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  
Angelina Kakooza-Mwesige
ID: UNCST-2020-R014529
EVALUATION OF THE IMPACT OF THE THREE TIER INTERVENTIONS FOR DISABILITY IN EARLY CHILDHOOD (IDEC) PROGRAMME IN UGANDA
REFNo: HS5596ES

GENERAL OBJECTIVE

The overall aim of this study is to evaluate the impact of the three-tier IDEC model piloted in the two districts of Mubende and Kassanda in Uganda, with a twofold purpose: (1) to improve intervention design and management and (2) to inform decisions about future investment and scale-up by establishing evidence and impact.

SPECIFIC OBJECTIVES.

Primary objectives
1. To determine the coverage of vision screening at 0-3 months and developmental screening at 9 and 18 months in the study sites.
2. To determine the change in functional abilities in children receiving the Tier 2 intervention.
3. To evaluate effects of the individualised (Tier 3) program at regular intervals (at least every 3 months) on child and family functioning, well-being and participation.
Secondary objectives
1. To determine the change in knowledge and skills in parental/caretaker after the Tier 2 interventions.
2. To determine the change in parental/caretaker level of stress after Tier 2 interventions.
3. To determine the change in parental/caretaker level of stress after Tier 3 interventions.

4. To establish the extent to which children with developmental delay and disability Tier 1 are included in ECD programmes
5. To establish the extent to which children with developmental delay and disability tier 2 are included in ECD programmes. (This could be a compliance or fidelity issue
6. To determine how well (fidelity) the health workers provided the Tier 2 and 3 interventions.
7. To determine compliance with Tier 2 and Tier 3 interventions by the caregivers.
8. To determine family satisfaction with all three tiers of the program, including both children that failed and children who passed the screening assessment (Tier I).
9. To determine the costs and cost-effectiveness of the entire program.
10. To assess the likelihood of continuation
Mubende, Kiyuni
Mubende, Kiyuni
Uganda 2025-03-04 13:40:10 2028-03-04 296 Children aged 0-3 months, Children aged 6-36 months,Children with developmental delay, at risk of Celebral Palsy and Austism UNICEF 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
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
sunday anziku oyeeson
ID:
Exploring the Teachers’ Feedback Practices and its Influence on Students’ Learning in CBC: A case of a selected secondary school in Central Division, Arua City.
REFNo: SS2007ES

To explore how teachers’ feedback influences students' learning in CBC in lower secondary schools in Arua City.
To find out how students perceive the influence of feedback on their own learning in CBC.
To examine the strategies used by teachers to administer feedback to students in CBC in lower secondary schools in Arua City.
To find out the challenges faced by teachers in administering feedback to students in CBC in lower secondary schools in Arua City.

Uganda 2023-11-16 13:34:21 2026-11-16 2 school administrators (Headteacher and Deputy), 3 Teachers of lower secondary or CBC classes (S.1, S.2, and S.3) and 9 Students in CBC classes (considering 3 students from each class) The study will be conducted in a secondary school involving CBC class students, teachers and the school administrators Self-Sponsored Social Science and Humanities Clinical Trial Degree Award
JIM ARINAITWE
ID: UNCST-2021-R012572
Quit4Life: Adapting and Evaluating a Phone-Based Tobacco Uses Cessation Program for People Living with HIV in Uganda and Zambia.
REFNo: HS1762ES

The goal of the study is to adapt and evaluate the efficacy of a phone-based tobacco cessation intervention for PLWH in Uganda and Zambia in five years. The primary objective of the study is to promote smoking cessation among HIV infected persons. Specifically, 1) adapt a standard short message service (SMS) for tobacco cessation program, 2) Nicotine Replacement Therapy, 3) compare the efficacy of our SMS-based program tailored to meet the needs of PLWH (Quit4Life+) to the current standard of care.
Arua, Adumi HCIV, Omugo HCIV and River Oli HCIV
Moroto, Loputuk HCIII, Nadunget HCIII and Tapac HCIII
Uganda 2021-12-28 2024-12-28 Total Sample size is 800 with 400 from Uganda and 400 from Zambia The study will include males and females of consenting age attending HIV services at Health III, IV, District/Regional Referral Hospitals National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
SIMON ARUNGA
ID: UNCST-2021-R013498
Cluster randomised controlled trial of a complex intervention package to reduce blindness from severe microbial keratitis in Uganda.
REFNo: HS1814ES

To determine if a complex intervention package delivered at the Primary Health Centres (PHCs) including early recognition, prompt chlorhexidine 0.2% treatment and rapid referral can result in reduced rates of blindness from severe MK at three months
Ntungamo, All parishes
Isingiro, All parishes
Uganda 2022-03-21 2025-03-21 Participants Individuals with corneal abrasions and corneal infection (microbial keratitis) presenting at the cluster primary health centres in these two districts in South Western Uganda will be elig All individuals aged 18 and above, of all sexes in the two districts London School of Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
GUMA  ASHIRAF
ID:
PREVALENCE, PATTERNS AND CORRELATES OF GENERAL JOINT PAIN AMONG PATIENTS WITH DIABETES MELLITUS ATTENDING DIABETIC CLINIC AT MBARARA REGIONAL REFFERRAL HOSPITAL
REFNo: HS3963ES

To determine the prevalence of general joint pain among patients with DM attending diabetes clinic at MRRH.To determine the patterns of joint pain among patients with DM attending diabetes clinic at MRRH.To determine the associated factors to general joint pain among patients with DM attending diabetes clinic at MRRH.
Mbarara, Rwebikona
Uganda 2024-08-29 10:59:36 2027-08-29 242 The study population will be patients with DM attending diabetes clinic at MRRH. The diabetes clinic has a patient census of approximately 1500 patients of which about 80 patients attend every week. The study population is between the age of 18 years to 90 years. Most of the study population are Banyankole, Bakiga and Bahima. The study population is made of both males and females. Guma Ashiraf, Jemba Jovane, Mwesigwa Emma, Bananuka Bernard Medical and Health Sciences Clinical Trial 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
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
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
Achilles Katamba
ID: UNCST-2019-R000540
Human-Centred Design and Communities of Practice to Improve Delivery of Home based Tuberculosis Contact Investigation in Uganda
REFNo: HS1720ES

General Objective: The study aims to assess the effectiveness of an enhanced intervention strategy for implementing TB contact investigation relative to usual care. Specific Objectives: 1.To compare the implementation, effectiveness, and public health impact of TB contact investigation delivered via an enhanced intervention strategy vs. the usual care strategy in a stepped-wedge, cluster-randomized implementation trial. 2.To identify implementation processes and contextual factors that influence the effectiveness of the intervention strategy for TB contact investigation. 3.To compare the costs and epidemiological impact of the intervention and usual care strategies for TB contact investigation.
Masaka, Ndejje
Masaka, Masaka
Butambala, Goombe
Wakiso, Wakiso
Wakiso, Ndejje
Kiboga, Kiboga
Mubende, Kasambya
Mubende, Mubende
Mityana, Mityana
Iganga, Iganga
Bugiri, Bugiri
Jinja, Jinja
Wakiso, Entebbe
Wakiso, Kasangati
Kayunga, Kayunga
Kayunga, Nagalama
Uganda 2021-09-17 2024-09-17 1764 household and close contacts within approximately 2304 eligible index patient clusters over a 16-month period. Household and close contacts of index patients with active pulmonary TB National Institute of Allergy and Infectious Diseases (NIAID) Medical and Health Sciences Clinical Trial Non-degree Award
Achilles Katamba
ID: UNCST-2019-R000540
Peer-led Implementation of TB-HIV Education and Adherence Counselling in Uganda
REFNo: HS4801ES

To evaluate the implementation fidelity and context of a peer-navigation strategy for TB-EC to improve TB treatment and ART outcomes, To determine the feasibility, acceptability, and appropriateness of a peer-navigation strategy for TB-EC and explore the social-behavioral mechanisms for improving adherence and clinical outcomes. ,To evaluate the implementation of a peer-navigation strategy for TB-EC to improve TB treatment completion and ART retention. , To evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects. ,
Kampala,
Kampala,
Kampala,
Kampala,
Jinja, Wanyange
Jinja,
Buikwe,
Iganga,
Kiboga,
Mityana,
Butambala,
Wakiso,
Wakiso,
Kayunga,
Kampala,
Kamuli,
Luweero,
Lyantonde,
Mukono,
Uganda 2024-09-10 10:03:57 2027-09-10 1920 index cases Study population in Aim 1: Our target population is adults (age ≥18) starting treatment for TB/TB-HIV in public, private, and private not-for-profit primary care clinics in Uganda. Targeting this population will allow us to assess the impact of the TB-EC on TB and ART treatment adherence and outcomes across a diverse population. Study population Aim 2: For the pilot study to test Aim 2 instruments, we will enroll adults (age ≥18) undergoing evaluation for TB and on TB treatment in primary care clinics. All participants in Aim 1 of the study will participate in the Aim 2 of the study. We administer social and behavioral scales through the surveys that will be conducted in Aim 2. Study population in Aim 3: Aim 3 participants will include a subgroup of individuals enrolled in the Aim 1 trial, their peer navigators, and healthcare workers at study sites. National Institute of health Medical and Health Sciences Clinical Trial Non-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
JUSTUS BARAGEINE KAFUNJO
ID: UNCST-2020-R014150
COMPREHENSIVE REINTEGRATION ASSISTANCE FOR WOMEN WITH FEMALE GENITAL FISTULA: INTERVENTION PILOTING
REFNo: SS890ES

Aim 1: To understand the feasibility and acceptability of a pilot reintegration program for female genital fistula. Aim 2. To assess the acceptability of the pilot reintegration intervention to patients, intervention implementors. Aim 3. To assess the preliminary effectiveness of the pilot reintegration intervention.
Kampala, MULAGO
,
Uganda 2021-06-24 2024-06-24 40 (30 women to participate in the intervention and indepth interview plus 10 stake holders Women aged 18 years and above or considered emancipated minors under Ugandan law who are undergoing genital fistula surgery. U.S. Eunice Shriver Kennedy National Institute of Child Health and Development. Social Science and Humanities Clinical Trial Non-degree Award
BRENDA GATI MIREMBE
ID: UNCST-2021-R013390
A Phase 3, Randomized, Active Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Women at High Risk for HIV 1 Infection.
REFNo: HS1631ES

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

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

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

Kampala,
Wakiso,
Mukono,
Mpigi,
Nakaseke,
Luweero,
Buikwe,
Jinja,
Gomba,
Butambala,
Kayunga,
Uganda 2021-08-27 2024-08-27 Approximately 4,500 participants will be randomized (stratified by site and age) in a 1:1 ratio to receive either ISL or FTC/TDF for the duration of the study. Approximately 50% of the global study po Cisgender female participants aged 16 to 45 years of age who are at high risk of acquiring HIV-1 infection. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Medical and Health Sciences Clinical Trial Non-degree Award
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
Bernard Kikaire
ID:
Effect of an interactive SMS system in improving the reporting of adverse drug reactions among people living with HIV in Tanzania and Uganda: a randomized controlled trial: The REMIND ADR TRIAL
REFNo: HS2922ES


To investigate the effectiveness of SMS reminders on improving ADR reporting compared to no SMS among people living with HIV in Tanzania and Kampala Uganda.
To describe the most commonly reported ADR profiles among people living with HIV in Tanzania and Uganda.
To determine the most common routes/ methods of reporting ADR used by PLHIV.
To explore the causal relationship between the commonly reported ADRs and ART.
To improve treatment options for participants who reported ADR.
To explore the technical feasibility and acceptability of the intervention in reporting ADR among PLHIV.

Kampala, mulago
Uganda 2023-08-08 12:42:32 2026-08-08 114 Age between 18 and 65 confirmed and documented HIV infection Being on ART treatment for less than one year Able to read and understand SMS Able to understand and willing to sign the informed consent document Able to read and write a text message Have a mobile phone The study is funded by Eastern Africa Consortium for Clinical Research (EACCR3) which is a network of excellence under EDCTP Medical and Health Sciences Clinical Trial Non-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
Betty Mwesigwa
ID: UNCST-2020-R014667
Sabin 003: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
REFNo: HS3628ES

To evaluate the safety and tolerability of cAd3-EBO S vaccine
Kampala, Central
Kampala, Central
Kampala, Central
Uganda 2024-02-13 17:35:43 2027-02-13 125 participants 18 to 70-year old healthy adults Sabin Vaccine Institute Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Bisegerwa
ID: UNCST-2022-R011022
Accuracy of Pulse Oximeters with Profound Hypoxia
REFNo: HS6506ES

To generate two to three evidence-based recommendations to regulatory and procurement bodies within six months of study completion to guide pulse oximeter selection for diverse populations.,To collect and contribute data on pulse oximeter accuracy across diverse skin tones to an open-access device performance database by the study’s end, enabling manufacturers to refine pulse oximeter technology and ensure equitable performance across all skin tones, especially in low-resource settings.,To replicate the UCSF Hypoxia Lab in Uganda by establishing a fully equipped and operational facility within a year to evaluate pulse oximeter accuracy across diverse skin tones and hypoxia levels.,To evaluate the accuracy of pulse oximeters under controlled hypoxic conditions in a diverse population in Uganda, with a focus on understanding and addressing disparities in device performance related to skin pigmentation.,
Kampala, Kololo
Uganda 2025-09-12 17:03:12 2028-09-12 432 This study will be done on healthy male or female participants between the ages of 18-50 years. Association of Anesthesiologists of Uganda Medical and Health Sciences Clinical Trial Non-degree Award
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