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 |
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|
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 |
|
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 |
|
Nixon Niyonzima
ID: UNCST-2020-R014577
|
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 (Lidera)
REFNo: HS2193ES
Main Objective
1. To demonstrate superiority of giredestrant over the control treatment.
Specific Objectives
1. To evaluate the efficacy of giredestrant compared with Therapy of Physician's Choice
2. To evaluate the safety of giredestrant compared with Therapy of Physician's Choice
3. To characterize giredestrant Pharmacokinetics
4. To evaluate health status utility scores of participants treated with giredestrant compared with Therapy of Physician's Choice
5. To evaluate the tolerability of giredestrant compared with Therapy of Physician's Choice
6. To identify and/or evaluate biomarkers that are predictive of response to giredestrant (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 giredestrant, 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 giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety
|
Kampala, Mulago
|
Uganda |
2023-07-13 10:07:44 |
2026-07-13 |
18 |
women aged 18 years of age and over with histologically confirmed breast cancer |
Hoffman La Roche |
Medical and Health Sciences |
Clinical Trial |
Non-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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Noella Okalany Akwi Regina
ID: UNCST-2022-R011085
|
Congenital Cytomegalovirus Infection in Eastern Uganda
REFNo: HS2668ES
To determine the short-term neurodevelopmental outcomes and hearing impairment associated with congenital cytomegalovirus among infants in Eastern Uganda.,To determine the incidence of, and risk factors for postnatally acquired cytomegalovirus among infants in Eastern Uganda.,To describe the factors associated with congenital cytomegalovirus infection in neonates in Eastern Uganda.,To determine the prevalence of congenital cytomegalovirus infection among neonates in Eastern Uganda,To investigate the burden of congenital cytomegalovirus and its outcomes among infants in Eastern Uganda.,
|
Mbale, Mbale
Budaka, Budaka
|
Uganda |
2023-02-06 16:21:08 |
2026-02-06 |
2000 |
0 - 6 months of age |
University of Liverpool |
Medical and Health Sciences |
Clinical Trial |
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 |
|
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 |
|
Proscovia Nabunya
ID: UNCST-2019-R000970
|
Testing the Feasibility and Acceptability of a Combination Intervention to Address Mental Health among Refugee Youth in Uganda
REFNo: SS2834ES
This proposed two-year study will be conducted in two phases. The first phase seeks to understand whether the COVID-19 pandemic had differential impact on refugee youth living in different settings. The second phase will test the feasibility and acceptability of an innovative combination intervention that has not been previously tested among refugee youth to address psychological problems that have increased since the onset of the COVID-19 pandemic.
Aim 1. To examine the mental health impact of COVID-19 on refugee youth living in Bidibidi refugee settlement compared to refugee youth living in urban centers (Arua town) in northern Uganda.
Aim 2. To test the feasibility, acceptability and preliminary short-term impact of an innovative intervention combining the youth readiness intervention (YRI) with youth development accounts and financial literacy training (YDA-FLT) to address the mental health impact of COVID-19 among refugee youth living in Bidibidi refugee settlement in northern Uganda.
|
|
Uganda |
2024-08-19 11:03:04 |
2027-08-19 |
200 |
The total sample size needed for the Refugee Youth COVID-19 study is 200 refugee youth, 15 to 24 years of age. Specifically, we will recruit 100 refugee youth from the five zones within Bidibidi Refugee settlement and another 100 youth among refugee youth living in Arua town (urban center). Youth will be recruited from centrally located ration distribution centers in the settlement, through churches, and youth advocacy groups led by refugee youth in Arua town that we will partner with. For the pilot RCT component, we will only include the 100 participants in Bidibidi refugee settlement with 50 randomized to the treatment group and the other 50 randomized to usual care group. |
Washington University in St. Louis |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
|
Edrisa Mutebi Ibrahim
ID:
|
Safety of JNK61 in Healthy Human Volunteers.
REFNo: HS2474ES
To determine the effect of JNK61 on the blood sugar levels in healthy human volunteers.,To determine the safety of JNK61 in healthy human volunteers,
|
Kampala, Makerere University
|
Uganda |
2023-08-30 16:05:54 |
2026-08-30 |
50 |
Male and female adults of any tribe |
Government of Uganda through Makerere University Research and Innovations Fund |
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).
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Nakaseke, Semuto
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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 |
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Kamya Moses
ID: UNCST-2020-R014203
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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.
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Bushenyi, All parishes
Mbarara, All parishes
Ntungamo, All parishes
Sheema, All parishes
Mbarara, All parishes
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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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Fred Ssewamala
ID: UNCST-2020-R014060
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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.
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Masaka, Kimaanya
Rakai, Kakuuto
Kyotera, Kyotera TC
Lwengo, Lwengo
Kalungu, Bukulula
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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 |
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Proscovia Nabunya
ID: UNCST-2019-R000970
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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.
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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.
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National Institute of Mental Health (NIMH) |
Social Science and Humanities |
Clinical Trial |
Non-degree Award |
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