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  
Ezekiel Mupere
ID: UNCST-2023-R008637
 Earlier prime-BOOST schedule to improve MEasles protection in high burden settings (BoostME)
REFNo: HS2883ES

Safety Objectives 1.To assess the safety and reactogenicity profile of the vaccine when given at different ages 2.To assess the number of measles infections throughout the study. Primary Objectives 1.To compare protective measles antibody concentrations at 2.5 years of age in infants receiving an early (6 months) compared to standard (9 month) dose of MCV, and a booster dose at 18 months of age. 2.To compare protective measles antibody concentrations one month after a second dose of MCV given at 12 months (early) compared to standard (18 months), in those who received an early (6 months) first dose. Secondary Objectives •To describe the measles antibody concentrations one month after first dose in infants receiving an early (6 months) compared to standard (9 month) dose of MCV. •To describe the effect of maternal antibodies on infant humoral and cellular immune response to first and second doses in children vaccinated under different schedules. •To describe the effect of maternal HIV infection on infant antibody responses post MCV1 and MCV2 given at different schedules •To describe the impact of different vaccination schedules on responses to the rubella component of the vaccine. Community Objectives To assess the effect of a measles vaccination clinical trial on public perceptions of measles immunisation
 Kampala, Kawaala
Kampala, Kisenyi
Kampala, Komamboga
Kampala, Mulago
 Uganda 2023-06-23 7:46:04 2026-06-23 450 infants Any infant aged 6 months (23-28 weeks) at screening visit and has not received prior vaccination against measles University of Oxford Research Governance, Ethics and Assurance Joint Research Office Boundary Brook House Churchill Drive Headington Oxford OX3 7GB United Kingdom, and funded by Bill and Melinda Gates Foundation. Medical and Health Sciences Clinical Trial Non-degree Award
Tonny Kiyimba
ID:
Efficacy of polyphenols from Tamarindus indica fruit juice on cardiometabolic health of patients living with HIV and elevated triglycerides: A study protocol
REFNo: HS2923ES

3. To establish dose response dynamics of long-term intake of T. indica fruit juice polyphenols on selected cardiometabolic risk markers of PLWH.,2. To assess the effect of an acute, single-dose intake of T. indica fruit juice on vascular function, lipid profile and plasma levels of procyanidin metabolites.,1. To produce and evaluate the sensory acceptability of T. indica fruit juice.,To determine the efficacy of T. indica fruit juice on selected cardiometabolic risk markers of PLWH in HIV community care model in Wakiso district, Uganda.,
 Wakiso, Kajjansi
Wakiso, Kajjansi
 Uganda 2023-06-20 11:05:36 2026-06-20 240 Participants will be adult(30-50 years) male and female patients living with HIV (PLWH) managed under the community-based model (Community Drug Distribution Points-CDDPs) in Wakiso district, central Uganda. The district encircles Kampala, Uganda's capital city with an estimated population of over 2.9 million people. The district has the highest prevalence (10%) of HIV in Uganda. Over 3,801 PLWH are currently receiving the HIV care from CDDPs in Wakiso District. The study inclusion and exclusion criteria are presented in Table 1. VLIROUS Medical and Health Sciences Clinical Trial Degree Award
Betty Mwesigwa
ID: UNCST-2020-R014667
 SABIN-002: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
REFNo: HS2838ES

To evaluate the safety and tolerability of
cAd3-Marburg vaccine
 Kampala, Nakasero
 Uganda 2023-06-14 11:06:46 2026-06-14 80 Male and female adults, 18-70 Years Sabin Vaccine Institute Medical and Health Sciences Clinical Trial Non-degree Award
NANKWASA SAILAS
ID:
RANDOMIZED CONTROLLED FOR NON USE OF ANTIBIOTIC AFTER UNCOMPLICATED VAGINAL BIRTH AND POST-PARTUM ENDOMETRITIS AT ST FRANCIS HOSPITAL NSAMBYA
REFNo: HS2768ES

3. To determine the factors that may predict the likelihood of infection after uncomplicated vaginal birth at St. Francis Nsambya Hospital,2. To determine the incidence of perineal tear/episiotomy wound breakdown among women who received antibiotic and those who do not at St. Francis Nsambya Hospital,1. To determine the incidence of post-partum endometritis after uncomplicated vaginal birth in women who receive antibiotic compared to those who do not at St. Francis Nsambya Hospital,To determine whether not providing an antibiotic after uncomplicated vaginal birth is associated with increased incidence of post-partum endometritis at St. Francis Nsambya Hospital,
 Kamuli, Nsambya
Uganda 2023-06-06 7:53:44 2026-06-06 260 participants adult post delivery mothers with uncomplicated vaginal birth NANKWASA SAILAS Medical and Health Sciences Clinical Trial Degree Award
RICHARD MPANGO STEPHEN
ID:
Adaptation and Evaluation of the New Forest Parenting Program (NFPP) in the management of ADHD among Children and Adolescents infected with HIV (CA-HIV) in Uganda (Formative phase)
REFNo: SS1721ES

i) To adapt and evaluate the effectiveness of the NFPP in the management of ADHD among Children and adolescents infected with HIV (CA-HIV).
ii) To evaluate the acceptability and feasibility of NFPP in the management of ADHD among CA-HIV.
 Masaka, NOT APPLICABLE
Kampala, NOT APPLICABLE
 Uganda 2023-05-29 20:36:58 2026-05-29 44 Twenty-two (22) participants; ten (10) Child and adolescent mental health specialists’ and HIV clinicians (representing a range of professional disciplines including psychiatrists, psychologists, psychiatric clinical officers, psychiatric nurses, experienced HIV counsellors and HIV clinicians); ten (10) parents / grandparents / teachers /day-mothers / guardians / caregivers; two (2) facilitators CHILD Global Research Social Science and Humanities Clinical Trial Degree Award
Richard Idro
ID: UNCST-2021-R013599
 Dihydroartemisinin-piperaquine and azithromycin for the post-discharge management of children with severe anaemia in Malawi, Kenya and Uganda; A, multicentre, parallel-group, two-arm, randomised, double-blind superiority trial.
REFNo: HS2815ES

To determine if PDMC with four courses of monthly AZ treatment in combination with four months of weekly DP is superior to PDMC with weekly DP-alone in reducing non-malaria SCCV by six months post-discharge in children aged <5 years admitted with severe anaemia (Hb<5g/dl) who are ready to be discharged and are clinically stable and able to switch to oral medication,
 Jinja, Jinja City
Kitgum, Municipality
 Uganda 2023-05-25 12:04:54 2026-05-25 958 Children aged less than 5 years, with severe anemia. Training and Research Unit of Excellence, Blantyre, Malawi Medical and Health Sciences Clinical Trial Non-degree Award
David Meya Bisagaya
ID: UNCST-2019-R000837
 Platform Trial For Cryptococcal Meningitis - PLATFORM-CM
REFNo: HS2649ES

The purpose of this study is to know whether this oral form of amphotericin (MAT2203) is safe and effective in the treatment of people sick with cryptococcal meningitis.
 Mbarara, Mbarara
Masaka, Masaka
Kampala, Kampala
 Uganda 2023-05-25 12:01:51 2026-05-25 270 Adult (18 years and above) males and females HIV-infected persons with cryptococcal meningitis. Matinas BioPharma Nanotechnologies, Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Dominik Biesalski
ID:
The Drivers, Effects and Measurement of Time Use Among the Urban Poor: Evidence from Uganda
REFNo: SS1674ES

Get insights into the time use patterns of urban workers and understand their effects on productivity and well-being.
 Kampala, Kampala
 Germany 2023-05-11 14:41:00 2026-05-11 200 Workers who are older than 18 years old, both men and women of all tribes Private Enterprise Development in Low-Income Countries (PEDL) Social Science and Humanities Clinical Trial Degree Award
James Davis KATUMBA
ID:
Uncontrolled asthma among adolescents in selected secondary schools in Kampala City: Prevalence, associated factors, in-school needs, pathways to care and effectiveness of an mHealth Self-management app
REFNo: HS2791ES

To determine the effectiveness, acceptability and feasibility of the KmAsthma self-management app in improving the control of asthma among day scholar secondary school adolescents 12-19 years old in Kampala City Uganda.,To examine pathways to asthma care and their influence on asthma control among secondary school adolescents with asthma in Kampala City Uganda ,To establish the in-school needs associated with asthma control among adolescents in selected secondary schools in Kampala City Uganda ,To determine the prevalence of and factors associated with uncontrolled asthma among adolescents in selected secondary schools in Kampala City Uganda ,To establish the prevalence of and factors associated with uncontrolled asthma, in-school needs, pathways to asthma care, and effectiveness of KmAsthma Self-management app intervention to control asthma among adolescents in selected secondary schools in Kampala City Uganda,
 Kampala, Kawempe, Rubaga, Makindye, Kampala Central, Nakawa
 Uganda 2023-05-02 22:22:49 2026-05-02 323 Secondary school adolescents in Kampala City Uganda who will provide written informed consent (or assent plus consent from parents in case of minors) during the time of the study. Self Sponsored Medical and Health Sciences Clinical Trial Degree Award
John Kellett Gale
ID:
Can continuous non-invasive monitoring of movement predict and detect clinical deterioration of hospital patients earlier and more efficiently than traditional intermittent observations?
REFNo: HS2765ES

To determine if continuously collected accelerometer data can indicate and identify clinical deterioration of acutely ill hospitalised patients before intermittently collected vital signs.
 Masaka, Ssenyange
 Ireland 2023-05-02 22:11:25 2026-05-02 1100 All non-pregnant patients aged 18 years or over admitted to the medical ward for any medical condition who are competent to provide consent to participate in the study or have a surrogate decision maker who can consent on their behalf. Patients may decide to participate or withdraw from the study at any time during their hospitalization. Dr John Kellett Medical and Health Sciences Clinical Trial Non-degree Award
Grace Ndeezi
ID: UNCST-2019-R001802
 Nutritional management of growth faltering in infants aged under six months. Study protocol for an individually randomised trial
REFNo: HS2766ES

To determine the effect of nutritional supplementation plus intensive breastfeeding support compared with intensive breastfeeding support alone on mortality, morbidity and growth in infants aged 0-6 months with growth faltering in low resource settings in South Asia and Sub-Saharan Africa.
Iganga,
Iganga,
Iganga,
Iganga,
Iganga,
Mayuge,
Mayuge,
Uganda 2023-04-26 11:15:23 2026-04-26 900 infants Pregnant women (and adolescents) aged 15 to 45 years. Their babies will be enrolled at birth for a nutritional intervention. Both female and male babies will be enrolled. There will be no exclusion based on tribe as long as they comprehend English and Lusoga. World Health Organisation Medical and Health Sciences Clinical Trial Non-degree Award
ELIZABETH ASIGE
ID:
THE IMPACT AND COST-EFFECTIVENESS OF A COMMUNITY-BASED PROGRAM FOR CHILDREN WITH CEREBRAL PALSY AND THEIR CAREGIVERS AND THE STAKEHOLDERS IN UGANDA.
REFNo: HS1979ES

1. To examine the impact of a community-based program on children with CP reported frequency of participation in the home, school, and community activities. 2. To assess the impact of a community-based training program on improving caregiver knowledge regarding CP and reducing caregiver stress. 3. To determine the impact of a communication and advocacy program in broadening stakeholders’ knowledge, attitude and practices regarding childhood disability and inclusion. 4. To determine the cost-effectiveness of a community-based program on children with CP, their caregivers, and the stakeholders in relation to costs and benefits.
Iganga, Iganga
Mayuge, Mayuge
 Uganda 2023-04-20 21:15:22 2026-04-20 100 participants- 50 in the study group and 50 in the control group The study population will comprise children and youth with cerebral palsy aged 2-22 years, both male and female, and their primary caregivers of any tribe living in the study communities plus the community stakeholders Prof. Hans Forssberg -Karolinska Institutet Astrid Lindgren Children’s Hospital 17176, Stockholm Sweden Medical and Health Sciences Clinical Trial Degree Award
Beatrice  Onyango Ekesa
ID:
Bio-efficacy of Pro-Vitamin A-rich banana to improve vitamin A status among children in Uganda living in an area with a high burden of inflammation
REFNo: HS2721ES

3. Establish the stability of retinol isotopes on DSS at room temperature in the determination of TBS of vitamin A.,2. Assess the effect of inflammation and nutritional status on vitamin A absorption and TBS assessment among school-aged Ugandan children.,1. Determine the bio-efficacy of carotenoids in Pro-Vitamin A rich bananas in improving TBS in children aged 6-14years.,This study will determine the bio-efficacy of carotenoids in Pro-Vitamin A-rich banana-based diets and their potential in improving the vitamin A body stores by the RID technique among school-going children aged 6-14years living in Tororo district, an area with a high burden of inflammation.,
 Tororo, Aturukuk
 Kenya 2023-04-19 12:44:24 2026-04-19 110 The study will be conducted among school going children aged 6-14 years because the school setting facilitates the feeding trial and monitoring, and the age group forms the youngest group available in an organised setting that can easily be engaged for a long period. In addition, this age group is not involved in the current national vitamin A supplementation programs. International Atomic Energy Agency (IAEA) Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Evaluation of National HIV Testing Services Algorithm
REFNo: HS2701ES

Main Objective
To determine the appropriate HIV rapid test algorithm to be used in Uganda considering the new kits on the market.

Specific objectives
1. To assess specificity, sensitivity, negative predictive value (NPV), positive predictive value (PPV) of the rapid HIV tests on the market in Uganda and come up with best RDT algorithm.
2. To identify an algorithm that will best identify acute HIV infections
3. To determine the inter-observer and inter-lab agreement in HIV diagnosis using evaluated RDTs.

 Gulu, Lacor hospital
Mbarara, Mbarara hospital
Tororo, AIC and TASO
Central Region, UVRI CLINIC
 Uganda 2023-04-12 15:44:58 2026-04-12 3500 Adults aged 18 years and above who would have come for an HIV test The Global Fund Medical and Health Sciences Clinical Trial Non-degree Award
Francis Ssali
ID: UNCST-2021-R012134
 Protocol A5394: “Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with both Chronic Hepatitis B and HIV” Version 1.0, May 27, 2022
REFNo: HS2647ES

1.2 Primary Objectives

1.2.1 To assess the safety and tolerability of treatment with SLGN administered once weekly by mouth for 24 weeks.

1.2.2 To determine the proportion of participants with ≥1 log10 IU/mL decline in quantitative HBsAg (qHBsAg) after SLGN treatment at Week 24.

1.3 Secondary Objectives

1.3.1 To determine the proportion of participants with ≥1 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.2 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg after SLGN treatment at Week 24.

1.3.3 To determine the proportion of participants with ≥0.5 log10 IU/mL decline in qHBsAg at any time during the study after SLGN treatment initiation.

1.3.4 To evaluate the proportion of participants who achieve HBsAg loss after SLGN initiation and who sustain HBsAg loss during follow-up.

1.3.5 To evaluate changes in qHBsAg levels at Weeks 4, 12, 24, 36, and 48 after SLGN initiation and, separately, among the placebo recipients.

1.3.6 To determine the proportion of HBeAg positive participants at baseline who lose HBeAg at any time during the study, by study arm.

1.3.7 To determine the proportion of anti-HBe negative participants at baseline who develop anti-HBe at any time during the study, by study arm.

1.3.8 To determine the proportion of hepatitis B surface antibody (anti-HBs) negative participants at baseline who develop anti-HBs at any time during the study, by study arm.
1.3.9 To evaluate levels of circulating cytokines, including IFN-gamma, IL-12p40, IL-1RA, and CD163 at entry, 24 hours post-first study drug dose, Weeks 4, 12, 24, 36, and 48, by study arm.

1.3.10 To determine whether administration of SLGN will perturb HIV latency as measured by an increase in HIV transcription.

1.3.11 To determine whether administration of SLGN will decrease the size of the latent reservoir, as measured by the change in amount of cell-associated unspliced HIV RNA, HIV DNA, replication-competent and/or intact virus at Weeks 2, 4, 24, and 48.

1.4 Exploratory Objectives

1.4.1 To define the pharmacokinetic (PK) profile and PK-pharmacodynamic (PD) associations of SLGN in people with both HIV and CHB taking suppressive antiviral therapy for both viruses.

1.4.2 To explore if SLGN and antiretroviral (ARV) PK are altered when administered together.

1.4.3 To evaluate participants’ adherence by using several tools, including self-report, directly observed therapy (DOT), and drug concentrations.

1.4.4 To compare quantitative changes in experimental measures of HBV antiviral efficacy (including HBV RNA, hepatitis B core related antigen [HBcrAg], qHBeAg, and low positive HBsAg measured with a high sensitivity qHBsAg assay [LLOQ of 0.05 IU/mL]) and measure changes in large, medium, and small HBsAg isoforms from baseline during and after treatment.

1.4.5 To determine the immunological effects of SLGN on circulating immune signaling by performing single cell RNA sequencing using peripheral blood mononuclear cells (PBMCs) and evaluating HIV-specific T-cell responses.

1.4.6 To determine the effects on circulating immune cells, including cellular phenotypes and T and B-cell responses.

1.4.7 To determine whether administration of SLGN will affect levels of circulating cytokines, including TNF-alpha, IL-12, IL18, IP-10, ISG15, IL-21, Fas Ligand, and TRAIL.

 Kampala, Seguku
 Uganda 2023-04-12 14:38:49 2026-04-12 The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if replacements are needed for key analyses. Participants with both (1) HIV and chronic hepatitis B (CHB) on suppressive effective antiviral therapy for HIV (ART) and HBV for ≥5 years immediately prior to study entry and (2) screening quantitative hepatitis B surface antigen (qHBsAg) >1000 IU/mL, and without evidence of advanced liver fibrosis or cirrhosis. Enrollment of women (female sex assigned at birth) is encouraged, and the study will set an enrollment goal of at least 14 women. The study is expected to enroll participants in North America, South America, Africa, and Asia. For the first 9 months, enrollment will be capped at 24 participants at US sites and 24 participants at non-US sites. After 9 months, enrollment will be open to all sites without regional caps The total sample size will be 48 participants (36 active and 12 placebo). Up to 6 additional participants may be enrolled if r eplacements are needed for key analyses. There are no Uganda specific differences. National Institute of Allergy and Infectious Diseases, Gilead Sciences, Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 A multiple arm, multiple stage (MAMS), phase 2B/C, open label, randomized, controlled platform trial to evaluate experimental arms including an increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin and sutezolid, in adult subjects with newly diagnosed, smear-positive pulmonary tuberculosis
REFNo: HS2644ES

Primary Efficacy Objective:
Rifampicin- containing experimental arms (arms 1,2)
To evaluate whether one or more of two experimental regimens based on
optimized dose rifampicin, optimized dose of pyrazinamide, and moxifloxacin
given for 12, respectively 17 weeks, are superior to standard treatment given for
26 weeks, as assessed by time to sputum culture conversion to negative in liquid
media.
Sutezolid-containing experimental arm (arm 4)
 To evaluate whether the efficacy of an experimental regimen composed of
sutezolid, delamanid, bedaquiline, and moxifloxacin given for 17 weeks is
superior to standard treatment given for 26 weeks, as assessed by time to
sputum culture conversion to negative in liquid media.
Secondary Objectives This study’s secondary objectives are:
Efficacy
 To assess treatment efficacy based on proportion of patients with relapse
free outcome at 12 months after randomization.
 To assess treatment efficacy based on the rate of decline of bacterial load
measured by the Molecular Bacterial Load Assay
 To rank the relative efficacy of the experimental four-drug combinations
for the treatment of pulmonary tuberculosis within the first twelve weeks
of treatment, and select the most efficient experimental treatment
regimen or regimens for further development.
Safety and Tolerability
To assess the frequency, severity, and type of adverse events (AEs), and AErelated
treatment discontinuations.
Pharmacokinetics
To describe the pharmacokinetics of the drugs and doses used, and to assess
possible relationships between pharmacokinetic parameters of the various drugs and between pharmacokinetic parameters and participant characteristics.
Pharmacodynamics To describe relationships between pharmacokinetic parameters on the one hand and efficacy and safety endpoints on the other hand.
 Kampala, Kawempe
 Uganda 2023-04-11 15:27:11 2026-04-11 360 Adults A total of up to 360 adult (≥ 18 years of age) participants will be enrolled. In case of a high number of dropouts or non‐evaluable participants, it may be necessary to recruit more participants into the study. Also, if the stage 2 starts later than stage 1, it will be necessary to increase the number of control arm participants to achieve a 1:1 ratio of concomitantly recruited control and arm 4 participants (see sample size considerations). Both males and females regardless of tribe as long as an ICF of that particular language spoken by the participant is available, will be enrolled. LMU Klinikum Marchioninistr. 15, 81377 Munich Germany Medical and Health Sciences Clinical Trial Non-degree Award
Brenda Kakayi Catherine
ID: UNCST-2022-R008787
 Insulin-like Growth Factor/Growth Hormone Levels and Stunting in HIV Exposed Uninfected Children from the 1077BF/P1084s study (CHASE: Changes in IGF/Hormone Axis and Stunting in HIV-Exposed uninfected children.
REFNo: HS2686ES

1. To investigate IGF-1, IGFBP-1, and IGFBP-3 as predictors of growth faltering/stunting in the first 2 years of life in HEU children

2. To describe the concentrations of hormonal growth factors in infants in relation to infant growth percentile at birth, 26 weeks, and 74 weeks of age.

Uganda 2023-04-03 20:41:44 2026-04-03 Samples from approximately 154 participants from the P1084s study Samples of approximately 154 P1084s HEU children with serum specimens available at birth, week 26, and week 74 will have assays done on stored specimens for IGF-1, IGFBP-1, and IGFBP-3 at these time points. The 154 participants will be randomly selected from the 268 participants from Uganda, Malawi and South Africa that were enrolled in the study. The samples for use will be from both male and female participants. DAIDS-IMPAACT Network Medical and Health Sciences Clinical Trial Non-degree Award
JOSELYN RWEBEMBERA
ID: UNCST-2021-R013915
 Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease: A non-inferiority randomized trial. (GOALIE)
REFNo: HS2659ES

Primary Objective:
To compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.

 Lira, Adyel
 Uganda 2023-03-24 2:23:26 2026-03-24 1004 Age group = 5-17 Sex not specified. Tribe not specified. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
 Long-Acting Treatment in Adolescents (LATA); A randomized open-label 2-arm 96-week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa version 1.0 dated 01 December 2021.
REFNo: HS2515ES

• To evaluate an innovative and contemporary ART strategy in HIV- positive adolescents to provide choice for young people facing life-long treatment.
• To evaluate the virological efficacy, safety, acceptability, and quality-of-life of the dual long-acting injectable combination, cabotegravir and rilpivirine, antiretroviral therapy compared to continuous daily oral therapy with triple oral ART consisting of DTG with a backbone of tenofovir either as the TAF or TDF formulations, combined with either 3TC or FTC regimen, to optimize treatment for HIV-positive adolescents in sub-Saharan Africa.

 Kampala, Mulago
 Uganda 2023-03-16 13:14:16 2026-03-16 170 Adolescents aged 12 to 19 years of age living with HIV-1 who are not pregnant or breastfeeding, and are virologically-suppressed (HIV-1 RNA <50 copies/mL) for at least one year, without any known history of treatment failure, on a 3-drug combination ART consisting of an anchor drug with a 2-drug nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone. There will be no exceptions to eligibility requirements at the time of randomisation. Questions about eligibility criteria should be addressed prior to attempting to randomise the participant. The eligibility criteria are the standards used to ensure that only medically appropriate patients are considered for this study. Patients not meeting the criteria should not join the study. For the safety of the patients, as well as to ensure that the results of this study can be useful for making treatment decisions regarding other patients with similar diseases, it is important that no exceptions be made to these criteria for admission to the trial. Participants will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria as defined below. INCLUSION CRITERIA 1. HIV-1-positive 2. Aged 12-19 years 3. Aware of HIV status 4. Body weight ≥35Kg 5. On ART consisting of 2NRTI and a third agent 6. On ART for ≥1 year with no previous regimen change for treatment failure* 7. Virologically suppressed with all HIV-1 RNA viral loads <50copies/mL¥ in the last 12 months up to and including screening. Additionally, there must be one result <50copies/mL¥ at least 12 months prior to screening and the viral load at trial screening must be <50 copies/mL 8. Written informed consent provided by participant (if aged 18 to 19 years) and/or carer/legal guardian (if participant aged 12 to 17 years) as appropriate 9. Written informed assent in participants aged 12 to 17 years 10. Females who are sexually active must be willing to adhere to highly effective methods of contraception⌂ EXCLUSION CRITERIA 1. Known HIV-2 positive 2. Females who are pregnant or breastfeeding 3. Females who plan to become pregnant during the trial follow-up or are sexually active and are unwilling to avoid pregnancy for the duration of the trial 4. Moderate or high-risk score on the Columbia-Suicide Severity Rating Scale 5. Hepatitis B SAg positive 6. ALT ≥3 x upper limit of normal 7. On treatment for active TB 8. Known contraindication to receipt of dolutegravir, cabotegravir, rilpivirine, emtricitabine/ lamivudine and any formulation of tenofovir 9. Participants determined by the investigator to have a high risk of seizure, including those with unstable or poorly controlled seizure disorder 10. Unwilling or contraindication to receiving injections 11. Contraindication to receiving injectable agents in the buttock area 12. Underlying medical condition (e.g. bleeding disorder; use of warfarin) that in the opinion of the investigator precludes participation 13. Previous randomisation in the BREATHER Plus trial University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership Medical and Health Sciences Clinical Trial Non-degree Award
Victoria Ndyanabangi
ID: UNCST-2021-R012645
 IMPAACT 2036: Phase I/II Study of the Safety, Tolerability,Acceptability, and Pharmacokinetics of Oral and Long-ActingInjectable Cabotegravir and Rilpivirine in Virologically SuppressedChildren Living with HIV-1, Two to Less Than 12 Years of Age, DAIDSStudy ID #38932 IND # 138754
REFNo: HS2688ES

To propose the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV)followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA)in children living with HIV-1, and to describe participant choice and experience with theregimen with or without an oral lead-in period.
To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable)through Week 24
To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oraland injectable) through Week 24
To assess the safety of CAB + RPV (oral and injectable) through Weeks 48 and 72
To describe the repeat-dose pharmacokinetics of injectable CAB LA + RPV LA throughWeeks 48 and 72
To assess the maintenance of viral suppression of CAB + RPV (oral and injectable)through Weeks 24, 48, and 72
To evaluate the tolerability and acceptability of injectable CAB LA + RPV LA throughWeeks 24, 48, and 72
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during study treatment
To assess immunologic activity of CAB + RPV (oral and injectable) through Weeks 24,48, and 72
To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable)and 44 weeks of CAB LA + RPV LA (injectable only)
To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV(oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe the maintenance of viral suppression and immunologic activity of 48 weeks ofCAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CABLA + RPV LA (injectable only)
To characterize long-term safety and washout PK through 48 weeks after permanentdiscontinuation of injectable CAB LA + RPV LAV LA
To characterize PK of CAB + RPV oral formulations when dispersed in liquid vs. directly ingested (Weight Bands 3, 4 and 5)
 Kampala, Mulago
 Uganda 2023-03-16 12:55:20 2026-03-16 35 Children living with HIV-1, two years to less than 12 years of age and weighing ≥10 kg and <40 kg, who are Virologically suppressed on stable antiretroviral therapy and their parents/caregivers. Proposed the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV) followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA) in children living with HIV-1, and to describe participant choice and experience with the regimen with or without an oral lead-in period. National Institute of Allergy and Infectious Diseases (NIAID) Medical and Health Sciences Clinical Trial Non-degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
 GS-US-380-1474: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
REFNo: HS2708ES

This is a multisite, multi-cohort study that aims to recruit subjects in four weight-based cohorts (i.e. Cohort 1, 2, 3 and 4), with each cohort having specific objectives aligned with it. Baylor Uganda site will recruit subjects in cohort 4 with is further subdivided in 4 weight-based sub-groups. The study objectives in relation to the Cohort 4 are as follows;
Cohort 4
Group 1:
The primary objective of this study is:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 24 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets

• To evaluate the antiviral activity of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Weeks 24 and 48 in HIV-1 infected, virologically suppressed children ≥ 2 years of age weighing ≥ 14 to < 25 kg who are unable to swallow tablets
Group 2:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg

• To evaluate the antiviral activity of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 10 to < 14 kg.
Group 3:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg

• To evaluate the antiviral activity of B/F/TAF 3.75/15/1.88 mg (administration of 1 × B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 6 to < 10 kg.
Group 4:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg.

• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

• To evaluate the antiviral activity of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ≥ 1 month of age, on ARV treatment or treatment naive, weighing ≥ 3 to < 6 kg

 Kampala, Mulago
 Uganda 2023-03-16 12:47:17 2026-03-16 10 4.1 Selection of the Study Population Approximately 170 pediatric subjects ≥ 1 month to < 18 years of age are planned to be enrolled into the entire study. However, 50 child subjects shall be recruited as follows for Cohort 4 across all participating sites; at least 8 evaluable subjects ≥ 2 years of age weighing ≥ 14 to < 25 kg and at least 42 evaluable subjects ≥ 1 month of age weighing ≥ 3 to < 14 kg are planned to be enrolled. Baylor Uganda site however, plans to recruit a total of 10 children in cohort 4 (i.e. 3 children in each of the groups 1, 2 and 3 and 1 child in group 1). In addition, replacement subjects may be enrolled for subjects whose Intensive PK data are not evaluable or who do not complete all Intensive PK procedures in Groups 2, 3, and 4 of Cohort 4. 4.2 Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. a) Age ≥ 1 month to < 18 years (according to requirements of enrolling Cohort) b) Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements. c) Body weight at screening for Cohort 4: • Group 1: ≥ 14 to < 25 kg (≥ 31 to < 55 lbs) • Group 2: ≥ 10 to < 14 kg (≥ 22 to < 31 lbs) • Group 3: ≥ 6 to < 10 kg (≥ 13 to < 22 lbs) • Group 4: ≥ 3 to < 6 kg (≥ 6.6 to < 13 lbs) d) Confirmed HIV infection if < 18 months of age (positive nucleic acid-based test result to be provided). e) Adequate renal function: • Estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73 m2 (≥ 1.5 mL/sec/1.73 m2) for children ≥ 1 year of age using the Schwartz Formula. • Adequate renal function: eGFR ≥ the minimum normal values for age for children < 1 year of age using the Schwartz Formula. o Schwartz formula (mL/min/1.73 m2) = k × L/SCr where k is a proportionality constant, L is height in centimetres (cm) and SCr is serum creatinine (mg/dL). The value of k is 0.45 for children < 1 year old, 0.55 for children ≥ 1 to < 12 years old and adolescent girls ≥ 12 years old and 0.70 for adolescent boys (≥ 12 years old). f) Stable ARV regimen: • Stable ARV regimen of 2 NRTIs in combination with a third agent for a minimum of 6 months prior to the screening visit. Subjects undergoing dose modifications to their ARV regimen for growth or who are switching medication formulation(s) are considered to be on a stable ARV regimen (Cohort 4 Group 1). • Stable ARV treatment of 2 NRTIs in combination with a third agent for a minimum of 1 month prior to the screening visit or treatment naive (Cohort 4 Groups 2, 3, and 4 only) (patient is considered treatment naive if ARVs were given for prevention of mother-to-child transmission only and not for HIV treatment) g) Plasma HIV-1 RNA: < 50 copies/mL at the screening visit (Cohort 4 Group 1). No threshold for HIV RNA levels for Cohort 4 Groups 2, 3, and 4. h) Life expectancy ≥ 1 year. i) Have no documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R. Subjects with M184V/I AND HIV-1 RNA < 50 copies/mL may be enrolled in Cohort 4. Subjects in Cohort 4 with HIV-1 RNA > 50 copies/mL shall have documentation of no FTC, TFV, or INSTI resistance by plasma testing at screening (> 200 copies/mL) or historical genotype (if > 50 copies/mL but < 200 copies/mL). j) Care taker(s) must be willing and able to comply with all study requirements. 4.3 Exclusion Criteria Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. a) Cohort 4 Group 1: CD4 cell count < 200 cells/ mm3. Cohort 4 Groups 2, 3, and 4: CD4 cell count < 750 cells/mm3 for ≥1 to <12 months of age and < 500 cells/mm3 for ≥12 to <24 months of age. b) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening. c) An ongoing serious infection requiring systemic antibiotic therapy at the time of screening d) Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months e) Acute hepatitis in the 30 days prior to study entry f) Hepatitis B virus (HBV) surface antigen (HBsAg) positive g) Hepatitis C virus (HCV) antibody positive with detectable HCV RNA. Children < 18 months of age born to an HCV positive mother and/or HCV antibody positive will need to have 2 negative HCV RNA tests 6 months apart with the first test occurring no earlier than 2 months of age. In this situation, the earliest such a patient can be screened for study eligibility is at 8 months of age. h) Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, haematological, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to Day 1. i) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy) j) A history of or ongoing malignancy other than cutaneous Kaposi’s sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study. k) ≤ 2 months of age and gestational age (GA) ≤ 37 weeks (Cohort 4 Groups 2, 3, and 4) l) Current alcohol or substance abuse (by parent/caretaker) judged by the Investigator to potentially interfere with subject compliance m) Have history of significant drug sensitivity or drug allergy n) Known hypersensitivity to the IMP, the metabolites, or formulation excipients. o) Participation in any other clinical trial, including observational studies without prior approval from sponsor is prohibited while participating in this trial. p) Cohort 4 Groups 2, 3, and 4: Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrolment q) Subjects receiving ongoing therapy with any medication that is not to be taken with the study drug. Administration of any of the following medications must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study, with the exception of the subject’s prior ARV treatment regimen, which must be continued until their scheduled Day 1 visit Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 Medical and Health Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
 Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 plus Pyronaridine Administered once Daily for 1 or 2 Days to Adults and Adolescents with Acute Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2736ES

To evaluate the safety and
tolerability of the M5717-
pyronaridine combination in
adult participants with acute
uncomplicated malaria due to
P. falciparum.
Secondary.
o describe the clinical efficacy
of the M5717-pyronaridine
combination in adult participants
with acute uncomplicated
malaria due to P. falciparum
 Tororo, Central
 Uganda 2023-03-16 12:35:56 2026-03-16 200 Participants Are ≥ 12 and ≤ 55 years of age (≥ 18 and ≤ 55 years of age for Part A) at the time of signing the informed consent. Type of Participant and Disease Characteristics: 2. Microscopic confirmation of acute uncomplicated P. falciparum using Giemsa-stained thick and thin film. 3. P. falciparum parasitemia of ≥ 1,000 to ≤ 50,000 asexual parasites/µL of blood in Part A and P. falciparum parasitemia of > 1,000 to ≤ 150,000 asexual parasites/µL of blood in Part B. 4. Axillary temperature ≥ 37.5ºC or tympanic temperature ≥ 38.0ºC (use as per COVID-19 protocols at the site [only at Screening]), or history of fever during the previous 24 hours (at least documented verbally). Weight: 5. Have a body weight ≥ 24 kg Merck Healthcare KGaA, Darmstadt, Germany an affiliate of Merck KGaA, Darmstadt, Germany Frankfurter Str. 250 64293, Darmstadt, Germany Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
 A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants.
REFNo: HS2646ES

The primary objective of this study is to confirm the dose of ATV/co or DRV/co in HIV-1 infected pediatric participants, to confirm the dose of F/TAF in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
 Mityana, Mityana
Mubende, Mubende
Masaka, Masaka
Rakai, Kalisizo
Kampala, Kampala
Wakiso, Entebbe
 Uganda 2023-03-09 23:33:04 2026-03-09 15 The study will be conducted in young children and adolescents aged 3 to < 18 years; HIV-1 infected on a stable antiretroviral regimen for a minimum of 3 months. In Uganda, the study will be conducted by researchers from the coordinating site, MU-JHU Research Collaboration, MU-JHU CARE – Kampala, Uganda, in collaboration with Africa Medical and Behavioral Sciences Organization (AMBSO) – Kampala and SICRA-TASO MULAGO National Referral Hospital, Masaka, Uganda. Gilead Sciences Inc Medical and Health Sciences Clinical Trial Non-degree Award
Raymond Tweheyo
ID: UNCST-2020-R014507
 Understanding the effect of varied financial compensation structure for improving the performance, motivation and retention of Community Health Workers in Uganda - a quasi experiment
REFNo: HS2689ES

General objective: To understand the effect of varied financial compensation structure for improving the performance, motivation and retention of Community Health Workers in Uganda.

Specific objectives:
1. To determine the optimal performance based financial incentive incentive's structure required for improving the performance, motivation and retention of CHWs.

2. To explore the acceptability and perceptions of potential sustainability of CHWs financial compensation structure to various stakeholders, including the CHWs, and the CHW supervisors at the district and Ministry of Health.

3. To explore the perceived value and impact of financial incentives on CHW's job satisfaction, personal income and livelihood.
 Wakiso, all parishes
Mpigi, all parishes
Mbale, all parishes
Jinja, all parishes
 UK 2023-03-07 10:40:31 2026-03-07 3,215 children under five, 720 Community Health Workers, 32 Key Informants 1. Women of reproductive age (18 to 49 years) who have a child under five years of age. 2. Community Health Workers (18 years and above) 3. Adult Key Informants - district, Ministry of Health and Implementing Partner officials USAID/ Living Goods Medical and Health Sciences Clinical Trial Non-degree Award
Rachel Brathwaite
ID:
Assessing the Feasibility of Economic Approaches to Prevention of Substance Abuse among Adolescents
REFNo: HS2683ES

Aim 1. Examine the prevalence and consequences of ADU in a cohort of 200 AYLHIV (ages 18-24) seen at six (6) HIV clinics in southwestern Uganda.
Aim 2. Using a mixed methods approach, identify the multi-level (individual, interpersonal, community and structural) factors associated with ADU among AYLHIV.
Aim 3. Using a subset of the sample, explore the feasibility and short-term effects of a family-based economic empowerment intervention on ADU among AYLHIV.

 Masaka,
Trinidad and Tobago 2023-03-02 15:32:31 2026-03-02 230 220 Adolescents and youths living with HIV aged 18-24 years. 10 healthcare providers aged >18 years. National Institute on Alcohol Abuse and Alcoholism Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
 PHASE 2C CLINICAL TRIAL OF NOVEL, SHORT-COURSE REGIMENS FOR THE TREATMENT OF PULMONARY TUBERCULOSIS: CRUSH-TB (Combination Regimens for Shortening TB Treatment)
REFNo: HS2650ES

Primary objective
(1) To compare the efficacy of each experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in liquid media.

Secondary objectives
(1) To compare the proportion of participants with a grade 3 or higher adverse event in each experimental arm with the control arm
(2) To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up to 52 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
(3) To compare the efficacy of each experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in solid media
(4) To compare the proportion of participants in each arm who convert liquid and solid sputum cultures to negative by (a) 8 weeks of treatment and (b) 12 weeks of treatment
(5) To describe the rate of all-cause study drug discontinuation in each arm
(6) To compare time to sputum culture positivity curves through 17 weeks in the Mycobacterial Growth Indicator Tube (Bactec MGIT960) across arms
(7) To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up up to 78 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
(8) To describe the population PK of bedaquiline and its M2 metabolite, with or without rifabutin co-administration (PK#1)
(9) To conduct pharmacokinetic/pharmacodynamics study of the test drugs to determine relationships between pharmacokinetic parameters (AUC, Cmax) and outcome measures (time to culture negativity or rate of change in TTP) using non-linear mixed effects models, adjusting for key covariates that may affect outcomes (e.g. companion drugs, HIV status, cavitary disease) (PK#2)

 Kampala, Mulago
 Uganda 2023-02-21 13:13:53 2026-02-21 288 overall, 100 in Uganda This will be a multisite international study. Male and female participants who are age 12 or older and have suspected or proven pulmonary tuberculosis will be enrolled into the study. Enrollment will be open to all TBTC sites willing to participate and who have completed trial start-up requirements. Target enrollment is at least 288 participants (96 participants per arm). Pregnant or breast-feeding individuals will be excluded from the study because of uncertainties about the safety of bedaquiline, delamanid, and moxifloxacin in these groups. The sex, ethnicity, and socioeconomic background of study participants are expected to mirror those of the populations served by local tuberculosis clinics and the populations most affected by tuberculosis worldwide. Co-enrollment in other therapeutic clinical trials is not allowed. U.S. Centers for Disease Control and Prevention Medical and Health Sciences Clinical Trial Non-degree Award
Wietse Tol
ID: UNCST-2021-R013085
 AlCohol use in HumanitariAN settings: a programme of work to address alcohol use disorders and associated adversities among conflict-affected populations in UGanda and UkrainE (CHANGE)
REFNo: SS1596ES

• To identify strategies and techniques from evidence-based alcohol use therapies which can be integrated into PM+, and to develop a new intervention called PM+A (Problem Management Plus Alcohol)
• To adapt PM+A to local circumstances, and to examine the feasibility, acceptability, perceived effectiveness, and preliminary impact of PM+A
• To evaluate effectiveness and cost-effectiveness of PM+A through two single-blind randomised controlled trials in Uganda and Ukraine
• To explore the process of implementation, and to identify, characterise and explain mechanisms that promote or inhibit the delivery and take-up of PM+A in both settings
• To examine the potential for scaling-up PM+A in Uganda and Ukraine

 Arua, Ofua zone Rhino Camp
 Netherlands 2023-02-17 12:18:30 2026-02-17 60 Adult South Sudanese men (>18 years) who meet all the following criteria.; Alcohol Use Disorder Identification Test (AUDIT) score 8-19 (Saunders et al., 1993) 2) Elevated levels of psychological distress (Kessler Psychological Distress Scale (ten item version) (K10 >6) (Kessler et al., 2002) Wellcome Trust and the Department of Health and Social Care, through the National Institute for Health Research Social Science and Humanities Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
 IMPAACT 2036: Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age. Version 1.0, 22 September 2022. DAIDS study protocol ID: 38932
REFNo: HS2599ES

iii. Cohort 2: To describe the maintenance of viral suppression and immunologic activity of 48 weeks of CAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only),iv. Cohort 2: To describe HIV-1 genotypes and phenotypes for children who experience virologic failure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CAB LA + RPV LA (injectable only),ii. Cohort Cohort 2: To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only),i. Cohort 2: To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable) and 44 weeks of CAB LA + RPV LA (injectable only),ii Cohort 1: To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oral and injectable) through Week 24,i.Cohort 1: To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable) through Week 24,
 Kampala, all parishes
Wakiso, all parishes
 Uganda 2023-02-13 11:10:13 2026-02-13 90 children and 90 parents/ caregivers worldwide but MUJHU plans to enroll 5 -15 children and 5-15 parents/ caregivers. Children living with HIV-1, two years to less than 12 years of age and weighing ≥10 kg and <40 kg, who are virologically suppressed on stable antiretroviral therapy and their parents/caregivers. DAIDS/NIH Medical and Health Sciences Clinical Trial Non-degree Award
Winnie  Muyindike R
ID: UNCST-2021-R013558
 A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on TLD in Sub-Saharan Africa.(RESOLVE)
REFNo: HS2620ES

Aim 2: Use simulation modeling to examine the clinical impact, costs, and cost-effectiveness of strategies to improve viral suppression after virologic failure on TLD. We will populate the previously validated Cost-Effectiveness of Preventing AIDS Complications-International (CEPAC-I) model with the novel clinical trial data from Aim 1 to project long-term clinical outcomes and cumulative lifetime costs. We will then compare the cost-effectiveness of the three strategies evaluated in Aim 1 for addressing virologic failure among people treated with first-line TLD in Uganda or South Africa. ,Aim 1: Conduct a randomized clinical trial to determine the optimal strategy for management of virologic failure on first-line TLD in SSA. We will recruit 648 adolescents and adults with two viral loads >1,000 copies/mL while on first-line TLD for at least 12 months, who are in care at one of six public-sector HIV clinics in Uganda or South Africa. We will randomize participants to one of the following strategies, stratified by clinic and prior NNRTI-exposure: a) Maintenance on TLD with switch to protease inhibitor (PI)-based second-line ART if virologic failure persists past six months; b) Individualized Care, with regimen choice based on results of genotypic resistance tests and urine tenofovir assays; or c) Immediate Switch to PI-based second-line ART. The primary outcome will be viral suppression (<50 copies/mL) at 48 weeks post-enrollment using the FDA snapshot definition. We hypothesize that rates of viral suppression at 48 weeks will be higher in the Individualized Care arm than in the Maintenance on TLD and Immediate Switch arms.,
 Mbarara, Kamukuzi
Mbarara, Kakoba
 Uganda 2023-02-09 11:06:56 2026-02-09 324 15 years and above, female and male wo are on TLD irrespective of tribe National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
 A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19
REFNo: HS2642ES

The main intent of the study is to evaluate the efficacy of S-217622 vs. placebo. The study will be conducted in the setting of the locally available standard-of-care COVID-19 treatment. High-risk and low-risk participants will be analyzed together for the primary analysis and separately for secondary analyses. The following primary, secondary, and exploratory objectives will be addressed in the modified intent-to-treat (mITT) population, except for the safety analyses, which will be analyzed in the Safety population, and pharmacokinetic (PK) analyses, which will be analyzed in the PK population.
 Tororo, All Parishes
 Uganda 2023-02-06 17:17:04 2026-02-06 Each site in Uganda will (through competitive enrolment) enroll at least 8 participants making a total of 32 participants for all Uganda sites. Outpatient adults (≥18 years) with: a) documented positive SARS-CoV-2 nucleic acid or antigen test from a sample collected ≤120 hours (5 days) prior to randomization, b) onset of symptoms of COVID-19 ≤5 days prior to randomization, c) presence of 1 or more select COVID-19 symptoms within 24 hours prior to randomization. Participants will be eligible regardless of vaccination status and will be classified as either high risk or low risk. High-risk participants: defined as aged ≥65 years or those with presence of high-risk conditions. National Institute of Allergy and Infectious Diseases (NIH), Division of AIDS (DAIDS) 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
Kathy Burgoine
ID: UNCST-2022-R011521
 Impact of prophylactic Continuous Positive Airway Pressure in the Delivery Room (DR-CPAP) on neonates <1500g in a low-resource setting: A feasibility trial
REFNo: HS2605ES

- To determine the acceptability of DR-CPAP to healthcare workers in a low-resource setting - To determine the post-intervention acceptability of using a two-stage consent process in neonatal emergencies in the delivery room in this setting - To evaluate the feasibility of a third-party allocation process for randomisation by determining the time to randomization - To evaluate feasibility of initiating DR-CPAP in a low-resource setting in infants with birthweight 800-1500g within 15 minutes of delivery - To determine the safety of initiating DR-CPAP in a low-resource setting - To estimate the sample size to be used for future evaluation in the full trial - To assess the feasibility of secondary outcome measures to be used in the full trial
Mbale,
UK 2023-02-02 12:18:23 2026-02-02 100 The study population will be inborn preterm infants with a birthweight of 800g to less than 1500g who are spontaneously breathing at 5 minutes of life. They will be recruited within 15 minutes of birth and followed up until death or 28 days. Both male and female infants will be included. Mbale Clinical Research Institute (MCRI) Medical and Health Sciences Clinical Trial Non-degree Award
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
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
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