Yerusa Kiirya
ID:
|
Acceptability, Feasibility and Effectiveness of a WhatsApp peer support group as a strategy to improve antiretroviral therapy adherence among youth in Kampala District
REFNo: SIR170ES
To determine the effectiveness of a WhatsApp peer support group combined with the standard of care in improving ART adherence among YLHIVA aged 15-24 years in Kampala district.,To determine the effect of a WhatsApp peer support group combined with the standard of care on psychosocial barriers to ART adherence and retention in care among YLHIVA aged 15-24 years in Kampala district.,To assess the feasibility of using a WhatsApp peer support group combined with the standard of care as an ART adherence and retention in care strategy among YLHIVA aged 15-24 years, To asses the acceptability of a WhatsApp peer support group combined with the standard of care as an ART adherence and retention in care strategy among YLHIVA aged 15-24 in Kampala district.,To assess the acceptability, feasibility and effectiveness of a WhatsApp peer support group combined with current standard care as a strategy to improve ART adherence among YLHIVA in Kampala.,
|
Kampala, Kiswa
Kampala, Komambogo
Kampala, Kawala
|
Uganda |
2023-01-20 14:23:51 |
2026-01-20 |
488 |
This study will be conducted among YLHIVA aged 15-24 years currently receiving ART services at
Kiswa, Komambogo and Kawala HCIII with an
ART adherence score of less than 95% within the past 12 months |
Strengthening behavioral and social science research capacity to address evolving challenges in HIV care and prevention in Uganda. |
Engineering and Technology |
Clinical Trial |
Degree Award |
|
Winnie Muyindike R
ID: UNCST-2021-R013558
|
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) – “Promoting Treatment as Prevention”
REFNo: HS2622ES
2. To assess the impact of gabapentin compared to placebo on: a) alcohol consumption; b) pain severity; c) ART adherence; and d) engagement in HIV care, in order to explore potential mechanisms by which gabapentin may lead to HVL suppression.,1. To test the efficacy of gabapentin versus placebo to achieve undetectable HVL (Primary Outcome at 3 months; Secondary Outcome at 6 & 12 months),
|
Mbarara, Kamukuzi
Mbarara, Kakoba
|
Uganda |
2023-01-18 18:33:54 |
2026-01-18 |
300 |
18 years and above, female and male, irrespective of tribe, who are on antiretroviral therapy with detectable viral load and are unhealthy alcohol consumers. |
National Institute of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Isaac Ssewanyana
ID: UNCST-2020-R014336
|
Evaluation of the performance of novel molecular point of care diagnostics for SARS-CoV-2
REFNo: HS2588ES
To assess the ease of use of the molecular POC devices being evaluated using a System Usability Scale (SUS) questionnaire administered to platform’s operators (minimum 3, where possible)., To evaluate the diagnostic accuracy of such platforms in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RTPCR in specific subgroups defined based on disease stage (days since symptoms onset), RTPCR Ct values (as surrogate for viral load). Participant’s vaccination status, previous COVID-19 infection(s) and SARS-CoV-2 genetic variant causing participant’s infection, determined by sequencing of the viral genome, may also be considered as subgroups. , To evaluate the diagnostic accuracy of molecular POC devices in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RT-PCR (WHO EUL or FDA EUA approved), among COVID-19 symptomatic individuals,
|
Kampala, Mulago
Kampala, Kiruddu
Kampala, Kawempe
Kampala, Butabika
|
Uganda |
2023-01-18 18:21:06 |
2026-01-18 |
200 |
The study will focus on adults with symptoms compatible with COVID-19 (and/or specimens collected from them) attending healthcare facilities in Uganda.
If a participant is screened and enrolled but is not able to provide the specimens required for the study, this participant will be withdrawn. |
FIND GENEVA |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Raymond Tweheyo
ID: UNCST-2020-R014507
|
Evaluating the pilot of the Community Health Extension Worker (CHEW) strategy in Uganda: assessing feasibility, and effectiveness for improving Village Health Team (VHT) supervision and reporting
REFNo: HS2545ES
General Objective
To explore the acceptability, document the implementation process and evaluate the effectiveness of the Community Health Extension Worker strategy in two districts of Uganda to guide improving the community health system
Specific Objectives
1) To assess the acceptability of introducing a Community Health Extension Worker (CHEW) strategy in a district health system.
2)To document the process of setting up and implementing a Community Health Extension
Worker (CHEW) strategy within a district health system.
3) To estimate the program costs and duration for setting up a government-led Community Health Extension Worker (CHEW) strategy within a district health system.
4) To determine the effectiveness of the CHEW strategy for improving the quality of Village Health Team (VHT) member’s supervision and reporting in a district health system.
5) To assess the effect of the CHEW strategy on community-level indicators: completion of four antenatal care visits, skilled delivery attendance, fully immunized under-fives, and U5 sick children seen by VHTs and treated within 24 hours.
|
Mayuge, all parishes
Lira, all parishes
Kabarole, all parishes
Kyotera, all parishes
|
UK |
2023-01-03 13:08:01 |
2026-01-03 |
3,016 women of reproductive age |
1) Household members: Adult women of reproductive age 18 to 49 years.
2) Community health workers - 18 years and above
3) Health facility workers - 18 years and above
4) District technical and political leaders - 18 years and above
5) Community Health Implementing partners - adults, 18 years and above |
USAID/ Uganda Health Systems Strengthening Activity (UHSS) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Pontiano Kaleebu
ID: UNCST-2020-R019901
|
Performance evaluation of the Determine™ HIV Early Detect 4th Generation HIV Rapid Diagnostic test
REFNo: HS2603ES
Primary Objectives:
1. To evaluate the Laboratory performance (Sensitivity and specificity) of the Determine™ HIV Early Detect
2. To assess the field performance of the Determine™ HIV Early Detect in parallel with the Determine™ HIV-1/2 test
Secondary Objective:
1. To assess the effectiveness of the Determine Early Detect to identify acute HIV infection among newly infected individuals
|
Buikwe, kawolo
Kampala, Kisenyi
Kampala, Naguru
Mityana, Mityana
Mukono, Mukono hospital
Wakiso, Wagagai
Wakiso, UVRI
Kayunga, Kayunga hospital
Kalungu, Nkozi hospital
Gomba, Gombe hospital
|
Uganda |
2022-12-23 18:06:59 |
2025-12-23 |
10,000 |
The study will enroll;
- Adults above 18 years of age
- Willing to have an HIV test.
- Eligible for testing as per the National HTS eligibility screening tool
- Documented
|
- Abott Diagnostics |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Lawrence Okello Rafaih
ID:
|
Evaluation practices and strategy performance of local NGOs in Uganda
REFNo: SS1561ES
4. To determine the relationship between organizational evaluation steering process and strategy performance of NGOs in Uganda,3. To establish the relationship between organizational evaluation technical expertise and strategy performance of NGOs in Uganda,2. To determine the relationship between evaluation planning process and strategy performance of NGOs in Uganda,1. To validate the contextual relevance of organizational effectiveness competency model for strategy evaluation of NGOs in Uganda.,The purpose of this study is to validate the extent to which evaluation practices influence strategy performance of national NGOs in Uganda.,
|
Moroto, Moroto
Gulu, Gulu
Kampala, Kampala
Mbarara, Mbarara
Moroto, Moroto
Gulu, Gulu
Kampala, Kampala
Mbarara, Mbarara
Lira, Lira
|
Uganda |
2022-12-19 12:19:45 |
2025-12-19 |
379 |
In short study targets adult population ( aged between 18-70 years)population from local NGOs who are members of the national NGO forums spread across the country. A total of 40 cluster NGO forums will be engaged to reach our to gather a proportionate sample of about 80 respondents per region. Similarly, Only adult respondents will be included for key informant interviews |
Lawrence Rafaih Okello |
Social Science and Humanities |
Clinical Trial |
Degree Award |
|
Daniella Ferguson
ID:
|
A Retrospective Analysis of Suramin Treatment forStage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (S1 TBR HAT) in Uganda and Malawi
REFNo: HS2582ES
Primary objectives
The primary objective is to determine whether standard of care treatment with suramin, as currently practiced in Uganda and Malawi, leads to better health outcomes in patients with S1 TBR HAT than observed in an untreated natural history cohort with source data from a published epidemiologic study.
Secondary objectives
The secondary objective is to evaluatethe safety and tolerability of suramin.
|
Kaberamaido, Lwala
|
South Africa |
2022-12-19 12:17:26 |
2025-12-19 |
150 -200 patients |
The study will include TBR HAT patients treated with suramin between 2000 and 2020 in Uganda and Malawi. The study will include all of the approximately 150 - 250 patients evaluated through chart review who are deemed eligible and have sufficient data. A natural history cohort composed of source data from approximately 200 patients from a published epidemiological study will be used as a comparator. |
PaxMedica, Inc. 303 South Broadway Suite 125 Tarrytown, NY |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
KENNETH MUGABE
ID: UNCST-2022-R010732
|
Using lactate testing to improve maternal sepsis identification: a multi-country test accuracy study: LACTate in mATernal sEpsis
REFNo: HS2589ES
VI. Conduct a validation study of an alternative reference standard in which the SOFA score is modified to incorporate maternity specific ranges for creatinine and platelet concentration.,V. Exploratory analysis will examine the effect of adjusting the threshold values for both vital sign and lactate assessment on the sensitivity and specificity of the index tests.,IV. To explore if the test accuracy of lactate in addition to maternal vital sign monitoring alone varies by the pre-specified subgroups of pregnancy status (pregnant or post-delivery (including abortion or miscarriage)) and recruitment country.,III. To explore if baseline venous lactate, in addition to vital sign measurements, improves prediction of severe morbidity and mortality from infection.,II. To assess short-term predictive value of lactate testing, by comparing the baseline index test with 24-hour reference standard, in those without sepsis at baseline.,I. Immediate diagnostic value of lactate testing by comparing the baseline index test with baseline reference standard.,Determine the diagnostic accuracy of maternal venous lactate measurement in addition to maternal vital sign thresholds, in maternal sepsis in low-resource health facility settings in Malawi, Uganda and Pakistan.,
|
|
Uganda |
2022-12-12 15:55:39 |
2025-12-12 |
500 (150 in Uganda) |
Women, 16years or greater, with suspected infections, who are pregnant or recently pregnant(up to 42 days) |
University of Liverpool |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
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 |
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|
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 |
|
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