavity and from feces using established techniques ( 16rRNA amplicon sequencing and reduced metagenome sequencing)
 Kampala, Makerere
 Uganda 2022-08-03 11:19:53 2025-08-03 200 The study population is university students with self reported depression symptoms as determined by Beck depression Inventory validated assessment tool. The partcipants will be aged range 19 and above both female and males will be included from all the tr University of Oslo Medical and Health Sciences Clinical Trial Non-degree Award
Atupele Mlangwa Subira
ID:
PREVALENCE AND FACTORS ASSOCIATED WITH PROLONGED HOSPITAL STAY FOLLOWING CAESEREAN DELIVERY AT MBARARA REGIONAL REFERRAL HOSPITAL
REFNo: NS383ES

2. To determine the factors associated with prolonged hospital stay following caesarean delivery at MRRH,1. To determine the prevalence of prolonged hospital, stay following caesarean delivery at MRRH,To determine the prevalence and factors associated with prolonged hospital stay following caesarean delivery at MRRH,
 Mbarara, Medical Cell
 Tanzania 2022-07-26 11:29:37 2025-07-26 427 Adult women delivered by caesarian section at Mbarara Regional Referral Hospital Atupele Subira Mlangwa Natural Sciences Clinical Trial Degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY
REFNo: HS2173ES

8. To validate the ability of fertility biomarkers to diagnose and predict permanent loss of ovarian function, and to determine the impact of anti-cancer therapy on hormone levels,7. To evaluate health status utility scores of patients treated with atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine,6. To identify and/or evaluate biomarkers that are predictive of response to atezolizumab and trastuzumab emtansine (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to atezolizumab and trastuzumab emtansine, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of atezolizumab and trastuzumab emtansine activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety,5. To evaluate the immune response to atezolizumab and trastuzumab emtansine,4. To characterize the PK profiles of atezolizumab and trastuzumab emtansine when given in combination,3. To evaluate the safety of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine,2. To evaluate the efficacy of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine in the PRO-evaluable analysis set,1. The secondary efficacy objective for this study is to evaluate the efficacy of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine in both the ITT population and PD-L1-positive population,The primary objective for this study is to evaluate the efficacy of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine in both the ITT population (all comers) and the PD-L1-positive population (defined as all patients from the ITT population with a centrally assessed PD-L1-positive status [i.e., PD-L1 status of IC1/2/3] at randomization),
 Kampala, Mulago
Uganda 2022-07-21 11:00:02 2025-07-21 30 This study will enrolling women with a primary diagnosis of HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease i Nixon Niyonzima Medical and Health Sciences Clinical Trial Non-degree Award
Moffat  Nyirenda Joha
ID: UNCST-2020-R019333
 Development and Evaluation of an Integrated Community-based Management Model for HIV, Diabetes, and Hypertension in Tanzania and Uganda (The INTE-COMM study)
REFNo: HS2278ES

To determine the effectiveness of community-based integrated management of HIV, diabetes, and hypertension in comparison to clinic-based integrated management of these conditions in terms of patient outcomes, acceptability, and potential cost-effectiveness.
 Kampala, N/A
Wakiso, N/A
Mpigi, N/A
Lwengo, N/A
 Malawi 2022-07-13 16:33:33 2025-07-13 1,736 participants Assuming an intra-class coefficient, rho of 0.02, we need to form 116 groups, each comprising 12 persons (8 with diabetes or hypertension and 4 with HIV). This will provide over 80% power to detect an absolute difference in risk of diabetes and hypertension control of 10% (i.e. 50% versus 60% achieving good control in the 2 arms would be statistically significant at the 5% two-sided significance level). Power will be very high for differences larger than this. For the HIV viral suppression endpoint, we assume that viral suppression is close to 90% and that the primary aim is to show non-inferiority with the community-care arm (and secondary analyses will compare superiority). The trial will have over 80% power to show non-inferiority with a margin of delta= 8.5%, 7.5%, and 5.5% assuming viral suppression is 85%, 90% and 95% respectively. To allow for losses to follow-up, our target for enrolment is 124 groups each comprising 14 participants (i.e. a total of 1,736 participants). National Institute of Health Research (NIHR) Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Mukonzo
ID: UNCST-2021-R013916
 Ivermectin-artemisinin Combination Therapy for Eradication of Malaria
REFNo: HS2081ES

Main Objective: 1. To investigate the effect of ivermectin adjunct therapy on household transmissibility of malaria from malaria-infected patients receiving artemether /lumefantrine Specific objectives 1. To determine the household malaria transmissibility within one month of IVN and artemether / lumefantrine therapy. 2. To determine the structural similarity of the nanopore plasmodium sequences between infecting plasmodium species isolated from the index patient and other household malaria positive patients. 3. To assess the safety of ivermectin-artemether/lumefantrine in malaria-infected patients.
 Kasese, NA
 Uganda 2022-07-13 16:29:55 2025-07-13 110 Participants Adults aged 18 to 65 years of age, both males and females. No specific tribe in our inclusion criteria but most of the study participants are expected to be Bakonzo given that the study site is Kasese. MAKERERE UNIVERSITY RESEARCH AND INNOVATION FUND Medical and Health Sciences Clinical Trial Non-degree Award
Andrew Mujugira
ID: UNCST-2019-R000871
 CHOICE-BASED PrEP DELIVERY FOR TRANSGENDER PEOPLE IN UGANDA
REFNo: HS2316ES

Aim 1: Identify PRECEDE factors that influence PrEP implementation for transgender people in Uganda.

Guided by the PRECEDE-PROCEED model, which is widely used for public health interventions, we will analyze previously collected qualitative data from four TGP studies and also conduct two new focus groups with TGP and providers to identify predisposing, reinforcing, and enabling factors that may impact implementation of choice-based PrEP. A stakeholder workshop anchored in good participatory practice will discuss results of the qualitative research and guide design of the optimal choice-based PrEP delivery model for Aim 2.

Aim 2: Offer PrEP choice to transgender people in a DSD model and evaluate implementation and effect on PrEP use (PROCEED).

We will offer choice of CAB-LA or oral PrEP, and choice of facility or community delivery (with option to switch), to 300 HIV-negative TGP with follow-up for 24 months. Adverse events, product switching, and trajectories of choice over time will be monitored and documented. Persistence on CAB LA and oral PrEP will be compared during the choice period, and with a historical cohort without PrEP choice (ClinicalTrials.gov, NCT04491422). Primary outcomes are choice of PrEP option & delivery model, adherence, and persistence.

Aim 3: Use mixed methods to evaluate how choice influences PrEP use among TGP (PROCEED).
Inductive and deductive analyses based on in-depth interviews with purposively sampled PrEP users (n=50) and providers (n=10) will be used to explain “how” and “why” choice did or did not work and interpret implementation data from Aim 2. Choice preferences will be assessed via structured questionnaires.

Aim 4: Estimate cost implications associated with integrating CAB LA into HIV programs.
We will conduct health system versus client cost analyses to inform budgeting. Costs incurred and averted will be estimated using activity-based micro-costing, study budget, and the literature. Costs and modeled outcomes will be combined to estimate budget impact with PrEP persistence at 6 and 12 months.


 Wakiso, Kasangati
 Uganda 2022-06-28 16:44:09 2025-06-28 420 Population: Trans women and men (up to 300 participants) Eligibility Eligible TGP must be aged ≥18, weigh ≥35kg, be interested in taking PrEP, at high risk for sexually acquiring HIV (i.e., any self-report of condomless sex, multiple partners, stimulant drug use or STIs) in the prior six months, and eligible for PrEP in accordance with Uganda National PrEP Guidelines United States National Institute of Mental Health (R01 MH130208) Medical and Health Sciences Clinical Trial Non-degree Award
Agnes Nyabigambo
ID:
Effectiveness of clinic-based patient-led HPV DNA self-sampling among HIV-infected women in Uganda.
REFNo: HS2084ES

1. To assess the difference and associated factors of uptake of clinic-based compared to home-based HPV self-sampling approach among HIV infected women in rural Uganda. 2. To identify factors associated with the prevalence of HPV among HIV-infected women in rural Uganda. 3. To determine factors influencing sample viability HPV self-collected samples in clinic arm compared with home -based arm. 4. To explore the facilitators and barriers of clinic-based compared to home-based HPV self-sampling approaches among HIV-infected women in rural Uganda. 5. To estimate the cost-effectiveness of the clinic-based approach compared to the home-based HPV-DNA self-sampling among HIV-infected women in rural Uganda.
Luweero, Kasana
 Uganda 2022-06-08 15:13:10 2025-06-08 382 Women living with HIV aged 25-49 years. HEARD PhD Scholarship Medical and Health Sciences Clinical Trial Degree Award
Joshua Muhumuza
ID:
Effect of chewing gum on duration of postoperative ileus following laparotomy for gastroduodenal perforations; a multi centre study.
REFNo: HS1665ES

i. To compare the time taken for post-operative ileus to resolve in the two groups. ii. To compare the duration of hospital stay in the two groups. iii. To determine other factors associated with the duration of post-operative ileus in the study population.
 Kabarole, Central Division
Bushenyi, Central Division
Hoima, Central Division
 Uganda 2022-05-30 17:10:09 2025-05-30 52 participants All adult patients 18 years and above, male and female admitted to the surgical wards of study centre hospitals irrespective of tribe with gastric or duodenal perforations during the study period at will be the study population self sponsored Medical and Health Sciences Clinical Trial Degree Award
Lisa Hartwig
ID:
The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
REFNo: HS2194ES

To assess the effectiveness of a behavioral intervention designed to encourage financial savings for healthcare costs and birth preparedness among pregnant women and their partners in Uganda. To examine whether increased earmarked financial savings for healthcare costs leads to increased utilization of maternal health services and male involvement in maternal healthcare.
 Kyotera, All
 USA 2022-05-23 9:28:49 2025-05-23 700 To be eligible for joining the study, the participants must fulfill the following eligibility criteria: (1) 18-49 years old, (2) Between 12-32 gestational weeks (pregnant female) OR partner of someone who is (male), (3) Own a mobile phone, (4) Has a regis The University of Tokyo Medical and Health Sciences Clinical Trial Degree Award
Achilles Katamba
ID: UNCST-2019-R000540
 Clinic versus Hotspot Active Case Finding and Linkage to TB Preventive Therapy (ACF/TPT) Strategy Evaluation for Tuberculosis
REFNo: HS2166ES

3. To estimate (using simulation) the impact of each intervention on diagnostic delays and TB prevalence.,2. To measure the implementation of hotspot-based and facility-based ACF + TPT, including the reach (number of individuals willing to be screened), implementation (measured via cascades of care), and maintenance (of effectiveness over time).,1. To compare the effectiveness of hotspot-focused versus facility-based ACF + linkage to TPT in terms of the number of individuals started on treatment for microbiologically confirmed TB in each community (i.e., reduction in undiagnosed TB prevalence, primary outcome) ,
 Lwengo,
Masaka, Kalisizo
Mpigi, Nkozi
Mityana, Mityana
Bugiri, Bugiri
Butambala, Gombe
Iganga, Iganga
Kiboga, Kiboga
Lyantonde, Lyantonde
Mukono, Mukono
Kayunga, Kayunga
Luweero, Luwero
Mubende, Kassanda
Jinja, Kawoolo
Buikwe, Kawolo
Nakaseke, Nakaseke
 Uganda 2022-05-18 9:43:01 2025-05-18 80000 All willing participants 15 years and above of any sex and tribe residing with the study area National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Herbert Kayiga Kayiga
ID:
EFFECTIVENESS, ACCEPTABILITY AND UPTAKE OF EARLY VERSUS STANDARD INTRAUTERINE CONTRACEPTION FOLLOWING PROVISION OF FIRST TRIMESTER MEDICAL POST ABORTION CARE IN CENTRAL UGANDA
REFNo: HS2111ES

1. To determine the proportion of women who take up IUC after mPAC for 1st trimester incomplete abortion. 2. To compare the expulsion rates at six months between early versus standard IUC insertions post mPAC treatment for first trimester incomplete abortion. 3. To compare the IUC continuation rates at six months between early versus standard IUC insertion post mPAC treatment for first trimester incomplete abortion. 4. To explore the women and their spouses' perception on Long Acting Reversible Contraceptives (LARC) and IUC following mPAC treatment. 5. To explore the Healthcare providers' perception on LARC and IUC following mPAC treatment.
Wakiso, Kasangati
Kampala, Namirembe
Buikwe, Kawolo
Mpigi, Mpigi
Luweero, Luweero
Mukono, Kawolo
Masaka, Masaka
Mityana,
Kayunga,
Gomba,
Uganda 2022-05-10 9:21:09 2025-05-10 2076 Women with first trimester incomplete abortion irrespective of tribe and nationality undergoing medical management will receive written and oral information about the study from the attending physician according to the principles of the Helsinki Declarati Prof Kristrina Gemzell Medical and Health Sciences Clinical Trial Degree Award
ANTHONY NUWA
ID: UNCST-2022-R011102
 A hybrid effectiveness-implementation study to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda
REFNo: HS2212ES

5) To monitor the safety and torelabilty of DP as compared to SPAQ among children 6-59 months in Karamoja when used in SMC,4) To understand the SMC implementation model, determining process, costing and acceptability outcomes for the intervention,3) To investigate the presence and change of SPAQ and DP resistance markers over time as a result of SMC implementation ,2) To determine chemoprevention efficacy of SPAQ and DP when used for SMC in Karamoja region, Uganda, and the extent to which efficacy is impacted by drug resistance and/or drug concentrations. ,1) To determine the effectiveness of SMC with DP and SPAQ in terms of its reduction in incidence of malaria infection among children aged 3–59 months,Phase 2 of this study aims to test the feasibility, effectiveness and chemoprevention efficacy of SMC with SPAQ and DP in Karamoja region in Uganda, where malaria transmission is highly seasonal, and inform malaria policy in Uganda. Accelerated adoption and scale-up of SMC will support efforts to accelerate progress in malaria control in high-burden countries.,
 Amudat, All
Nakapiripirit, All
Kotido,
Moroto, All
 Uganda 2022-05-05 11:23:22 2025-05-05 5550 3-59 months Bill and Melinda Gates Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 Performance evaluation of an improved point-of-care test (dual target) SAMBA HIV-1 qualitative test for early infant diagnosis of HIV-1 infection in resource-poor healthcare settings
REFNo: HS2219ES

To verify the field performance (sensitivity and specificity) of the improved, dual-target SAMBA II HIV-1 Qual Test against routine Cobas Ampliprep/Taqman HIV-1 Qualitative Test Version 2.0 (DBS)- for early diagnosis of HIV-1 in exposed infants and adults. In addition, discrepant results will be analysed using Cepheid Xpert HIV-1 Qual ,
 Uganda 2022-05-04 11:32:24 2025-05-04 0 Infants and Adults, between 1.5 months of age and all adults of all tribes Diagnostics for Real World (DRW) Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Muhanguzi
ID: UNCST-2019-R001101
 Evaluation of the Safety , Efficacy and Stability of Sangatraz®-125 & Sangatraz®-250: A Randomised Single-Blinded Positive Controlled Multi-Site Acaricides Field Trial
REFNo: A186ES

General objectives To determine the efficacy, safety and stability of Sangatraz®-125 & Sangatraz®-250(Sanga Vet. Chem. Ltd, Kampala Industrial Park, Namanve ) when applied onto cattle by hand spraying and plunge dipping for tick control. Specific objectives The specific objectives of this acaricide field trial will to to determine; i.efficacy of Sangatraz®-125 & Sangatraz®-250 when applied onto cattle by hand spraying and plunge dipping for tick control. ii.safety of Sangatraz®-125 & Sangatraz®-250 when applied onto cattle by hand spraying and plunge dipping for tick control. iii.Stability of Sangatraz®-125 & Sangatraz®-250 when applied onto cattle by plunge dipping for tick control.
Mayuge, Musoli
Mayuge, Wabulungu ward
Mayuge, Katonte
Mayuge, Nkombe
Gomba, Madu Parish
Gomba, Kyayi Parish
,
Uganda 2022-04-25 2025-04-25 n= 1,579 Cattle on 10 farms [5 farms in Gomba District and the other 5 from Mayuge District]. These will be both female and males above 2 months of age. All cattle breeds will be recruited Sanga Vet. Chem. Ltd P.O Box 75164 | Plot 1144, Kampala Industrial Business Park | Kampala-Uganda Tel: 02008000100 | Web: https://www.sangavetchem.com/ Agricultural Sciences Clinical Trial Non-degree Award
Etheldreda Nakimuli-Mpungu
ID: UNCST-2020-R014808
 Tele-Psychotherapy for Youth using Mobile Phones during Covid-19 Pandemic
REFNo: HS2106ES

1. We aim to conduct online and community-based participatory qualitative research to obtain information on the potential usefulness of individual tele-support psychotherapy in addressing depression during the Covid-19 pandemic.
2. We will compare the effectiveness of individual tele-support psychotherapy (TSP) delivered by trained lay counsellors in combination with standard mental health services (SMHS) for depression with use of SMHS alone.
3. We aim to compare the effects of TSP combined with SMHS and SMHS alone on other psychosocial variables including self-esteem, anxiety, alcohol and substance use, social support, stigma, number of disability days, asset possession, poverty indices, and cost-effectiveness measures.
4. To conduct a process evaluation of trial activities informed by Linnan and Steckler’s process evaluation frameworks to specifically determine indicators of feasibility, acceptability, fidelity, and to explore causal mediating processes and contextual influences
5. We will also explore whether or not the effects of TSP and SMHS are moderated by alcohol and drug use.
6. We shall explore whether the strength of a therapeutic relationship will mediate the effects of TSP and SMHS on depression
 Kampala, Makerere
Kampala, Kamwokya Parish
Kampala, Naguru Ii Parish or Go down
 Uganda 2022-04-21 2025-04-21 300 To be eligible for the study, each participant must be 15-30 years old, diagnosed with significant depression symptoms assessed with the self reporting questionnaire, residing in Naguru Go-down and Kamwokya slums, or Makerere University campus. USAID (DIV) Medical and Health Sciences Clinical Trial Non-degree Award
Nahwera Loyce
ID:
EFFECTS OF 12-WEEKS AEROBIC DANCE ON BLOOD PRESSURE, PERCENT BODY FAT AND hs-CRP IN HYPERTENSIVE PATIENTS ATTENDING KYAMBOGO MEDICAL CENTRE, UGANDA
REFNo: HS2202ES

1. To establish the baseline systolic and diastolic blood pressure, percent body fat and hs-CRP levels in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.
2. To determine the effect of a 12-week aerobics dance programme on Systolic Blood Pressure (SBP) levels in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.
3. To determine the effect of a 12-week aerobics dance programme on Diastolic Blood Pressure (DBP) levels in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.
4. To establish the effect of a 12-week aerobics dance programme on percent body fat in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.
5. To determine the effect of a 12-week aerobics dance programme on hs-CRP levels in stage 1 hypertensive patients attending Kyambogo University Medical Centre in Kampala, Uganda.

Kampala, Kyambogo
 Uganda 2022-04-19 2025-04-19 76 participants ( 34 in both experimental and control group) The target population will be stage 1 hypertensive patients attending KUMC. The study focuses on age group 30-55 years. Regional Universities Forum for Capacity Building in Agriculture Medical and Health Sciences Clinical Trial Degree Award
Haruna Muwonge
ID: UNCST-2019-R000128
 A Randomized, Double-Blinded, Placebo-Controlled, Phase III, Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above
REFNo: HS2185ES

Safety: To evaluate adverse events from the first dose and the booster dose to Day 28 after the whole-course immunization and serious adverse events from the first dose and the booster dose to at least 12 months after the whole-course immunization,Efficacy: To evaluate the efficacy of the SARS-CoV-2 Vaccine, Inactivated (Vero Cell) for symptomatic and laboratory-confirmed (RT-PCR method) COVID-19 cases caused by different SARS-CoV-2 variants,Immunogenicity: To evaluate the immune persistence of the investigational vaccine,Immunogenicity: To demonstrate the consistency of 3 lots of investigational vaccine in terms of GMT 14 days after the whole-course immunization,Immunogenicity: To evaluate the levels of neutralizing antibody and IgG antibody against SARS-CoV-2 14 days after the whole-course and after the booster immunization,Efficacy: To evaluate the efficacy of the SARS?CoV?2 Vaccine, Inactivated (Vero Cell) against symptomatic and laboratory-confirmed (RT?PCR method) severe COVID-19 disease,Efficacy: To evaluate the efficacy of the SARS?CoV?2 Vaccine, Inactivated (Vero Cell) after at least one dose, 2 doses, and after the booster dose of immunization,To evaluate the efficacy, safety and immunogenicity of the SARS?CoV?2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after a 2-dose schedule, and after booster vaccination,
 Kayunga, Ntenjeru
Jinja, Nakasero
Mityana, Central Ward
Mubende, Kyaterekera
Gulu, Agwee
Wakiso, Central Ward
Mukono, Ggulu Ward
Kampala, Mulago I
 Uganda 2022-04-07 2025-04-07 5000 Adults 18years and above, male and female, all tribes that fulfill the study inclusion criteria Institute of Medical Biology Chinese Academy of Medical Sciences Medical and Health Sciences Clinical Trial Non-degree Award
Miriam Nakalembe
ID: UNCST-2021-R014040
 Simplified Treatment for Eclampsia Prevention using Magnesium sulfate: A phase III, randomized, open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial).
REFNo: HS2076ES

The primary objective of this trial is to evaluate non-inferiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen1 in the prevention of maternal eclamptic seizure.

The secondary objective of this trial is to evaluate superiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen in the proportion of women experiencing adverse events indicative of magnesium toxicity.
 Kampala, Kawempe
 Uganda 2022-04-02 2025-04-02 1500 Uganda The target trial population are women admitted to participating hospitals with pre-eclampsia during pregnancy, labour or within 24 hours of childbirth, whether it involves a single or multiple gestation. World Health Organisation Medical and Health Sciences Clinical Trial Non-degree Award
Thereza Piloya Were
ID: UNCST-2019-R000491
 Diabetes in African Youth: Improving Glucose Time-In-Range (DAY Time) Randomized Clinical Trial.
REFNo: HS2129ES

Primary Study Objectives
1. To determine if patient ability to continuously observe plasma glucose levels for 6 months using a flash intermittently scanned CGM improves glucose TIR compared to baseline. The change in glucose TIR while wearing the unblinded CGM will be compared to change in TIR in patients performing 3x/day SMBG (wearing a blinded CGM for endpoint measurement).
2. To perform a cost analysis on flash glucose monitoring compared to 3x/day SMBG, to determine whether this technology is cost effective in the setting of a low-resource nation.
Secondary Objectives: To assess the change-from-baseline impact of unblinded CGM on:
1. Percent time-in-range at 12 months
2. Percent time with glucose 180-250, >250, <70, and <54 mg/dl at 6 and 12 months
3. HbA1c at 6 and 12 months
4. Patient satisfaction and quality of life at 6 and 12 months
5. Glucose variability (coefficient of variation, CV) at 6 and 12 months

 Kampala, Mulago
Kampala, Nsambya
 Uganda 2022-04-01 2025-04-01 180 randomized in 2 groups : - 90 per group Inclusion Criteria ? Children and youth in Uganda, age 4-26 years at baseline ? T1D of at least 12 months duration at baseline ? Receiving insulin therapy ? Access to a cell phone (nearly ubiquitous in Uganda, even in remote areas) ? Participant/pare United States of America, National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Performance evaluation of the CheckNOW™ HIV Self-Test study
REFNo: HS2170ES

1. To evaluate the performance (Sensitivity and specificity) of the CheckNOW™ HIV SELF TEST when compared to the Genscreen ULTRA HIV1/2 Ag/Ab EIA followed by the Murex diasorin HIV1/2 Ag/Ab combination (reference testing) in the laboratory and the national testing algorithm.

2. To describe the clinical performance (sensitivity and specificity) of the CheckNOW™ HIV SELF TEST, as obtained by the professional users, when compared to the reference testing and the national testing algorithm.

3. To describe the clinical performance (sensitivity and specificity) of the CheckNOW™ HIV SELF TEST, as obtained by the lay users, when compared to the reference testing and the national testing algorithm.

4. To assess the accuracy of the lay user interpretation of the HIVST result. This will be compared with the interpretation by the RA.
5. To assess the usability of the CheckNOW™ HIV SELF TEST. The usability of the test will be evaluated by questionnaires completed by the study staff observers and by the lay users.



Kampala, Kampala
Kalungu, Kalungu
Kayunga, Kayunga
Mukono, Mukono
 Uganda 2022-04-01 2025-04-01 1000 Adults aged 18 years and above who are willing to have an HIV test. - Abott Diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 Suubi4Stronger Families: Addressing Child Behavioral Health by Strengthening Financial Stability and Parenting among Families in Uganda
REFNo: SS1205ES

The study examines the mechanisms by which economic empowerment (EE) and family strengthening (FS) interventions targeting social, familial and context-specific drivers affect childhood behavioral health.

Specific aims of the study are:

Aim 1: Examine the impact of EE only, MFG-based FS only, and combined EE+MFG-based FS on children’s DBD symptoms and behavioral functioning.

Aim 2: Test the influence of EE only, MFG-based FS only, and combined EE+MFG-based FS on family financial stability (e.g., food and housing stability, material assets, savings), parenting and protective family
processes (e.g., family organization, caregiver/child interaction, cohesion, support) and perceptions related to
help seeking (e.g., stigma) on CBH and functioning; and assess whether these change mechanism mediate intervention effects on DBD symptoms and behavioral functioning, and explore moderation by context specific moderators of intervention effects.

Aim 3: Qualitatively examine participants’ experiences with each intervention arm.
 Masaka, Kimaanya
Rakai, Kakuuto
Kyotera, Kyotera TC
Lwengo, Lwengo
Kalungu, Bukulula
 Uganda 2022-03-30 2025-03-30 900 A total of 900 primary-school-going children (ages 10-14 at enrollment) in upper primary (the last 3 year of primary school: P5-P7), both male and female will be enrolled and followed for three school-academic terms(12 months). To avoid stigma that surro National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
SIMON ARUNGA
ID: UNCST-2021-R013498
 Cluster randomised controlled trial of a complex intervention package to reduce blindness from severe microbial keratitis in Uganda.
REFNo: HS1814ES

To determine if a complex intervention package delivered at the Primary Health Centres (PHCs) including early recognition, prompt chlorhexidine 0.2% treatment and rapid referral can result in reduced rates of blindness from severe MK at three months
 Ntungamo, All parishes
Isingiro, All parishes
 Uganda 2022-03-21 2025-03-21 Participants Individuals with corneal abrasions and corneal infection (microbial keratitis) presenting at the cluster primary health centres in these two districts in South Western Uganda will be elig All individuals aged 18 and above, of all sexes in the two districts London School of Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Johanna  Blomgren
ID: UNCST-2021-R012309
 MIDWIZE - Strengthening midwives to implement and sustain quality improvements to optimise maternity care: A longitudinal observational study in Uganda
REFNo: HS1885ES

This PhD project aims to explore how midwives can take the lead in implementing or enhancing QI components within maternal health care in Uganda. The overall goal of this project is to improve the health of women and newborns. The way to achieve this is through enhancing the quality of care by capacitating midwives. Sub-study 1 - Co-creating and developing the intervention and the implementation Specific objectives: To explore multisectoral stakeholders' perspectives and ideas on how to strengthen midwives' capacity to implement QI components. To explore which QI components the midwives will implement or enhance. Sub-study 2 - Implementation and evaluating the sustainability of the implementation Specific objectives: -To measure the uptake of evidence-based QI components when midwives lead, organise and provide enhanced intra- and postpartum care. -To measure the long-term sustainability of the midwives' QI projects. Sub-study 3 – Process evaluation Specific objective: To evaluate the process of strengthening midwives' capacity to implement QIs in maternal care.
 Kampala,
Sweden 2022-03-21 2025-03-21 668 Study 1 Midwives at Naguru hospital, women and their relatives, other professionals and managers, multisectoral stakeholders (professional association, education, policymakers) Study 2 Pregnant women above 18 years in the uptake area. However, dependin Karolinska Institutet Medical and Health Sciences Clinical Trial Degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A Randomized, Observer-Blind, Phase 2 Clinical Trial of COVAC-2 in Generally Healthy Adults
REFNo: HS2124ES

Primary Objective:
• To evaluate the safety and tolerability of the COVAC-2 vaccine (25 ?g dosing of S1 antigen) in generally healthy adults ages 18+.
Secondary Objectives:
• To determine spike-binding and pseudovirus neutralizing antibody responses against the Wuhan strain of SARS-CoV-2 induced by COVAC-2; and
• To determine a cellular immune response induced by COVAC-2.
Exploratory Objectives:
• To determine Receptor-Binding Domain (RBD)-binding antibody responses induced by COVAC-2; and
• To determine the neutralizing antibody response induced by COVAC-2 against one or more Variant(s) of Concern (VOC) and/or Variant(s) of Interest (VOI).


Wakiso, NOT APPLICABLE
Mbarara, NOT APPLICABLE
Masaka, NOT APPLICABLE
 Uganda 2022-03-21 2025-03-21 300 The target population for this Phase 2 study is generally healthy adults of diverse gender ? 18 years of age. The target indication for the candidate COVAC-2 vaccine is adults because they are a population that experiences significant age-related COVID-19 The study is funded by the Government of Canada through the University of Saskatchewan’s Vaccine and Infectious Disease Organization (VIDO). Medical and Health Sciences Clinical Trial Non-degree Award
Pauline Byakika-Kibwika
ID: UNCST-2019-R001206
 Exposure-Response Evaluation of IV Artesunate in Children with Severe Malaria
REFNo: HS2027ES

Primary:
• To determine the relationship between dihydroartemisinin (DHA) exposures following intravenous dosing and markers of physiologic dysfunction associated with severe malaria
Secondary:
• To determine the relationship between DHA exposures and time to hospital discharge
• To determine the relationship between DHA exposures and parasite clearance associated with treatment of severe malaria.
Exploratory:
• To determine the relationship between DHA exposures and neurodevelopmental outcomes associated with treatment of severe malaria outcomes and explore predictors that may affect this relationship
• To evaluate the role of parasite clearance as a mediator of the relationship between DHA exposures and markers of physiologic dysfunction associated with severe malaria
• To develop a score comprised of markers of physiologic dysfunction and describe its relationship to clinical outcomes
• To assess P. falciparum infections for artemisinin resistance

Tororo, central division
 Uganda 2022-03-14 2025-03-14 100 Children with severe malaria who are 6 months to 14 years of age living in or near Tororo District, Uganda VTEU Contract HHSN2722013000221 Medical and Health Sciences Clinical Trial Non-degree Award
Joseph Ngonzi
ID: UNCST-2019-R001579
 Automated visual evaluation and geospatial mapping for cervical cancer screening optimization in sub-Saharan Africa (AVE-Map)
REFNo: HS2069ES

3. To use AVE and geospatial analysis to scale up cervical cancer screening in Uganda ,2. To determine access to cervical cancer screening and referral pathways in Uganda ,1. To validate and expand use of AVE for cervical cancer screening in SSA ,We aim to leverage and develop data science expertise at our sites to first optimize and then combine AVE-based screening by health workers at peripheral health facilities with geospatial-analysis and needs-driven assessment to inform scale-up of cervical cancer screening in Uganda ,
 ,
Mbarara, Kakoba
 Uganda 2022-02-28 2025-02-28 2000 Females aged 25 years and above NATIONAL INSTITUTE OF HEALTH Medical and Health Sciences Clinical Trial Non-degree Award
Musa Sekikubo
ID: UNCST-2021-R014010
 A placebo controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants
REFNo: HS1991ES

1. To describe the safety and tolerability of GBS6 when administered at ? 27 0/7 to ? 35 6/7 weeks’ gestation to pregnant women, with and without HIV, aged ? 18 to ? 40 years of age and their infants..
2. To assess the safety of GBS6 in infants born to HIV positive and negative women who were vaccinated during pregnancy.

 Kampala, Kawempe
Kampala, Kisenyi
Uganda 2022-02-11 2025-02-11 300 pregnant women aged 18 to 40 years at gestation age of ? 27 0/7 to ?35 6/7 weeks. St George’s, University of London Cranmer Terrace SW17 0RE Medical and Health Sciences Clinical Trial Non-degree Award
Aisha Nanyiti
ID: UNCST-2021-R013489
 A Randomized Control Trial (RCT) on the Adoption of Liquefied Petroleum Gas (LPG) Cooking Technology among Fast Food (Chapati) Vendors in Uganda
REFNo: SS1017ES

This study seeks to establish the impact of hire purchase schemes and health and safety information on adoption of LPG cookstoves by chapati vendors.

This study will achieve the following specific objectives:
1) The impact of learning from LPG use in grace period before purchase armotisation on adoption of LPG cookstoves by chapati vendors for their businesses and households.
2) The impact of hire purchase on adoption of LPG cookstoves by chapati vendors for their businesses and households.
3) The impact of information on safety and health benefits of LPG on adoption of LPG cookstoves by chapati vendors for their businesses and households.
4) The impact of peer learning from other vendors using LPG cookstoves on adoption of LPG cookstoves by chapati vendors for their businesses and households.
 Kampala,
Uganda 2022-02-10 2025-02-10 210 chapatti vendors; they are mainly males of age range in 18-45 years from all districts of Uganda. Environment for Development Initiative Social Science and Humanities Clinical Trial Non-degree Award
Robert Kalyesubula
ID:
Effectiveness of a community health worker delivered care intervention for hypertension control in Uganda: a stepped wedge, cluster randomized control trial.
REFNo: HS1917ES

To assess the effectiveness of a CHW-delivered intervention for hypertension control in Uganda.,
 Nakaseke, Kigegge, Bulwadda, Mifunya, Kyamutakasa, Kasambya, Kasagga, North Ward. East Ward. Namilali, Kivule Central Ward
 Uganda 2022-02-10 2025-02-10 900 Hypertensive patients, 18 years and above, attending Nakaseke hospital or Life Care NCD clinics, and residing either in Nakaseke town council, Nakaseke Subcounty or Kasangombe. Else Kroner Fresenius Stiftung Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes among Adolescents Living with HIV in Uganda
REFNo: SS1166ES

Aim 1: Examine the impact of M-Suubi on HIV viral suppression (primary outcome); and adherence to HIV treatment (keeping appointments, pharmacy refills, pill counts), and retention in care (secondary outcome).

Aim 2: Examine the effect of M-Suubi on Stigma (internalized anticipated, and enacted), with secondary analyses to explore hypothesized mechanisms of change (e.g. depression) and intervention mediation.

Aim 3: Assess the cost and cost-effectiveness of each intervention condition.

Aim 4: Qualitatively examine: a) participants’ experiences with HIV stigma, HIV treatment adherence, and the intervention; and 2) educators’ attitudes towards ALHIV and experiences with GED-HIVSR, and program/policy implementation post-training.

Aim 5: Conduct formative work (focus group discussions) to understand the needs of depressed ALHIV.

 Masaka, Kimaanya
Kalungu, Bukulula
Rakai, Kakuuto TC
Lyantonde, Lyantonde TC
Bukomansimbi, Butenga
Lwengo, Lwengo
 Uganda 2022-02-04 2025-02-04 840 dyads The target populations for this study will be ALHIV, their caregivers (N=840 child-caregiver dyads), and administrators attending 42 boarding schools in the greater Masaka region. Participants will be included in the study if they meet the following inclu National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
Emmy Okello
ID: UNCST-2020-R009792
 Remote Ischaemic Conditioning in STEMI patients in sub-Saharan AFRICA: The RIC-AFRICA trial
REFNo: HS1865ES

RIC will reduce the rates of all-cause death and early post-myocardial heart failure by approximately 25% when compared to sham control.,The RIC-AFRICA trial will investigate the effect of RIC in STEMI patients on the rates of all-cause death and early post-MI heart failure (pre-discharge HF and hospitalisation for HF at 30 days post-MI,) when compared to sham control,
 ,
Kampala, MULAGO
 Uganda 2022-02-01 2025-02-01 1500 Participants will be recruited from the Uganda Heart Institute and other nearby state and private hospitals with STEMI care with in Uganda and other collaborating sites in Sub-Saharan countries Mancherje-Potash Foundation, USA Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Mukonzo
ID: UNCST-2021-R013916
 Safety and Efficacy of COVIDEX™ Therapy in Management of adult Covid-19 Patients in Uganda: A randomized double-blind placebo controlled adaptive phase 2 B clinical trial.
REFNo: HS2041ES

3. To determine the plasma concentration of berberine in COVID-19 patients receiving COVIDEX. ,2. To determine the efficacy of COVIDEXTm for treatment of COVID-19 among adults in Uganda.,To determine the efficacy of COVIDEXTm for treatment of COVID-19 among adults in Uganda.,To validate the safety and determine the efficacy of COVIDEXTm therapy for treatment of COVID-19 in adult Ugandans. ,
 Mbarara, kakoba
Kampala, mulago 1
 Uganda 2022-01-25 2025-01-25 584 Participants who are categorized as mild score 2 (limitation of activities), moderately ill COVID-19 patients score 3 (Hospitalized with no oxygen therapy), score 4(Hospitalized with oxygen by mask or nasal prongs) and hospitalized severe disease score 5 JENA HERBALS LTD, MINISTRY OF HEALTH UGANDA Medical and Health Sciences Clinical Trial Non-degree Award
Susanne Guidetti Gittel Eleonora
ID: UNCST-2021-R012422
 Participation in everyday life - A randomized controlled trial of mobile phone-supported and family-centred rehabilitation after stroke in Uganda
REFNo: HS1528ES

General objective (Overall aim)
To implement and evaluate the effects a mobile phone supported and family-centred rehabilitation intervention F@ce 2.0 aiming to enable performance in daily activities and participation in everyday life among persons who have had a stroke and their family members both in urban (Kampala and its surroundings) and rural (Greater Masaka) areas.

Specific objectives
• To describe the perceived impact of stroke and perceived participation in everyday life in a sample of people with stroke in rural Uganda. (Study 1)
• To evaluate the effects of F@ce in comparison with ordinary rehabilitation among persons with stroke in urban and rural Uganda regarding a) self-efficacy b) perceived performance and participation in everyday activities c) independence in ADL, d) healthcare utilization and e)their families´ perceived participation in everyday activities.(Study 2)
• To explore and describe the experiences of people with stroke and family members of participating in the F@ce (Study 3)
• To evaluate the implementation process of F@ce and to gain knowledge on the mechanisms of impact as well as the contextual factors that might influence the implementation process and its outcome. (Study 4)
• To determine the cost of delivering the F@ce intervention in comparison with the usual rehabilitation (Study 5)

 Kampala,
Masaka,
Iganga,
Sweden 2022-01-19 2025-01-19 174 The sample size will accommodate for an attrition rate of 10%, based on our pilot study in Uganda, therefore will require the inclusion of a total of 174 participants with stroke, 15 health professionals and 15 caregivers (family members). The study will The Swedish Research Council Medical and Health Sciences Clinical Trial Non-degree Award
Maria NAKACHWA
ID:
Mobile Telephone Communication and Utilization of Antenatal Care Services During Pregnancy. A Case Study of Kyotera and Rakai Districts- Uganda
REFNo: HS1957ES

d. To develop a model for the prediction of ANC uptake when mobile telephone communication is used.,c. To evaluate effects of patient factors in the utilization of antenatal care services among expectant mothers in Kyotera and Rakai Districts , Uganda.,b. To assess patient factors influencing mobile telephone communication among expectant mothers in Kyotera and Rakai Districts, Uganda.,a. To examine effects of mobile telephone communication on the utilization of antenatal care services among expectant mothers in Kyotera and Rakai Districts, Uganda.,
 Rakai, Kitente
 Uganda 2022-01-12 2025-01-12 2214 THE STUDY POPULATION CONSTITUTES OF EXPECTANT MOTHERS AGED 15 TO 49 YEARS RESIDING IN KYOTERA AND RAKAI DISTRICTS FROM ALL THE TRIBES IN THESE COMMUNITIES. SELF SPONDORED Medical and Health Sciences Clinical Trial Degree Award
David Lubogo
ID: UNCST-2020-R014473
 Metabolic Syndrome among Females of Reproductive age in Wakiso district, Central Uganda: Risk factors and Effectiveness of a Community based Nutrition Education Intervention
REFNo: HS1281ES

General objective: To investigate the prevalence of, and factors associated with metabolic syndrome (MetS) and evaluate the effect of a community based nutrition education intervention among females of reproductive age with MetS in Wakiso district, Central Uganda in order to contribute information for the design of interventions for MetS.
Specific objectives
1. To determine the prevalence of, and factors associated with Metabolic Syndrome.
2. To determine optimal WC cut off points for MetS.
3. To determine the effectiveness of a 12 -week community-based nutrition education and counseling intervention for metabolic syndrome on selected cardiovascular outcomes (BP), biochemical outcomes (HDL, TGS, blood sugar), anthropometric measures (WC, weight), behavioral outcomes (dietary intake, physical activity), and on knowledge as an outcome.
4. To explore the female and health care provider perceptions/perspectives towards the nutrition promotion intervention on MetS among female of reproductive age in South Central Uganda.

 Wakiso,
Wakiso,
Uganda 2021-12-28 2024-12-28 840 Females aged 15- 49 years in Wakiso district. Strengthening Education and Training Capacity in Sexual and Reproductive Health and Rights in Uganda (SET-SRHR) and the Government of Uganda Medical and Health Sciences Clinical Trial Degree Award
JIM ARINAITWE
ID: UNCST-2021-R012572
 Quit4Life: Adapting and Evaluating a Phone-Based Tobacco Uses Cessation Program for People Living with HIV in Uganda and Zambia.
REFNo: HS1762ES

The goal of the study is to adapt and evaluate the efficacy of a phone-based tobacco cessation intervention for PLWH in Uganda and Zambia in five years. The primary objective of the study is to promote smoking cessation among HIV infected persons. Specifically, 1) adapt a standard short message service (SMS) for tobacco cessation program, 2) Nicotine Replacement Therapy, 3) compare the efficacy of our SMS-based program tailored to meet the needs of PLWH (Quit4Life+) to the current standard of care.
Arua, Adumi HCIV, Omugo HCIV and River Oli HCIV
Moroto, Loputuk HCIII, Nadunget HCIII and Tapac HCIII
 Uganda 2021-12-28 2024-12-28 Total Sample size is 800 with 400 from Uganda and 400 from Zambia The study will include males and females of consenting age attending HIV services at Health III, IV, District/Regional Referral Hospitals National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
JULIET MWANGA-AMUMPAIRE
ID: UNCST-2022-R009420
 An open-label, multicentre, randomized, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild/moderate cases of COVID-19
REFNo: HS1789ES

Primary objective: to compare the efficacy of alternative treatment strategies versus control on the risk of progression to severe respiratory disease
The secondary objectives are:
 To compare the safety of each study arm to control, up to Day 21 of follow-up
 To compare the rate of hospitalizations due to COVID-19 in each study arm versus control
 To compare the time to hospitalization due to COVID-19 in each study arm versus control
 To compare the rate of hospitalizations for other reason than Covid-19 in each study arm versus control
 To compare the disease-free rate in each study arm versus control
 To compare the death rate in each study arm versus control
 To compare time to worsening of SpO2 < 93in each study arm versus control
 To compare the capacity to prevent severe progression between study arms
 To identify risk factors for severe progression
 To assess efficacy in sub-groups of patients e.g. with pre-existing conditions/co-morbidities, by age group, sex, BMI, timeframe between onset of symptoms and randomization.

 Mbarara, Mbarara Medical Cell
 Uganda 2021-12-07 2024-12-07 175 1. Male or female patients, 2. Adult’s  18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis. 3. COVID-19 confirmed by molecular biology or validated antigenic test Drugs for Neglected Diseases Initiative (DNDi) Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 PURPOSE 1: GS-US-412-5624/ A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection. Version 2.0, dated 10 March 2021.
REFNo: HS1920ES

1. Primary Objectives i) To evaluate the efficacy of LEN for HIV PrEP in AGYW at risk of HIV infection. ii) To evaluate the efficacy of F/TAF for HIV PrEP in AGYW at risk of HIV infection. 2. Secondary Objectives/ end points i) To compare the efficacy of LEN with F/TDF for HIV PrEP in AGYW at risk of HIV infection. ii) To evaluate the efficacy of LEN for HIV PrEP in AGYW at risk of HIV infection in participants adherent to LEN. iii) To evaluate the efficacy of F/TAF for HIV PrEP in AGYW at risk of HIV infection in participants adherent to F/TAF. iv) To compare the efficacy of F/TAF with F/TDF for HIV PrEP in AGYW at risk of HIV infection. v) To evaluate the safety and tolerability of LEN, F/TAF, and F/TDF for HIV PrEP in AGYW at risk of HIV infection. vi) To evaluate the safety and tolerability of LEN and F/TAF for HIV PrEP in AGYW ≥ 16 to < 18 years of age who have sex with male partners and are at risk for HIV infection. 3. Exploratory objectives i) To assess the adherence rate to LEN as assessed by on-time LEN injection ii) To assess LEN plasma levels iii) To assess the adherence rate to F/TAF and F/TDF using intracellular TFV-DP levels in DBS. iv) To evaluate the acceptability of a once every 26 weeks LEN injection for HIV PrEP in AGYW at risk of HIV infection. v) To assess LEN plasma levels during pregnancy. vi) To explore concentrations of hormonal contraceptives in LEN participants.
Mityana, Mityana
Hoima, Hoima county
Masaka, Masaka
Kalangala, Kalangala
 Uganda 2021-11-25 2024-11-25 The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a randomized blinded study (Randomized Phase). The Incidence Phase of the study will remain open until the backg Cisgender AGYW who have sex with male partners, at risk for HIV infection ≥ 16 to ≤ 25 years of age. Gilead Sciences Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Kamya Moses
ID: UNCST-2020-R014203
 Enhancing immunity to malaria in young children with effective chemoprevention
REFNo: HS1763ES

To compare the incidence of malaria from 4 weeks to 4 years of age among children born to mothers randomized to receive intermittent preventative therapy in pregnancy (IPTp) with monthly sulfadoxine pyrimethamine (SP) alone, monthly DP alone, or both monthly SP+DP.

To compare the incidence of malaria from 2-4 years of age among children randomized to receive IPT in childhood (IPTc) with monthly DP from 8 weeks to 1 year of age vs. monthly DP from 8 weeks to 2 year of age vs. no IPTc.

To compare innate and adaptive effector and regulatory responses between children randomized to different IPT arms.

Busia, Masafu
 Uganda 2021-11-24 2024-11-24 924 HIV-uninfected infants Children both male and female, 4 weeks to 4 years of age, resident of Busia District Division of Microbiology and Infectious Diseases (DMID) Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)
REFNo: HS1813ES

1.1 Co-Primary Objectives 1.1.1 Phases II and III: To evaluate safety of the investigational agent. 1.1.2 Phase II: To determine efficacy of the investigational agent to reduce the duration of COVID-19 symptoms through study day 28. 1.1.3 Phase II: To determine the efficacy of the investigational agent to increase the proportion of participants with nasopharyngeal (NP) SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) at study days 3, 7, and 14. 1.1.4 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study day 28. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic. 1.2 Secondary Objectives 1.2.1 Phases II and III: To determine whether the investigational agent reduces a COVID-19 Severity Ranking scale based on COVID-19-associated symptom burden (severity and duration), hospitalization, and death, through study day 28. 1.2.2 Phase II and III: To determine whether the investigational agent reduces the progression of COVID-19-associated symptoms. 1.2.3 Phase II and III: To determine if the investigational agent reduces levels of SARS-CoV-2 RNA in NP swabs. 1.2.4 Phase III: To determine the efficacy of the investigational agent to increase the proportion of participants with NP SARS-CoV-2 RNA below the LLoQ at study day 3. 1.2.5 Phase II: To determine the pharmacokinetics of the investigational agent. 1.2.6 Phase II: To determine efficacy of the investigational agent to obtain pulse oximetry measurement of ≥96% through day 28. 1.2.7 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study week 72. 1.2.8 Phase III: To evaluate if the investigational agent reduces the time to sustained symptom resolution through study day 28.
Wakiso,
Mpigi,
Mukono,
Uganda 2021-11-22 2024-11-22 The phase II evaluation will enroll approximately 110 participants per investigational agent (and 110 on placebo) (this includes all participants enrolled under previous protocol versions, irrespectiv Outpatient adults (≥18 years) with a documented positive SARS-CoV-2 molecular (nucleic acid) or antigen test from a sample collected ≤240 hours (10 days) prior to study entry and with ≤7 days of symptoms of COVID-19 at study entry, plus the presence The National Institute of Allergy and Infectious Diseases, Division of AIDS/NIAID/NIH/DHHS, Rockville, Maryland 20892 USA Medical and Health Sciences Clinical Trial Non-degree Award
Francis Ssali
ID: UNCST-2021-R012134
 A Phase 2, Open-label, Single-arm, Multicentre Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to less than 12 years) who are Virologically Suppressed (TMC278HTX2002)
REFNo: HS1815ES


Primary Endpoints
• Area under the plasma concentration-time curve from the time of administration up to 24 hours post-dose of RPV, as derived from the intensive PK assessments.
• Incidence of grade 3/4 AEs, SAEs, HIV-related events (including acquired immune deficiency syndrome [AIDS]-defining illnesses and Stage-3-defining Opportunistic Illnesses in HIV Infection), and AEs leading to discontinuation of study intervention through 24 weeks of study treatment.

Secondary Endpoint
• Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment.
• Change from baseline Movement.
• Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment.
• Treatment adherence, as assessed by the Pediatric European Network for the Treatment of AIDS (PENTA) adherence questionnaire and by study intervention accountability, through 24 and 48 weeks of study treatment.

 Wakiso, Makindye
,
Uganda 2021-11-22 2024-11-22 lower limit is 3 and Upper limit is 10 Participants (boys and girls) aged ≥2 to <12 years with a bodyweight of at least 11 kg Janssen Sciences Ireland Unlimited Company Medical and Health Sciences Clinical Trial Non-degree Award
Jerome  Kabakyenga Kahuma
ID: UNCST-2021-R013729
 The A-Lite vein locator: “a non-invasive assistive medical device designed to improve vein visibility among patients requiring intravenous therapy.”
REFNo: HS1547ES

Main Objective
1. To assess the efficacy, safety and impact of using an assistive medical device to aid vein visibility among patients requiring intravenous therapy.

Specific Objectives
1. To assess the safety and efficacy of the A-Lite vein locator among 10 adults in Uganda.

2. To investigate non-inferiority by assessing the performance of the A-Lite vein locator with respect to the existing standard of care among 48 adolescents in Uganda.

3. To determine the effectiveness of using the A-Lite vein locator for improving vein visibility among 156 children requiring intravenous cannulation in Uganda.
 Kalungu, Bugonzi
Lira, Junior Quarters
Mbarara, Rwebishekye
Isingiro, Kashojwa
 Uganda 2021-11-19 2024-11-19 214 Ages eligible for the study: 1 up to 30 years Sexes eligible for the study: All International Development Research Centre (IDRC) – Canada and the Government of Uganda Medical and Health Sciences Clinical Trial Non-degree Award
ANGELLA MUSIIMENTA
ID: UNCST-2021-R013297
 My Mobile Wallet: An Intervention to Support Access to Tuberculosis Care and medication Adherence in Rural Uganda
REFNo: HS1688ES

Assess the refined My Mobile Wallet intervention for larger scale feasibility, acceptability, and impact on TB treatment adherence and clinical outcomes. We will randomize 162 newly diagnosed TB patients (1:1:1) to SMS texts + incentives Arm A, SMS texts only B, and control Arm C (standard clinic-based TB care); follow-up will be the 6 month-treatment period. Feasibility and acceptability will be assessed per above. Impact will be based on electronically monitored medication adherence (primary), as well as treatment completion, clinic attendance, cure, and mortality (secondary).,Refine the My Mobile Wallet intervention. We will adapt the intervention to address any feasibility and accessibility issues raised in R21 findings. We will then pilot test the refined version of the intervention in 10 TB patients over two months of treatment to ensure optimal functionality. ,Assess the initial feasibility and acceptability of My Mobile Wallet. Forty patients with newly diagnosed TB will use My Mobile Wallet over their 6-month course of treatment. Feasibility will be assessed by appropriate receipt of the cash transfers and SMS texts, and intervention functionality. Acceptability will be assessed using System Usability Scale [53] and interviews based on the Unified Theory of Acceptance and Use of Technology [54].,Determine the optimal design and develop My Mobile Wallet as an intervention to support TB medication adherence. Through client-centered approaches, we will iteratively conduct focus group discussions with up to 30 TB patients to develop an optimal My Mobile Wallet intervention.,
 Mbarara, Kamukuzi
Mbarara,
Uganda 2021-11-19 2024-11-19 242 TB patients (18 and above years old) living not beyond 60 Kilometers from MRRH who are willing to participate in the study US National Institute of Health (Eunice Kennedy Shriver National Institute Of Child Health & Human Development of the National Institutes of Health) Medical and Health Sciences Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
 BREATHER Plus: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir- based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub-Saharan Africa, Version 2.0, Dated 18-Mar-2020; ISRCTN #: 85058577
REFNo: HS1822ES

Major Objective: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir-based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub- Saharan Africa
Specific Objectives
To evaluate an innovative and contemporary ART strategy in HIV-infected adolescents to provide choice for young people facing life-long treatment. Output from this RCT will provide evidence on efficacy, safety and acceptability of a novel treatment approach in HIV-infected adolescents in sub-Saharan Africa
To evaluate the virological efficacy, safety, acceptability and Quality of Life of DTG-based Short-cycle Therapy with weekends off compared with Continuous Therapy with a DTG- based ART regimen
To optimize treatment for HIV-infected adolescents in sub-Saharan Africa

 Kampala, Mulago
Wakiso, Seguku
 Uganda 2021-11-15 2024-11-15 460 HIV-infected, non-pregnant, non-breastfeeding adolescents aged 12 to 19 years of age, virologically-suppressed for at least one year, without any history of treatment failure, on 3-drug combination antiretroviral (ART) consisting of dolutegravir with a 2- University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership [RIA2017MC- 2005] Medical and Health Sciences Clinical Trial Non-degree Award
Namulema Edith
ID:
Effectiveness of the ‘LeVe CPAP’ against the standard AIRVO CPAP among Covid-19 patients with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A Cross-Over Randomised Trial.
REFNo: HS1647ES

The main objective of the trial is to compare the clinical effectiveness of the LeVe CPAP device to the standard AIRVO CPAP in the delivery and maintaining continuous positive airway pressures among patients diagnosed with AHRF at Mengo Hospital Uganda.
 Kampala, mengo
 Uganda 2021-10-28 2024-10-28 40 Male and Female Adult patients with evidence of acute hypoxaemic respiratory failure admitted at the CTU. Any Tribe. Leeds Teaching Hospital National Health Service Trust in the UK Medical and Health Sciences Clinical Trial Non-degree Award
Khamisi Musanje
ID: UNCST-2021-R012863
 Acceptability, Feasibility and Effectiveness of a Mindfulness based Intervention to Promote Adherence to Antiretroviral Therapy among Adolescents in Kampala.
REFNo: HS1656ES

1. To adapt and explore acceptability of ACT-DNA-v among users (ALWHA) and providers (HCPs).
2. To measure feasibility of the adapted ACT-DNA-v for use with ALWHA.
3. To examine the impact of ACT-DNA-v on reducing proximal psychosocial barriers to medication adherence (depression, anxiety and stigma) among ALWHA.
4. To measure effectiveness of a mindfulness based intervention (ACT-DNA-v) on self-reported adherence among ALWHA in Kampala, and ascertain its impact on viral load reduction via analysis of data from medical records

Kampala, Mutundwe
Kampala, Central
Uganda 2021-10-20 2024-10-20 116 Study will be conducted among older adolescents 14-19 years living with HIV attending care at either Kisenyi or Kitebi health centers. Both male and female will be considered. Behavioral social science research grant Medical and Health Sciences Clinical Trial Degree Award
Damalie Nalwanga
ID: UNCST-2021-R013217
 SEVERE PNEUMONIA IN CHILDREN: THE ABILITY OF BODY COMPOSITION TO PREDICT SURVIVAL, AND THE EFFECT OF NUTRITIONAL SUPPLEMENTATION ON OUTCOMES
REFNo: HS1719ES

4. To determine the effect of a nutritional intervention (RUTF) on clinical outcomes (post discharge mortality, re-admission, and occurrence of severe acute malnutrition) of children hospitalized for severe pneumonia.,3. To determine the effect of a nutritional intervention (RUTF) on fat and muscle mass in children hospitalised for severe pneumonia.,2. To compare the ability of various muscle and fat mass indices to predict survival in children hospitalised for severe pneumonia.,1. To describe the role of nutritional status on outcomes following hospitalization for severe pneumonia among children.,To describe the relationship between muscle and fat mass and survival, and determine the role of nutritional supplementation on fat and muscle mass, and on treatment outcomes of children hospitalized for severe pneumonia,
 ,
Jinja,
Mbale,
Soroti,
Uganda 2021-10-20 2024-10-20 450 Children aged 6 months to 12 years hospitalized for severe pneumonia. Self Sponsored Medical and Health Sciences Clinical Trial Degree Award
Susan Adakun
ID:
Comparing adherence to MDR-TB treatment among patients on self-administered therapy and those on Directly Observed Therapy: Non Inferiority Randomized Controlled Trial
REFNo: HS1796ES

Primary Objectives
1. To determine if adherence to MDR-TB treatment among patients on self-administered therapy (measured by Medication Events Monitoring System (MEMS) technology) is non-inferior to that among patients on Directly Observed Therapy (DOT)
Secondary objectives

1. To determine the correlation between serum MDR-TB drug concentrations and adherence as measured by MEMS technology


2. To compare treatment outcomes between MDR-TB patients on self-administered therapy and DOT

 Kampala, Mulago
Lira,
Mbarara,
Uganda 2021-10-20 2024-10-20 164 Age of study Population: 8 years and above Gender of study population: Both male and female Persons of any and all tribes are eligible for study participation as long as they fit the eligibility criteria Janssen Global Public Health, a division of Janssen Pharmaceutica NV, under grant number 1550786 Medical and Health Sciences Clinical Trial Non-degree Award
Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
 Uganda Paediatric and Adolescent HIV Cohort on Antiretroviral Therapy: Study Protocol (UP-ART)
REFNo: HS1699ES

The objectives of this study are to:
1) Describe the characteristics of children and adolescents living with HIV receiving paediatric care in the participating centres and coverage of ART
2) Describe the uptake of new antiretroviral drugs such as DTG across age groups and regions
3) Assess the effectiveness and safety of new antiretroviral drugs such as DTG, including viral suppression, incidence of adverse events, serious adverse events and discontinuation of drug
4) Assess broader clinical outcomes including retention in care, mortality, disease progression, immune response, viral suppression, overall and by age and treatment regimen/treatment history
5) Assess (i) the prevalence of HIV drug resistance among children/adolescents start of treatment and the impact on treatment response, and (ii) among those who experiencing virological failure on DTG to describe the risk of accumulation of drug resistance (see sub-study Section 4).

Hoima, Kahora Division
Lira, Lira
Wakiso, Wakiso
 Uganda 2021-10-14 2024-10-14 3000 All children/adolescents attending HIV care at the participating clinics will be invited to join the study the International AIDS Society, the World Health Organisation, University College London capacity strengthening grant and UNICEF (grant and in-kind support). Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 Youth Health SMS: Using mobile technology to prevent HIV and related Youth Health problems: Sexual health, Mental health, and Substance use in southwest Uganda
REFNo: SS969ES

This study will result in the development of one of the first mobile phone-based interventions for Adolescents and Young Adults (AYA) in East Africa that begins to address the co-morbid HIV risk factors of sexual health, mental health, and alcohol use. AYA is a developmental period associated with the increased importance of peers, increased technology use, increased mobility, initiation of sex, emergence of mental health disorders (if at risk), and initiation of alcohol use. Consequently, AYA is a critical time for preventive interventions. Poor mental health and alcohol abuse are associated with increased risk for HIV infection. Thus, the proposed research will attempt to address these areas concurrently.

The proposed research will evaluate if adapting and updating the existing free and nationally available text message and interactive voice recognition (IVR) service included in *161 that was initially developed by FHI 360. Our work will test and tailor messages for AYA to disseminate pre-exposure prophylaxis (PrEP) information and pilot specific mental health and hazardous alcohol use screens. Symptomatic AYA will be referred to behavioral health counselors for further assessment and treatment as needed. AYA today rely heavily on mobile phones for information and services, thus we believe the proposed intervention could be applied and adapted across the region, and potentially in other under-resourced settings.

We will conduct formative research to evaluate and adapt an existing text-message and interactive voice recognition (IVR) platform. We will then pilot the new menus and examine if using this platform promotes HIV prevention (pre-exposure prophylaxis (PrEP), HIV testing, safer sexual behaviors) and increases mental health and alcohol use screening and linkage to counselors as needed for adolescents and young adults (AYA) in a rural Ugandan region with high HIV seroprevalence and limited resources.

2. State the study objective(s) and research question(s)
Aim 1: To adapt an evidence-based mobile phone-delivered sexual health program, to include PrEP information and deliver mental health and alcohol use assessments with the goal of increasing screening and referral, as well as linkage to counselors for AYA at HIV risk.

Aim 2: Evaluate through a pilot RCT (N=126 AYA, 15-19 years) intervention (a) acceptability and feasibility, and (b) impact on uptake of HIV prevention strategies, as well as screening and linkage to mental health and alcohol use school-based counselors.

 Masaka, Kimaanya
Kalungu, Kabukunge
 Uganda 2021-10-12 2024-10-12 164 There will be two phases to the study. The first will be approximately three months and include 24 male and female AYA (15-19) years. The second phase will include 140 male and female (15-19 years). National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
Christine  Wiltshire Sekaggya
ID: UNCST-2019-R000578
 Clinical Predictors of 3-Months Isoniazid Rifapentine (3HP)- Related Adverse Drug Reactions (ADR) During Tuberculosis Preventive Therapy (PAnDoRA-3HP study)
REFNo: HS1582ES

Primary Objectives
1.To describe the safety profile of 3HP among people receiving tuberculosis preventive therapy.
2.To describe the effect of adverse drug reactions on tuberculosis preventive therapy completion rates
Secondary Objective
1.To describe the pharmacokinetic and pharmacogenomic determinants of ADRs among people receiving tuberculosis preventive therapy in Uganda
2.To determine the efficacy of 3HP when used for tuberculosis preventive therapy.

 Kampala, Mulago III
Kampala, Kisenyi
Kampala, Kasubi
Kampala, Nakawa I
Jinja, Magwa
Mubende, Mubende Town Council
 Uganda 2021-10-04 2024-10-04 614 Patients will be included in the study if they meet the following inclusion criteria: 1. Individuals of any age who have been initiated on TPT using the isoniazid/rifapentine regimen according to standard of care 2. Both PLWHIV and HIV-uninfected indivi National Institution of Health Medical and Health Sciences Clinical Trial Non-degree Award
Joseph Lutaakome
ID: UNCST-2020-R008323
 An International Multicenter, Randomized, Double-Blind, PlaceboControlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
REFNo: HS1715ES

Primary Objective
Primary objective: Among outpatients with recently diagnosed SARS-CoV-2 infection to compare the safety and efficacy of a single infusion of hIVIG (pooled for the 2 hIVIG

products) versus placebo, each given with SOC, on clinical status after seven days. Two hypotheses will be tested to address this primary objective, which compares the primary endpoint among two study populations: 1) participants where neutralizing MAb was not specified as part of SOC treatment (stratum 1, see Section 6.1 Overall Study Design); and 2) all randomized participants (stratum 1 and stratum 2 combined). hIVIG will be considered superior to placebo if either of the two hypotheses are rejected.
Secondary Objectives and Endpoints
Secondary objectives, including subgroup analyses and safety outcomes, will be addressed for all randomized participants and for those in stratum 1 and 2 separately.
Secondary Endpoints
The clinical status as classified on the ordinal outcome scale will be assessed with a number of additional analyses comparing hIVIG (pooled for the 2 hIVIG products) with placebo, among the overall study population as well as for the key subgroup of those not receiving anti-SARS-CoV-2 monoclonal antibodies as part of SOC (stratum 1), including:
1. All-cause hospitalization or death through 28 days.
2. All-cause mortality through 28 days.
3. Significant disease progression through 28 days, using a time to event analysis with outcome defined by fulfilling criteria for category 4 or 5 on the ordinal scale.
4. Distribution of ordinal scale outcome at Day 4, 14, and 28.
5. The proportion of participants with any disease progression at Day 7, using a sliding dichotomous scale progression defined by a categorization on the ordinal scale that is worse than the status at entry

 Uganda 2021-10-04 2024-10-04 A sample size for this phase 3 trial of 820 participants is planned, which would consist of at least 656 participants in stratum 1. In order to be eligible to participate in this study, a patient must meet all of the following inclusion criteria prior to randomization: i. Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an ii. immunosuppressed condition. The study is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, through their contract organization Leidos. There is a subcontract between the University of Minnesota (the Sponsor) and the MRC CTU at UCL. Medical and Health Sciences Clinical Trial Non-degree Award
Lukia Namaganda Hamid
ID:
Malnutrition as a probable predictor of mortality in cerebral palsy (CP), and the effect of positive deviance and parent facilitator training strategies to malnutrition and caregiving among children and adolescents with CP in the Iganga, Mayuge and Bugweri rural districts of eastern Uganda
REFNo: HS1427ES

Specific Objectives:
1. To assess mortality and whether malnutrition is one of the predictors among a population based sample of children and adolescents with cerebral palsy the Iganga Mayuge-Health and Demographic Surveillance Site (IM-HDSS), Uganda
2. To assess the difference in the change in nutritional status in 2015 and 2019 among children with CP compared to their age and sex matched controls without CP at the IM-HDSS, Uganda.
3. To explore positive and negative nutrition practices among caregivers of well-nourished and under-nourished children with cerebral palsy respectively at the IM-HDSS, Uganda.
4. To determine the difference in the effectiveness of the positive deviance strategy and parent facilitator trainings on CP child and adolescent malnutrition and caregiving within the Iganga, Mayuge and Bugweri districts, Uganda.

 Iganga,
Mayuge,
Uganda 2021-09-29 2024-09-29 126 for the RCT Caregivers of children and adolscents with Cerebral aged 2-21 years old Cerebral Palsy in Uganda Project (CURIE), Makerere University School of Public Health, Department of Epidemiology and Biostatistics Medical and Health Sciences Clinical Trial Degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 Evaluation of the performance of the Salmonella Biolineâ„¢ typhi IgG/IgM Fast test in a near-patient testing environment, including evaluation of usability
REFNo: HS1700ES

To evaluate the usability of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in the near-patient environment using a questionnaire based survey. ,To establish the performance of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in a near-patient setting compared to the performance in a professional lab (i.e. Central Public Health Laboratory) using venous whole blood samples. ,
 pakwach,
Kampala, Kiruddu
Kampala, kisenyi
 Uganda 2021-09-29 2024-09-29 80 • Male and female patients above 18 years seeking treatment from selected health units who are able to give consent to the study meeting the selection criteria. ABBOTT KOREA Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 COMPARISON OF PERFORMANCE OF CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA TEST DEVICE/ TEST REF: ISY-U402 AND CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA RAPID TEST STRIP) REF: ISY-U401 USING SD BIOLINE VERSION 3.0 AS A REFERENCE
REFNo: HS1643ES

The objective of this evaluation is to demonstrate the equivalence of capillary (fingerprick) whole blood and venous whole blood on the Syphilis Ultra test device/ Test strip (Whole Blood/Serum/ Plasma) and strip.
2.4 Exploratory Objectives
• To determine the diagnostic accuracy of the Syphilis Ultra test device/ Test (Whole Blood/Serum/ Plasma) and strip.

 Kampala, Naguru
 Uganda 2021-09-23 2024-09-23 100 3.1 Subject Population Patients attending the Sexually Transmitted Diseases clinic (STD) at China Friendship Regional referral Hospital Uganda will be enrolled for the study. Patients attending this clinic are referrals from other units presenting with s Ministry of Health Medical and Health Sciences Clinical Trial Non-degree Award
Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
 Transitioning children to Optimal Regimens of Paediatric Dolutegravir (TORPEDO) in Uganda
REFNo: HS1596ES

the primary objective for the study is to assess patients’/ caregivers’ preference for a paediatric DTG regimen over their previous regimen, when transitioned from another regimen.

 Hoima, Kahora Division
Wakiso, Wkiso
Lira, Lira city
Buikwe, Buikwe
Mayuge, Mayuge
Kampala, Kampala
 Uganda 2021-09-22 2024-09-22 approximately 4,000 children and adolescents 0-19 years Clinton Health Access Initiative Medical and Health Sciences Clinical Trial Non-degree Award
ELIZABETH NALINTYA
ID: UNCST-2021-R012882
 Long title: A community-based Phase III, cluster randomized trial of point-of-care CD4 testing and enhanced screening and prophylaxis in advanced HIV disease Short title: An enhanced package of care to reduce mortality in advanced HIV disease
REFNo: HS1605ES

Primary Objectives:
1. To assess 24-week survival with retention in care in persons with advanced HIV disease (CD4<200 cells/µL) with point-of-care CD4 testing compared to standard flow cytometry
2. To assess 24-week survival with retention in care with an enhanced diagnostic OI screening and prophylaxis strategy compared to standard WHO package of care in persons with advanced HIV disease
Secondary Objectives:
1. To determine incidence of OIs
2. To measure adverse events with enhanced prophylaxis regimens
3. To assess tolerability and adherence of enhanced prophylaxis regimens
4. To determine incidence and cause of hospitalization for persons with advanced HIV disease
5. To determine cause of death for persons with advanced HIV disease
6. To determine HIV outcomes of viral suppression in persons with advanced HIV disease.
7. Measure cost, cost-effectiveness, and budgetary impact of the CD4 testing strategies, and OI screening and prophylaxis strategies.

 Kampala,
Wakiso,
Uganda 2021-09-21 2024-09-21 2400 • Age >18 years • CD4<200 cells/µL • Ability and willingness to give informed consent for the enhanced package of care arm. INFECTIOUS DISEASES INSTITUTE Medical and Health Sciences Clinical Trial Non-degree Award
Achilles Katamba
ID: UNCST-2019-R000540
 Human-Centred Design and Communities of Practice to Improve Delivery of Home based Tuberculosis Contact Investigation in Uganda
REFNo: HS1720ES

General Objective: The study aims to assess the effectiveness of an enhanced intervention strategy for implementing TB contact investigation relative to usual care. Specific Objectives: 1.To compare the implementation, effectiveness, and public health impact of TB contact investigation delivered via an enhanced intervention strategy vs. the usual care strategy in a stepped-wedge, cluster-randomized implementation trial. 2.To identify implementation processes and contextual factors that influence the effectiveness of the intervention strategy for TB contact investigation. 3.To compare the costs and epidemiological impact of the intervention and usual care strategies for TB contact investigation.
Masaka, Ndejje
Masaka, Masaka
Butambala, Goombe
Wakiso, Wakiso
Wakiso, Ndejje
Kiboga, Kiboga
Mubende, Kasambya
Mubende, Mubende
Mityana, Mityana
Iganga, Iganga
Bugiri, Bugiri
Jinja, Jinja
Wakiso, Entebbe
Wakiso, Kasangati
Kayunga, Kayunga
Kayunga, Nagalama
 Uganda 2021-09-17 2024-09-17 1764 household and close contacts within approximately 2304 eligible index patient clusters over a 16-month period. Household and close contacts of index patients with active pulmonary TB National Institute of Allergy and Infectious Diseases (NIAID) Medical and Health Sciences Clinical Trial Non-degree Award
Martha Musyoka Mbenia
ID:
PREDICTORS OF ADVERSE FETO-MATERNAL OUTCOMES AMONG MOTHERS ADMITTED WITH ANTEPARTUM HEMORRHAGE AT MBARARA REGIONAL REFERRAL HOSPITAL
REFNo: HS1450ES

To describe adverse outcomes and determine predictors of adverse feto-maternal outcomes in mothers with antepartum hemorrhage at Mbarara Regional Referral Hospital
 Mbarara, Mbarara
 Kenya 2021-09-09 2024-09-09 107 All women of childbearing age presenting with antepartum hemorrhage at Mbarara Regional Referral Hospital Self. No conflict of interest anticipated Medical and Health Sciences Clinical Trial Degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
 PERFORMANCE EVALUATION OF COVID-19 ANTIGEN RAPID DIAGNOSTIC TESTS
REFNo: HS1690ES

To determine the association of positive index test results with disease stage (days since symptom onset, e.g. acute, early, late), symptom severity and symptom severity.,To determine the diagnostic accuracy of SARS-CoV-2 Ag RDTs on a respiratory specimen (NP swab, OP swab, nasal swab, saliva), vs Cobas SARS-CoV-2 assay as performed in patients presenting with influenza-like illness.,
 pakwach,
Kampala, Mulag0
Kampala, Kiruddu
Masaka, Masaka
Mbarara, Mbarara
 Uganda 2021-09-08 2024-09-08 5000 • Suspected COVID-19 cases ≥ 18 years of age presenting with symptoms at selected reginal and national referral hospitals in Uganda, will be enrolled for the study. These sites were chosen because they are the regional referral hospitals and register FIND, the global alliance for diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A clinical trial to assess the safety and immunogenicity of LNP-nCOV saRNA-02, a self-amplifying ribonucleic acid (saRNA) vaccine encoding the S glycoprotein of SARS-CoV-2, the causative agent of COVID-19, in SARS-CoV-2 seronegative and seropositive Uganda population
REFNo: HS1641ES

Primary Objective:

• To compare the safety and immune responses for SARS-CoV-2 seronegative and seropositive individuals from two immunisations with LNP-nCOV saRNA-02 administered IM 4 weeks apart at one dose level in 42 participants age 18-45 years.

Exploratory Objectives:
• To characterise the humoral and cellular immune responses to LNP-nCOV saRNA-02 administered at one dose given at 0 weeks and 4 weeks for individuals seronegative and seropositive for SARS-CoV-2 antibodies
• To characterise the profile of class and sub-class of antibody responses
• To characterize infection induced immune responses in participants with naturally acquired infection who are also exposed to the vaccine

 Masaka, Butego
 Uganda 2021-09-08 2024-09-08 42 The study will be conducted in healthy young adults as these individuals generate the most robust responses (18-45 years). Both male and female participants will be included and the trial site will attempt to keep an equal proportion, although the priorit The study is sponsored by Imperial College London, funded by the United Kingdom Engineering and Physical Sciences Research Council. Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A behavioural Science Research to Determine Factors that Facilitate Future Uptake of HIV Prevention Products and Multi-Purpose Prevention Technologies to Prevent HIV and Unwanted Pregnancy in Sub-Saharan Africa Universally Accessible HIV Prevention Technologies for African Girls and Young Women through Knowledge Applied from Behavioural Economics (UPTAKE)
REFNo: HS1540ES

Multi-purpose Prevention Technologies (MPTs) to prevent HIV and unwanted pregnancy in Sub-Saharan Africa

i. To understand facilitators of and barriers to uptake and retention of injectable and implantable long acting pre-exposure prophylaxis (LA-PrEP) and MPT to inform product development, using formative behavioural research methods
ii. To design interventions to impact the uptake of new biomedical HIV prevention products, as part of a suite of self-care and self-screening products for sexual and reproductive health, using quantitative behavioural research methods
iii. To test the effectiveness of the alternate design/interventions and strategies, using marketed LA contraceptive products as proxies for LA HIV prevention products in development
iv. To estimate the cost of retention interventions and the cost effectiveness of products and delivery methods among adolescent girls and young women (AGYW) and female sex workers (FSWs) for prevention of pregnancy and/or HIV, using modelling

 Kampala, NOT APPLICABLE
 Uganda 2021-08-31 2024-08-31 1190 Adolescent Girls and Young Women (AGYW) aged 15 to 24 years and Female Sex Workers (FSW) aged 15 to 45 years, Health Care Providers (HCP), and Policy Makers (PM) in Kampala, Uganda and Nairobi, Kenya. Study Size and duration: Stage 1: 30 AGYW, 30 FSW, 10 International AIDS Vaccine Initiative, The Address, 11th Floor, Muthangari Drive, Nairobi, Kenya; T:+254.719.043.000 Medical and Health Sciences Clinical Trial Non-degree Award
BRENDA GATI MIREMBE
ID: UNCST-2021-R013390
 A Phase 3, Randomized, Active Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Women at High Risk for HIV 1 Infection.
REFNo: HS1631ES

Primary Objectives:
1. To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the
prevention of HIV-1 infection as assessed by the incidence rate per year of confirmed
HIV-1 infection.

2. To evaluate the safety and tolerability of oral ISL QM compared to oral FTC/TDF QD as assessed by review of the accumulated safety data

Secondary Objective
1. To evaluate the efficacy of oral ISL QM in reducing the incidence per year of HIV-1
infection relative to the background rate.

 Kampala,
Wakiso,
Mukono,
Mpigi,
Nakaseke,
Luweero,
Buikwe,
Jinja,
Gomba,
Butambala,
Kayunga,
Uganda 2021-08-27 2024-08-27 Approximately 4,500 participants will be randomized (stratified by site and age) in a 1:1 ratio to receive either ISL or FTC/TDF for the duration of the study. Approximately 50% of the global study po Cisgender female participants aged 16 to 45 years of age who are at high risk of acquiring HIV-1 infection. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Jayne Ellis
ID: UNCST-2021-R013987
 “Integrated management of cryptococcal and opportunistic infections to improve outcomes in advanced HIV disease (IMPROVE study)”
REFNo: HS1607ES

1) To generate evidence on the safety (adverse events) and feasibility (adherence and tolerability) of 1HP (one month of isoniazid and rifapentine) for TB preventative therapy (TPT) amongst adults with HIV-associated cryptococcal meningitis.
2) To generate preliminary data on potential secondary benefits (reduced loss to follow-up, reduced active TB disease, reduced mortality due to TB) of early (inpatient initiation) 1HP TPT as compared to standard (outpatient initiation) 1HP TPT amongst adults with HIV-associated cryptococcal meningitis.

Kampala, Salaama
Mbarara, Mbarara
 UK 2021-08-25 2024-08-25 205 Adults (>18 years) with HIV-associated cryptococcal meningitis London School Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
 CoVPN 3008- UBUNTU Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Version 1.0, dated 16 May 2021. DAIDS Document ID # 38838.
REFNo: HS1642ES

Primary Objectives
The primary objectives of this study are to determine the following:
1. To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
2. To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
3. To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

Secondary Objectives
The secondary objectives of this study are to evaluate the following:
1. Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
2. VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
3. VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
4. VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
5. Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
6. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status

Exploratory Objectives
The exploratory objectives of this study are to evaluate the following:
1. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
2. VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
3. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
4. Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
5. Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
6. Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial

 Kampala, Mulago
Kampala, Kawaala
Kampala, Wankuluku
Kampala, Kisenyi
Kampala, Kisugu
Kampala, Kisugu
 Uganda 2021-08-24 2024-08-24 125 This study will be conducted in regions and populations where new more resistant variants of SARS-CoV-2 are highly prevalent. Prevalence of the new variants is known to result in reinfections, suggesting that a prior infection with the SARS-CoV-2 ancestra The study is sponsored by the South African Medical Research Council (SAMRC) and funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institute of Health (NlH) of the United States of America. Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Kiguba
ID: UNCST-2019-R000844
 Two-way risk communication mobile application use versus traditional methods of adverse drug reaction reporting in Uganda: a cluster-randomized controlled trial
REFNo: HS1366ES

This study will: i) assess the feasibility of implementing a mobile app for the reporting of ADRs associated with DTG and IPT at selected ART-sites in Uganda; ii) describe the characteristics (causality, seriousness, completeness, unexpectedness, severity, outcome) of the DTG- and IPT-linked ADR-reports submitted to NPC using the mobile app; and, iii) determine if use of the mobile app versus existing methods of ADR-reporting (paper-form and web-form) increases by 25% the number of reported ADRs linked to DTG and IPT use during 2.5 years of follow-up, iv) determine the cost and cost-effectiveness of using the mobile app versus existing methods of ADR-reporting.
 Wakiso, Seguku
 Uganda 2021-08-20 2024-08-20 382 Antiretroviral Sites across Uganda The mobile app will be introduced nationwide at 382 high-volume accredited antiretroviral therapy (ART)-sites where MoH implemented the scale up of IPT. These pre-selected ART-sites hold 80% of the patients on ART in Uganda. All HCPs at the pre-selected A Makerere University Research & Innovations Fund Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.
REFNo: HS1669ES

-To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent
virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in
adults who are at risk of severe COVID-19 -2. To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19 -3. To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19
Wakiso, Ssabagabo
 Uganda 2021-08-20 2024-08-20 14,000 age ≥ 40 and at least one comorbidity known to be associated with severe COVID-19, 2) age ≥ 18 and pregnant, 3) age ≥ 18 and HIV-infected. South African Medical Research Council (SAMRC) Cape Town, South Africa. Medical and Health Sciences Clinical Trial Non-degree Award
Philippa Musoke
ID: UNCST-2021-R013523
 ViiV 205858: Open-label access to dolutegravir for HIV-1 infected children and adolescents completing IMPAACT Studies P1093 and P2019 Version 4.0 dated 10 Dec 2020
REFNo: HS1453ES

Primary
• To provide access to age appropriate formulations of dolutegravir (DTG), either as single entity DTG or as fixed dose combination (FDC) abacavir/dolutegravir/lamivudine (ABC/DTG/3TC), in an open-label protocol to eligible participant s who have completed the P1093 or P2019 parent studies.

Secondary

To assess any serious adverse events (SAEs) and any clinical or laboratory adverse events that lead to the discontinuation of IP (DTG or ABC/DTG/3TC FDC).
 Kampala, Mulago
 Uganda 2021-08-20 2024-08-20 3 participants previously enrolled in P1093 at the MU-JHU Site Children aged 0-18 years who are formeerly participants in P1093 study at MU-JHU Site, both male and female and of any tribe as long as their caretakers/parents understand the language of consent. ViiV Health care Company Medical and Health Sciences Clinical Trial Non-degree Award
Deo Wabwire Ogema
ID: UNCST-2021-R013932
 COVPN 3008: Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Version 1.0 16 May 2021
REFNo: HS1659ES

The primary objectives are:
•To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
•To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
•To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

Secondary objectives are to evaluate the following:
•Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
•VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
•Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)
The exploratory objectives are to evaluate:
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
•VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
•VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
•Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
•Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
•Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial

 Kampala, Mulago 1
 Uganda 2021-08-20 2024-08-20 14,000 across all sites, about 500 from Uganda The study population will include 1.Adults aged 40 years or more with at least one co-morbid factor associated with severe COVID 19 2.People living with HIV who are 18 years and above Pregnant women aged 18 years and above South African Medical Research Council (SAMRC) Medical and Health Sciences Clinical Trial Non-degree Award
Annet Nanvubya
ID: UNCST-2025-R015525
 Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern version 1.0 16-05-2021.
REFNo: HS1677ES

Primary Objectives
The primary objectives of this study are to determine the following:
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
• To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

Secondary Objectives

The secondary objectives of this study are to evaluate the following:
• Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
• Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)

Exploratory Objectives
The exploratory objectives of this study are to:
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
• Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
• Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
• Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial


 Wakiso, Division A and B
 Uganda 2021-08-20 2024-08-20 14,000 This study will enroll participants who meet one or more of the following criteria: 1) Age > 40, who have at least one comorbidity known to be associated with severe COVID-19, 2) women age 18 years or older who are pregnant, and 3) HIV-1-infected indiv South African Medical Research Council(SAMRC) Cape Town, South Africa Medical and Health Sciences Clinical Trial Non-degree Award
Eun Seok Kim
ID:
Cross-sectional prevalence study of schistosomiasis and soil-transmitted helminthiasis with nested open-label randomised controlled study of evaluating the impact of fatty meal co-administration and double-dosing on albendazole effectiveness against hookworm infection among school-aged children in Mayuge district: Implications for Mayuge NTDs Elimination (MANE) Project
REFNo: HS1411ES

Objective 1: To determine the effect of albendazole administration with a fatty meal such as avocado, versus albendazole administration without a fatty meal, on hookworm cure rate and egg reduction rate.

Objective 2: To determine the effectiveness of dual-dose (400mg/day, two consecutive days) versus single-dose (400mg) albendazole treatment regimens on hookworm cure rate and egg reduction rate.

Objective 3: To identify and evaluate environmental, social and cultural variables affecting hookworm infection, and cure rate and egg reduction rate of albendazole against hookworm.

 Mayuge, All parish
,
South Korea 2021-08-16 2024-08-16 1650 Age: P4 and P5 grade students (approximately 9-10 years old) Sex: an approximately equal number of both male and female Korea International Cooperation Agency (KOICA) Medical and Health Sciences Clinical Trial Degree Award
Violet Korutaro
ID: UNCST-2019-R000618
 IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Short title: ‘MOCHA’ (More Options for Children and Adolescents), DAIDS # 30070, IND # 138,754
REFNo: HS1512ES

To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents,To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents by evaluating: Safety and multiple dose PK of oral CAB through Week 4, Safety and multiple dose PK of CAB LA through Week 16, and to confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16,To confirm the dose and evaluate the safety, tolerability, acceptability, and pharmacokinetics (PK) of oral cabotegravir (CAB), long-acting injectable cabotegravir (CAB LA), and long-acting injectable rilpivirine (RPV LA) in virologically suppressed HIV‐1 infected children and adolescents aged 12 to <18 years.,
 Kampala, Kisenyi
Kampala, Mulago
Kampala, Kawaala
Kampala, Naguru
Kampala, Kitebi
 Uganda 2021-08-16 2024-08-16 155 This study will be conducted in Kampala among HIV‐1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral. These potential partic National Institute of Allergy and Infectious Diseases Medical and Health Sciences Clinical Trial Non-degree Award
Jonathan Kayondo
ID: UNCST-2021-R008325
 Multi-Centre, Prospective, Evaluation for Matrix equivalence of capillary whole blood finger-stick and fresh and frozen venous whole blood with the NxTekâ„¢ Malaria Pf Plus Rapid Test Device and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test Device for the Detection of Plasmodium Infections in Patients with Symptoms Suggestive of Malaria within the Lab and its intended use environment for CE IVDR.
REFNo: HS1587ES

This trial is part of the R&D Verification and Validation studies, to provide clinical matrix equivalence evaluation to support the conformity assessment procedure for the use of fingerstick and venous whole blood samples with Abbott’s NxTek™ Malaria Pf Plus and NxTek™ Malaria Pf/Pv Plus Rapid Test Devices, as performed by professional users, in accordance with WHO PQ TSS-3, WHO PQ Dossier, EU 2017/7461.

Primary Objective: Matrix Equivalence
To assess the matrix equivalence of:
a. Fresh CWBFS and Fresh VWB
b. Frozen VWB and Fresh VWB
when used with the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus by laboratory professionals (from hereon referred to as Lab operators) in a laboratory environment to support CE IVDR certification.

The test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using a VWB sample, will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using CWBFS sample from the same participant. In summary: Fresh CWBFS vs. Fresh VWB*. Likewise, the test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using VWB samples that have been exposed to 1x Freeze/Thaw cycle will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using fresh VWB samples from the same participant. In summary: Frozen VWB vs. Fresh VWB*

*indicates: Where Fresh VWB will be the comparator sample type.

The data obtained will be used in the application for CE IVDR certification and WHO PQ. Paired CWBFS and VWB samples will be taken from the same individuals for testing on both NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus RDTs.

Secondary Objective: Intended Users within the Intended Use Environment
Malaria RDTs are used outside of the laboratory for near patient testing (NPT)* by non laboratory healthcare workers with limited training. Thus the secondary objective of this study is to assess the perfromance of the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus results when used in its intended environment (NPT setting) by intended users (non laboratory healthcare workers with limited training) using CWBFS as the sample type.*see NPT definition Section 4.2-4.3 of protocol (or below sections on trial operator types and trial envitronment types).

 Kanungu, Market Cell
Wakiso, Maganjo
Wakiso, Central Ward
 Uganda 2021-08-16 2024-08-16 Section 5.2 of Protocol: Two arms- each kit minimum 90 Pf Positives, 26 Pv Positives, 116 Negatives All comers, febrile symptomatic patients of both sexes aged 15 years and above suspected of having malaria and seeking standard medical care at the sites. Abbott Diagnostics Korea Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Rhoda Wanyenze
ID: UNCST-2021-R013352
 PILOT OF A NETWORK-DRIVEN, ADVOCACY INTERVENTION TO PROMOTE CERVICAL CANCER SCREENING IN UGANDA (PHASE 3)
REFNo: HS1633ES

The proposed intervention development study seeks to improve cervical cancer screening in Uganda by engaging and training local public health researchers and program implementers, and empowering women living with cervical cancer risk (WLCCR), defined as women who have ever received CC screening procedures, to advocate for CC screening and early treatment among women in their social networks.
 Namayingo, Buyinja
 Uganda 2021-08-16 2024-08-16 40 index participants; 120 social network members This study represents phase 3 of the study that was earlier registered with UNCST. During this phase, we will aim to enroll women living with cervical cancer risk (hereafter referred to as the 'index participants'), defined as women who have ever been scr Glenn Wagner (RAND Corporation, USA) Medical and Health Sciences Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
 IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Version 3.0, dated 13 August 2020
REFNo: HS1356ES

Primary Objectives:
Cohort 1
1.To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents
2.To confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16
Cohort 2:
1.To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents
Secondary Objectives: Cohort 1
• To monitor maintenance of viral suppression through Week 16 in HIV-infected, virologically suppressed adolescents
• To evaluate the tolerability and acceptability of CAB LA through Week 16 in HIV-infected,virologically suppressed adolescents
• To evaluate the tolerability and acceptability of RPV LA through Week 16 in HIV-infected,virologically suppressed adolescents
Secondary Objectives: Cohort 2
• To assess safety of oral CAB + oral RPV followed by CAB LA + RPV LA through Week 48 in HIVinfected, virologically suppressed adolescents
• To evaluate repeat-dose pharmacokinetics of CAB LA + RPV LA through Week 24, and through
Week 48 in HIV-infected, virologically suppressed adolescents.
• To assess antiviral activity of CAB LA + RPV
 Kampala, Mulago
Kampala, Mulago 1
 Uganda 2021-08-11 2024-08-11 155 participants overall but MUJHU plans to enroll 18-25 participants HIV‐1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, National Institutes Of Health Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Performance Evaluation of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in Uganda
REFNo: HS1606ES

Main objective
To evaluate the field performance of the m-PIMATM HIV-1/2 VL plasma VL in identifying virological failure (VF) in adults on ART. The performance will be compared to standard PCR assays used at UNHLs and UVRI.
2.3.2 Primary objectives
I). To evaluate the diagnostic accuracy using the sensitivity, specificity, NPV, PPV, FPR and FNR of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in comparison to a reference assay of HIV-1 RNA PCR in identifying HIV-VF at the WHO recommended threshold of 1000 copies/ml for HIV-1 infected.
II). To determine the operational characteristics of the m-PIMAâ„¢ HIV-1/2 VL plasma assay, such as ease of-use of the assay using the standardized system usability scale (SUS) by laboratory and no laboratory personnel
III). To determine changes in turn-around time and ease of clinic workflow integration.
IV).To determine acceptability of the m-PIMAâ„¢ HIV-1/2 VL plasma assay by the study participants

 Kampala, Kampala
Buikwe, Buikwe
Kayunga, Kayunga
Mpigi, Mpigi Town Council
 Uganda 2021-08-11 2024-08-11 403 participants -Adult ART patients who are ≥18 years old on ART for ≥ 6 months will be approached for study participation. Historical controls will be used to compare the time to initiation of intensive adherence counselling (IAC) between the m-PIMA and the standard - Abott Diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Hannah Kibuuka
ID: UNCST-2020-R014355
 A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older
REFNo: HS1638ES

1. To assess, in participants who are SARS-CoV-2 naïve, the
clinical efficacy of the CoV2 preS dTM-AS03 vaccines for
the prevention of symptomatic COVID-19 occurring ≥ 14
days after the second injection.

2. To assess the safety of the CoV2 preS dTM-AS03 vaccines
compared to placebo throughout the study.
 Kampala,
Wakiso,
Mukono,
Uganda 2021-08-10 2024-08-10 800 Adults 18 years of age and older Sanofi Pasteur Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 An open label, Phase 2 study to evaluate the safety and immunogenicity of an Ad26.ZEBOV booster dose in Human Immunodeficiency Virus Positive (HIV+) adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen
REFNo: HS1350ES

• To assess the safety and tolerability of a Ad26.ZEBOV booster dose in HIV positive adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen.

• To assess humoral responses induced by the booster dose against EBOV glycoprotein (GP), as measured by Filovirus Animal Non-Clinical Group (FANG) Enzyme-Linked Immunosorbent Assay (ELISA) at 7 and 21 days.

 Masaka, NOT APPLICABLE
Lwengo, NOT APPLICABLE
Bukomansimbi, NOT APPLICABLE
Kalungu, NOT APPLICABLE
 Uganda 2021-08-04 2024-08-04 50 participants Participants must be healthy (based on physical examination, medical history, and clinical judgment) HIV positive adults who received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in the VAC52150EBL2002 trial and were aged ≥18 to ≤50 years at the tim London School of Hygiene & Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
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