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  
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
Joseph Lutaakome
ID: UNCST-2020-R008323
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE)
REFNo: HS2703ES

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) is a master protocol being conducted in many countries around the world, and funded by the National Institutes of Health, USA. STRIVE will evaluate the safety and effectiveness of unlicensed and licensed treatments and different combinations of treatments, to improve the health outcomes of adults
hospitalised with acute respiratory infections, like COVID-19 or influenza.
Kampala, Kampala
Masaka, Masaka
Gulu, Gulu
Lira, Lira
Uganda 2023-08-08 12:39:21 2026-08-08 1,500 The participant population are non-pregnant or breast-feeding adults aged ≥ 18 years; with confirmed COVID-19 for <14 days, and requiring inpatient hospital acute medical care and with evidence of a COVID-19 lower respiratory tract infection. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
A phase 2, partially-blinded, randomised trial assessing the safety and efficacy of TBAJ876 or bedaquiline, in combination with pretomanid and linezolid in adult participants with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis
REFNo: HS2928ES

The objectives of the trial are to evaluate the efficacy, safety, and tolerability of TBAJ876 (3 doses) or bedaquiline in combination with pretomanid and linezolid in adult participants with newly diagnosed, smear-positive pulmonary DS-TB in comparison to the SOC
Kampala, Mulago
Kampala, Lubowa
Uganda 2023-08-07 15:20:08 2026-08-07 The trial is planned to randomise at least 60 participants per treatment arm, for a total of at least 300 participants randomised. Study population should have the following characteristics: 1. Signed written informed consent prior to undertaking any trial-related procedures. 2. Participants aged 18 to 65 years, inclusive. 3. Body weight (in light clothing and no shoes) ≥35 kg. 4. Sputum positive for tubercle bacilli (at least 1+ on the IUATLD/WHO scale on smear microscopy) at the trial laboratory. 5. DS-TB participants defined as the following: a. Sensitive to rifampicin and isoniazid by rapid sputum-based test (see trial Mycobacteriology Laboratory Manual) AND b. Either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB. 6. A chest x-ray during the screening period or within 14 days of screening which in the opinion of the investigator is compatible with pulmonary TB. 7. Be of non-childbearing potential OR using effective methods of birth control as defined below: Non-childbearing Potential a. Participant is not heterosexually active or practices sexual abstinence OR b. Female participant or male participant’s female sexual partner: bilateral oophorectomy, bilateral tubal ligation, and/or hysterectomy or has been postmenopausal with a history of no menses for at least 12 consecutive months OR c. Male participant or female participant’s male sexual partner: vasectomized or has had a bilateral orchidectomy at least 3 months prior to screening Effective method of birth control is defined as 1 of the following: a. Double-barrier method which can include a combination of male condom, diaphragm, cervical cap, or female condom. Note: Female and male condom should not be used together. b. Combination of a barrier method with hormone-based contraceptives or an intrauterine device. Both male and female participants must be willing to continue practicing birth control methods and not be planning to conceive throughout treatment and for 6 months after the last dose of IMP. References to male or female mean “assigned male or female at birth,” respectively. TB Alliance Medical and Health Sciences Clinical Trial Non-degree Award
Proscovia Nabunya
ID: UNCST-2019-R000970
Say No to Stigma-Round 2: Pilot testing the impact of visuals designed to reduce mental health stigma among primary school students in Uganda
REFNo: SS1818ES

Examine the acceptability and preliminary impact of the Say No to Stigma visual solutions on children’s mental health awareness and stigma in schools.
Uganda 2023-07-27 20:55:02 2026-07-27 100 One hundred (100) students in total will be recruited for this study. Inclusion Criteria: Children: 1) ages between 8 to 13 (primary 2 to 7) enrolled in the selected school. Exclusion Criteria: 1) inability to comprehend study procedures or participant rights as assessed by trained staff during the informed consent process; or 2) they are unwilling or unable to commit to completing the study. Washington University in St. Louis Social Science and Humanities Clinical Trial Non-degree Award
Grace Mirembe
ID: UNCST-2022-R008850
RV 591 entitled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults”
REFNo: HS2891ES

To assess the safety, reactogenicity and tolerability of two vaccination regimens: rapid dose-escalation of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV or co-administration of CH505 TF chTrimer+ALFQ and Ad26.Mos4.HIV
Kampala, Central
Uganda 2023-07-14 9:49:16 2026-07-14 50 Healthy male and female participants, aged 18 to 50 years The Surgeon General, Department of the Army Medical and Health Sciences Clinical Trial Non-degree Award
Joy Gumikiriza- Onoria Louise
ID:
Development of a Caregiver Centered Psychotherapy (CCPT) in addressing patient care for older persons with Alzheimer’s Disease and Related Dementias (ADRD) in Uganda.
REFNo: HS2909ES

1. To explore ways in which older people in the community of Wakiso district conceptualize ADRD and what informs their opinions. 2. To assess caregiver distress, non-professional techniques of patient care, quality of life and the associated factors among family caregivers of persons with ADRD in Wakiso district.To adapt and pre-test the WHO-iSupport for family caregivers of persons with ADRD in Wakiso, Uganda4. To determine the effectiveness of A-iSupport in the alleviation of distress among family caregivers of persons with ADRD in Wakiso, Uganda
Wakiso, Busukuma
Wakiso, Nansana
Uganda 2023-07-14 9:40:03 2026-07-14 180 All residents of Wakiso district aged 60 years and older, includidng caregivers of persons with ADRD BRAIN health Medical and Health Sciences Clinical Trial Degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO-TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER (HeredERA)
REFNo: HS2968ES

To identify and/or evaluate biomarkers that are predictive of response to Phesgo and giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to Phesgo and giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of Phesgo and giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety,To evaluate potential effects of ADAs,To evaluate the immune response to pertuzumab, trastuzumab, and rHuPH20,To evaluate the potential relationships between Phesgo and giredestrant exposure and the safety, efficacy, immunogenicity, or biomarker endpoints.,To characterize the giredestrant, pertuzumab, and trastuzumab PK profile when given in combination,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo from the participant's perspective,To evaluate health utility of participants treated with Phesgo plus giredestrant compared with Phesgo to generate utility scores for use in economic models,To evaluate effects of Phesgo plus giredestrant compared with Phesgo on work productivity and activity,To evaluate the safety of Phesgo plus giredestrant compared with Phesgo,To evaluate the efficacy of Phesgo plus giredestrant compared with Phesgo,
Kampala, Mulago
Uganda 2023-07-14 12:43:26 2026-07-14 20 This study will enrol patients with locally advanced or metastatic receptor positive breast cancer above 18 years of age La Roche Hoffman Medical and Health Sciences Clinical Trial Non-degree Award
Angella Natukunda
ID:
DETERMINANTS OF NUTRITION STATUS AMONG ADOLESCENTS IN SELECTED SECONDARY SCHOOLS OF KANUNGU DISTRICT SOUTH WEST REGION UGANDA
REFNo: SS1812ES

Broad obective To investigate the determinants of nutrition status among adolescents in selected secondary schools in Kanungu District South West Uganda. Specific objectives To assess the nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the social demographic and economic factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the diet-related factors influencing nutrition status of adolescents in the selected secondary schools of Kanungu District South West Region Uganda. To determine the level of adolescent nutrition knowledge associated with nutrition status among adolescents in the selected secondary schools of Kanungu District South West Region Uganda.
Uganda 2023-07-14 12:34:44 2026-07-14 370 The study population will constitute of adolescents both male and female studying in secondary schools of Kanungu district 12 to 19 years. Natukunda Angella Social Science and Humanities Clinical Trial Degree Award
Rhoda Wanyenze
ID: UNCST-2021-R013352
A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention (GC-CCP) in Uganda
REFNo: SS1873ES

1. Conduct a multisite RCT of the GC-CCP network-based advocacy strategy to evaluate effects on CC screening uptake, access to early-stage treatment and prevention of advanced disease among unscreened alters across urban/rural and public/private clinics,4. Evaluate the cost-effectiveness of Implementing GC-CCP to increase CC screening and low cost, early-stage treatment, and prevent advanced disease, compared to enhanced usual care.,3. Examine mediators and moderators (among index, alter and network characteristics) of intervention effects on (a) alter CC screening; and (b) engagement in CC prevention advocacy of index and alter (1st and 2nd degree) to better understand its multiplier effect on diffusion of advocacy throughout a network.,2. Use a mixed methods approach (semi-structured interviews and administrative clinic data) to examine clinic-, provider-, and client-level barriers and facilitators of GC-CCP Implementation and Sustainment.,
Kampala, Nsambya
Kampala, Kawempe
Buikwe, Buikwe
Kayunga, Kayunga
Uganda 2023-07-13 11:13:19 2026-07-13 1400 women Women recently screened for Cancer of the Cervix and aged 25 years and above will be enrolled as index participants, Women who have not screened for Cancer of the Cervix but are network members of index participants will be enrolled as alter participants, Clinic leadership and providers of Cervical Cancer services will participate in qualitative interviews. National Institute of Mental Health Social Science and Humanities Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (Lidera)
REFNo: HS2193ES

Main Objective

1. To demonstrate superiority of giredestrant over the control treatment.
Specific Objectives

1. To evaluate the efficacy of giredestrant compared with Therapy of Physician's Choice
2. To evaluate the safety of giredestrant compared with Therapy of Physician's Choice
3. To characterize giredestrant Pharmacokinetics
4. To evaluate health status utility scores of participants treated with giredestrant compared with Therapy of Physician's Choice
5. To evaluate the tolerability of giredestrant compared with Therapy of Physician's Choice
6. To identify and/or evaluate biomarkers that are predictive of response to giredestrant (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to giredestrant, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of giredestrant activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety
Kampala, Mulago
Uganda 2023-07-13 10:07:44 2026-07-13 18 women aged 18 years of age and over with histologically confirmed breast cancer Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children.
REFNo: HS2931ES

The primary objective of this study is to confirm the dose of B/F/TAF FDC in HIV-1 infected pediatric participants, to confirm the dose of B/F/TAF TOS in HIV-1 infected pediatric participants and to evaluate the safety and tolerability these medications.
Kampala,
Uganda 2023-07-06 17:23:47 2026-07-06 5 Adolescents and children Gilead Sciences Medical and Health Sciences Clinical Trial Non-degree Award
Thomas McHale
ID: UNCST-2022-R008812
Optimizing the Dose of Flucytosine for Cryptococcal Meningitis
REFNo: HS2940ES

Determine if 50 mg/kg/day of 5-FC has a similar mortality benefit compared to 100 mg/kg/day,Reduce the cost and supply burden of treating an individual with cryptococcal meningitis,Determine if 50 mg/kg/day of 5-FC is a safer dosage compared to 100 mg/kg/day of 5-FC,Determine if 50 mg/kg/day of 5-FC is has a similar rate of cryptococcal clearance from CSF compared to 100 mg/kg/day,Determine the optimal dose of 5-FC for for management of induction phase of therapy for cryptococcal meningitis,
Kampala,
Mbarara,
USA 2023-07-05 11:41:24 2026-07-05 The target sample size is 50 participants The study will enroll adults with HIV who are over 18 years old and sick with cryptococcal meningitis. National Institute of Health, United States Medical and Health Sciences Clinical Trial Degree Award
Daniella Akellot
ID:
EVALUATION OF THE EFFECTIVENESS OF CLORPACTIN IN COMPARISON WITH OTHER WOUND DRESSING AGENTS USED AT SIGN SUPPORTED HOSPITALS IN UGANDA
REFNo: HS2769ES

To determine the effectiveness of Clorpactin in wound dressing at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor.,
Kumi, Booma South
Gulu, ForGod
Uganda 2023-07-03 13:32:54 2026-07-03 546 patients Patients admitted at Kumi Orthopaedic Center and St. Mary’s hospital, Lacor with surgical wound sepsis, infected open fractures, diabetic wounds, chronic osteomyelitis. SIGN Fracture Care International Medical and Health Sciences Clinical Trial Non-degree Award
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
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