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  
Christine  Muhumuza
ID: UNCST-2023-R008646
 Improving Family Wellness for Couples in Central Uganda 2024-2029
REFNo: HS5523ES

The study aims are to:

(1) In a cluster randomised trial, compare the efficacy of the FH=FW intervention vs. a time/attention matched comparator intervention at increasing modern contraceptive use and reducing unintended pregnancy among couples with an unmet need for family planning through 24-months, and identify potential mediators of the intervention effect.

(2) Determine the intervention’s effect on, and determinants of, contraceptive continuation.

(3) Through a mixed-methods process evaluation, explore factors affecting the implementation of the intervention in order to improve feasibility, acceptability, and the likelihood of future adoption and sustainment
 Kalungu, Kalungu
Gomba, Kinoni
Mpigi, Bulunda A
Kalungu, Lukaya
Gomba, Kisozi
Mpigi, Muduma
Kalungu, Kabungo
Kalungu, Bbaala
Kalungu, Kabale
Kalungu, Kalungi
Kalungu, Kasambya
Kalungu, Kabungo
Gomba, Bulwadda
Gomba, Kasaka
Gomba, Kyayi
Gomba, Bukalagi
Gomba, Mpenja
Gomba, Ngomanene
Mpigi, Bunjako
Mpigi, Mitala-Maria
Mpigi, Butoolo
Mpigi, Kampiringisa
Mpigi, Katende
Mpigi, Sekiwunga
Mpigi, Kitakyusa
Mpigi, Nsamu/Kyali
Mpigi, Bujuuko/Bulamu
Mpigi, Nindye
 Uganda 2025-02-20 17:09:28 2028-02-20 We will sample 4 health centers (clusters) in each of the 3 districts. We expect that the 12 clusters will yield ~1704 participants (852 couples) across the two study arms. Married men and women (couples) aged 18-49 of any tribe in the selected districts. National Institute of Child Health and Development (NICHD), grant number: R01HD113806 Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Muhanguzi
ID: UNCST-2019-R001101
 Evaluation of the Safety, Efficacy and Stability of SangaSupa®-30% Emulsifiable Concentrate [EC]: A Randomised Single-Blinded Positive Controlled Multi-Site Acaricide Field Trial
REFNo: NS910ES

General objectives
To determine the efficacy, safety, and stability of SangaSupa® (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 determine;-
i. efficacy of SangaSupa® when applied onto cattle by hand spraying and plunge dipping for tick control.
ii. safety of Sangasupa® when applied onto cattle by hand spraying and plunge dipping for tick control.
iii. Stability of Sangasupa® when applied onto cattle by plunge dipping for tick control.
Kyenjojo, Ntuutu
Kyenjojo, Ruhoko
Kyenjojo, Hima
Serere, Bugondo
Serere, Okidi
Kumi, Kachaboi
 Uganda 2025-02-14 15:53:01 2028-02-14 n = 797 cattle above three months. For details please refer to the protocol Cattle above 3 months , both male and female. All cattle breeds will be eligible for recruitment. The detailed inclusion and exclusion criteria are described in the main protocol. The Government of Uganda Natural Sciences Clinical Trial Non-degree Award
Joseph  Matovu KB
ID: UNCST-2020-R014654
 Reducing hazardous alcohol use and optimizing treatment as prevention among men living with HIV in risk environments
REFNo: HS5558ES

Understand barriers and facilitators in the inner and outer context for implementing the components of Kisoboka within the routine clinical setting to inform future widespread implementation guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework and documentation of intervention and implementation costs. ,Assess the impact of the Kisoboka intervention and its components on measures of psychological, physical, and socioeconomic well-being that capture frequent comorbidities of people living with HIV and are associated with achieving successful treatment as prevention,Determine the efficacy of the Kisoboka intervention and its components on alcohol and HIV outcomes among hazardously drinking men living with HIV in Uganda in a 2x2 factorial RCT. ,Assess the efficacy of Kisoboka and its components (BE & MI) to gain insight into Kisoboka’s potential effect, determine if BE and MI interact and examine barriers and facilitators for implementing Kisoboka within routine clinical settings to inform future widespread implementation.,
 Buikwe, Kawolo
Buikwe, Buikwe Mbiko
Buikwe, Nyenga
Buikwe, Ngogwe
Buikwe, Buikwe Ssi
Buikwe, Makonge
Buikwe, Buikwe Njeru
Nakasongola, Nakasongola Town
Nakasongola, Lwampanga
Nakasongola, Kalungi
Nakasongola, Nabiswera
Nakasongola, Nakayonza
 Uganda 2025-02-14 15:19:41 2028-02-14 820 Eligibility is men aged ≥18, living with HIV, residing in a fishing community (on most days/nights), AUDIT-C positive (≥4) indicating potential hazardous alcohol drinking and >6 months since initial ART initiation, last VL was detectable or missing, not planning to move from the area within the next 6 months and have their own mobile phone and can be reached via phone. National Institute of Health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
David Mukunya
ID: UNCST-2022-R010707
 A phase III, randomized, open-label, clinical trial to evaluate the safety and efficacy of emollient therapy for very low birthweight infants (<1500g) in Uganda in promoting survival, health, growth and development compared to no emollient treatment
REFNo: HS5338ES

To evaluate the efficacy of emollient therapy with SSO – compared to standard care without use of emollients – among hospitalised very low birth weight (VLBW, <1500g) infants in Uganda on: the rate of in-hospital mortality, serious infections, hypothermia, growth, intraventricular haemorrhage, and skin condition; maternal depression and anxiety; maternal and neonatal interaction; infant growth and neurodevelopment at 12 month corrected age (chronological age reduced by the number of weeks born before 40 weeks of gestation); and infant mortality.
Mbale, Hospital Cell
 Uganda 2025-01-31 7:21:53 2028-01-31 1242 Preterm infants who are admitted to MRRH-NNU. Inclusion criteria: • Admission weight 800g to <1500g • Admission age < 24 hours • Mother +/- father who can understand English, Luganda, Lugwere, Ateso or Lumasaba • Mother +/- father who are willing and able to give verbal consent for participation of their infant in the study. • Mother aged 15 years or above Exclusion criteria: • Mother or father are not willing or are unable to give written, informed consent for participation of their infant in the study within 48 hours of admission to the NNU • Second or later birth order or a multiple pregnancy, when the first or an earlier birth order infant is eligible for participation • Infants with major congenital abnormality e.g. gastroschisis, cyanotic heart disease, upper airways abnormality • Critically ill infants at time of enrollment: Babies with apnoeas requiring frequent stimulation or bag mask ventilation; shock (heart rate >200 beats per minute and/or Mean Arterial Pressure <Gestational Age); Severe respiratory distress (Downs Score ≥8); Respiratory Failure (Oxygen saturation <90% on oxygen therapy/bCPAP) • Infants with generalized skin disease or a structural defect involving >5% body surface area likely to produce a defect in epidermal barrier function. • Mother and father unwilling to come back to Mbale RRH for follow-up Mbale Clinical Research Institute Medical and Health Sciences Clinical Trial Non-degree Award
JUDITH NASSAAZI
ID: UNCST-2023-R007664
 Comparing in-person versus virtual postoperative review appointments for children following guided growth surgery at CORSU Hospital, Uganda
REFNo: HS5268ES

Study Objectives
Primary objectives
To compare the show-rates of in-person versus virtual/telehealth post-operative review appointments for children following guided growth surgery at CoRSU Hospital

Secondary objectives.
1.To compare parental satisfaction of in-person versus virtual appointments
2.To determine the factors that facilitate in-person and virtual appointments following guided growth surgery.
3.To compare the rate of post-operative complications following in-person follow-up versus virtual follow-up
 Wakiso, KISUBI
 Uganda 2025-01-22 10:12:27 2028-01-22 82 FROM AGE 3 TO 12 IN GIRLS AND 3 TO 16 IN BOYS ALL TRIBES AND BOTH MALES AND FEMALES ARE INCLUDED IN THE STUDY SELF SPONSORED AND PARTIAL FUNDING BY UNIVERSITY OF CARLIFORNIA SANFRANCISCO Medical and Health Sciences Clinical Trial Non-degree Award
Justine Namuli Diana
ID: UNCST-2021-R011844
 ENHANCING COMPREHENSION OF INFORMED CONSENT IN RESEARCH INVOLVING PATIENTS WITH PSYCHOTIC DISORDERS USING AUDIO-VISUAL AIDS
REFNo: HS5358ES

To evaluate the comprehension of informed consent, identify key factors that are associated with comprehension of consent, determine the feasibility, acceptability, and preliminary effectiveness of audio-visual aids on enhancing the comprehension of consent information during the consenting process in research involving individuals with psychotic disorders
 Kampala, Butabika
 Uganda 2025-01-10 12:00:57 2028-01-10 study 1=418, study 2,8 participants, study 3,60 participants,study 4 not less than 18 Ugandans aged 18 years and above, all gender Makerere University international bioethics research training PhD program (GRANT NUMBER D43TW010892) Medical and Health Sciences Clinical Trial Degree Award
Francis Ssali
ID: UNCST-2021-R012134
 A5409: A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)
REFNo: HS4036ES

1.2 Primary Objectives

1.2.1 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for each experimental treatment arm to the SOC arm.

1.2.2 To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3 Secondary Objectives

1.3.1 To compare time to stable culture conversion by MGIT liquid culture by week 8 for each experimental treatment arm to the SOC arm.

1.3.2 To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.3 To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.4 To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26 weeks of treatment for each experimental treatment arm to the SOC arm.

1.3.5 To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.

1.3.6 To compare a composite of efficacy and safety outcomes using a risk-benefit approach for each experimental treatment arm to the SOC arm.

1.3.7 To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.

1.3.8 To compare durable cure by 52 weeks after treatment initiation in each experimental treatment arm to the SOC arm.


 Kampala, Kampala
Wakiso, Wakiso
 Uganda 2024-12-23 12:34:14 2027-12-23 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm. The JCRC site plans to recruit at least 50 participants Participants with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. National Institute of Allergy and Infectious Diseases (NIAIDS) Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
 A Phase 1b, Age De-Escalation/Dose Escalation Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in an African Population of Adults and Children in a Setting of Perennial Malaria Transmission
REFNo: HS5298ES

Primary Objective. To assess the safety and tolerability of MAM01. Secondary Objectives. To assess the safety of MAM01. To characterize the PK of MAM01 following SC, IV, and IM administration of MAM01. To assess the formation of anti-drug antibodies (ADAs) to MAM01. Exploratory Objectives. To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to a placebo. To assess the protective efficacy of a single dose of MAM01 over 182 days against Pf infection, as detected by blood smear microscopy compared to placebo. To assess the protection of MAM01 against events of malaria illness (first/only and all episodes). To correlate MAM01 concentration with Pf infection risk. To assess the complexity of Pf infection following administration of MAM01 or placebo.
Tororo, Osukuru
Tororo, Kayoro
Tororo, Magola
Kampala, Lubowa
 Uganda 2024-12-23 12:23:27 2027-12-23 139 Adults and children, male and female Bill & Melinda Gates Medical Research Institute (Gates MRI) Medical and Health Sciences Clinical Trial Non-degree Award
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
 A phase III, Multicenter, Randomized, Placebo Controlled, Double blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5365ES

To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52 week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the Screeening visit
To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period: • VOCs that are HCP-managed at a health care facility • VOCs that are HCP-managed via remote consultation • VOCs that are self-managed without recommendations from HCP during the event • VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event
To evaluate the time to first VOC that is HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
 Eastern Region, All parishes
 Uganda 2024-12-23 11:34:49 2027-12-23 315 Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to <18 years old and adults include participants aged 18 years and older. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Solomon Kibudde
ID: UNCST-2021-R013747
 PHASE II RANDOMIZED NON-INFERIORITY TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOR LOCALLY ADVANCED CERVICAL CANCER IN UGANDA.
REFNo: HS5348ES

1) To compare the incidence of grade 3+ gastrointestinal and genitourinary toxicity at 1 year post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) and conventional fractionated radiotherapy (45 Gy in 25 fractions) in women with cervical cancer in Uganda.
2) To evaluate and compare local control and cervical cancer-specific survival rates at 1 year after hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional radiotherapy (45 Gy in 25 fractions).
3) To determine the association between stage-adjusted mean squamous cell carcinoma antigen (SCC-Ag) at 1-month post-treatment with the Progression-free survival at 1- year post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) or conventionally fractionated radiotherapy (45 Gy in 25 fractions).
4) To compare the costs of healthcare to patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).
5) To evaluate patient-reported outcomes and quality of life in patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).

 Kampala, Mulago
 Uganda 2024-12-23 11:01:22 2027-12-23 120 participants To be considered eligible for this study, participants must meet the following criteria: 1. Females aged 18 years or older 2. Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment. 3. FIGO 2018 Stage IB3, IIA, IIB, IIIA, IIIB, IIIC, or IVA. 4. Able to provide written informed consent in English, Luganda, Runyankole, Lango or Lusoga. 5. Willing to attend post-treatment follow-up for up to 12 months. 6. Fit for concurrent chemotherapy with cisplatin. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2. 8. Adequate bone marrow function: Absolute neutrophil count ≥ 1,500 cells/mm3 (1.5 x 109/L); Platelets ≥ 100,000 cells/mm3 (100 x 109/L); haemoglobin ≥ 9.0 g/dL; Leukocyte count ≥ 4,000 cells/mm3 (4.0 x 109/L). 9. Adequate renal function: creatinine clearance > 60 mL/mins, calculated using the Cockcroft-gault equation for women. 10. Adequate liver function: AST and ALT < 3 times the upper limit of normal (ULN); and Total bilirubin < 2 x ULN unless attributed to the use of antiretroviral therapy (ART). Exclusion criteria Participants will be excluded from the study if they meet any of the following criteria: 1. Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the radiotherapy field, and dose prescriptions because they tend to have a higher risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention. 2. Clinical and/or radiological evidence of distant metastases. 3. Prior pelvic or abdominal radiotherapy. 4. Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment. 5. History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment. 6. Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may result in fetal malformations, growth retardation, or even fatal death. Secondly, their physiological changes alter the pharmacokinetics and pharmacodynamics of concurrent chemotherapy. Therefore, to protect the health of the mother and the unborn child, pregnant women will be excluded from the study. Patients who are found to be pregnant after enrollment will have the study procedures terminated. 7. Concurrent untreated invasive malignancy 8. Uncontrolled concurrent medical/psychiatric diagnosis that would limit compliance with study requirements Uganda Cancer Institute, Varian Medical Systems, and UCI-FHCC Medical and Health Sciences Clinical Trial Degree Award
Jackson Orem
ID: UNCST-2021-R012016
 A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings
REFNo: HS4073ES

To describe the incremental cost-effectiveness ratio per QALY gained (as assessed by PROPr) between PLD and PTX,To assess quality of life across PROMIS domains (i.e., cognitive function, physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) with the PROPr tool at start of therapy, mid-treatment, and after treatment with PLD and PTX ,To describe the cost of therapy across AMC sites in sub-Saharan Africa to deliver both PLD and PTX by micro-costing analysis for goods and time-in-motion analysis for services. ,To estimate the objective response rate (defined as the sum of complete and partial responses) for AIDS-KS, response duration and overall survival in each treatment arm. ,To evaluate whether there is sufficient evidence to conclude that PLD is non-inferior to PTX in people with severe AIDS-associated KS receiving concomitant ART in resource-limited settings. ,
 Kampala, Mulago
Uganda 2024-12-10 14:39:24 2027-12-10 130 participants overall and up to 40 participants in Uganda This study will be done in adults above 18 years, both male and female of all tribes, and will recruit participants with HIV-associated Kaposi Sarcoma in Uganda. AIDS Malignancy Consortium Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 Open-label, Multicenter Immunogenicity and Safety Trial of MVA-BN® Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections
REFNo: HS5281ES

To assess immunogenicity of the MVA-BN standard regimen in eliciting neutralizing antibodies against vaccinia virus in children compared to adults. To assess the safety and reactogenicity of the MVA-BN standard regimen in children and adults. To assess neutralizing antibody response to the MVA-BN standard regimen. To assess durability of neutralizing antibody response to the MVA-BN standard regimen.
Wakiso, Entebbe
Mbarara, Mbarara
 Uganda 2024-11-22 17:19:29 2027-11-22 300 Participants The trial population for this trial will be both pediatric (2 to <12 years of age) and adult (18 to 50 years of age) healthy volunteers. Both males and females will be recruited at the research sites in Entebbe and Mbarara. Potential volunteers will be approached in their communities, given information about the trial and those who show interest will be requested to come to the research sites. Bavarian Nordic A/S and funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssinabulya
ID: UNCST-2021-R004352
 ImpleMEntation of a Digital-first care deLiverY model for heart failure in Uganda (MEDLY Uganda)
REFNo: HS4581ES

In this study, we will implement a digital-first, multi-component strategy for HF (Medly Uganda) and evaluate both implementation and clinical outcomes. The primary objective is to assess the implementation and clinical effectiveness of a digital-first implementation strategy to improve HF self-care in Uganda. We will conduct a stepped-wedge, cluster randomized trial in outpatient departments at 6 Ugandan RRH. The co-primary outcomes will be the Self-Care of HF Index (implementation) and the composite of mortality and HF hospitalization (clinical effectiveness). The secondary objectives will include the following. Conduct a mixed method process evaluation to inform iterative adjustments to the implementation process. We will use a community-engaged approach to systematically collect qualitative and quantitative process data at pre-determined time points based on the Learn-As-You-Go design and make contextually appropriate implementation adaptations. Prior to recruitment, we will also explore patients’ journeys to heart failure diagnosis in Uganda through a qualitative component by conducting in-depth interviews. The aims of this work will be to explore factors associated with patient’s journeys to heart failure diagnosis, including descriptions of initial symptoms, progression, health care referral journey, barriers and facilitators to care, and role of health education and self-care awareness. We will assess the implementation fidelity and sustainability of Medly Uganda with a focus on reach, adoption, and maintenance. Using Medly Uganda meta data from patients (app) and providers (dashboard), we will identify patterns and predictors of usage. We will interview patients and providers to explore these findings, and ensure implementation fidelity. We will also explore patient and provider perspectives on the sustainability of Medly Uganda, using semi-structured interviews to explore patient and provider barriers and facilitators of long-term use, to surface strategies that would optimize Medly Uganda implementation over time. We shall explore cost, cost effectiveness, and sustainability factors for Medly Uganda. We will collect and examine cost data from patients and facilities examining the unit cost (cost per HF patient treated and per HF patient controlled) of control and Medly Uganda scenarios both from a financial and societal perspective. Primary outcomes for cost effectiveness analysis will be the Incremental Cost-Effectiveness Ratio per patient treated and per death averted.
Arua,
Lira,
Mbale,
Masaka,
Mbarara,
Kabarole,
Uganda 2024-11-18 22:56:37 2027-11-18 576 We will consecutively recruit patients 18 years or older presenting for HF care at the medical outpatient NCD and/or cardiac clinics at the 6 participating sites, each a Ugandan public sector Regional Referral Hospital (RRH) located in Arua, Fort Portal, , Lira, Masaka, Mbale and Mbarara. For the secondary objectives 1 and 2 of this study, we will recruit patients, implementers and administrators to participate in the process evaluation, and in reflections on implementation and sustainability. We expect to recruit 12 implementers (2/site at minimum), 22 administrators (2/site, 6 regional representatives, and 4 MoH) as well as 72 patients (8-12 at minimum/site) for qualitative assessment over the course of the study. Our qualitative component will recruit patients 18 years or older with recently diagnosed HF (within past three months), presenting for care at Uganda Heart Institute, or Arua, Masaka, and/ Mbale RRH. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Deo Wabwire Ogema
ID: UNCST-2021-R013932
 A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB) Version 2.0, Dated 21 Mar 2024
REFNo: HS5088ES

Primary objectives

(i)To compare Mycobacterial Growth in Tube (MGIT) liquid culture Time to Positivity (TTP) slope over the first 6 weeks of treatment for each experimental treatment arm to the standard of care (SOC) arm.

(ii)To compare new Grade 3 or higher adverse events (AEs) (safety) over the first 8weeks of treatment for each experimental treatment arm to the SOC arm.

Secondary Objectives

i)To compare time to stable culture conversion by MGIT liquid culture by week 8
for each experimental treatment arm to the SOC arm.

ii)To compare MGIT liquid culture TTP slope over the first 8 weeks of treatment for
each experimental treatment arm to the SOC arm.

iii) To compare new Grade 3 or higher AEs (safety) over 26 weeks of treatment for
each experimental treatment arm to the SOC arm.

iv) To compare discontinuations of anti-TB drugs for any reason prior to 8 and 26
weeks of treatment for each experimental treatment arm to the SOC arm.

v) To determine the dose- and exposure-response relationships between experimental drug estimated pharmacokinetic (PK) parameters with safety and efficacy.
vi) To compare a composite of efficacy and safety outcomes using a risk-benefit
approach for each experimental treatment arm to the SOC arm.

vii) To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for Arms 3A-3B and Arms 4A-4B compared to Arm 2.

viii) To compare durable cure by 52 weeks after treatment initiation in each
experimental treatment arm to the SOC arm.

 Kampala, Mulago
 Uganda 2024-11-13 18:02:04 2027-11-13 315 participants Participants will be individuals (male and female) with Xpert MTB/RIF positive drug-susceptible pulmonary TB, living with and without HIV, aged ≥18 years. Pregnant women will be excluded from the study. US National Institute of Allergy and Infectious Diseases. Medical and Health Sciences Clinical Trial Non-degree Award
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
 Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial
REFNo: HS5151ES

To evaluate the cost-effectiveness of the PPH treatment with HSC compared to PPH treatment with oxytocin, if HSC is proven non-inferior. ,To evaluate the comparative effects of HSC versus oxytocin on haemodynamic outcomes when used for PPH treatment in women receiving HSC for prophylaxis; ,The primary objective of this trial is to evaluate whether HSC is non-inferior to oxytocin for treatment of PPH in women who receive HSC for PPH prophylaxis, in the prevention of additional blood loss of 500 ml or more at 90 min following randomization. ,
 Kampala, Kawempe
 Uganda 2024-11-13 17:36:53 2027-11-13 700 Pregnant women aged 15 years and above UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) Medical and Health Sciences Clinical Trial Non-degree Award
Ezekiel Mupere
ID: UNCST-2024-R003962
 A Randomized Clinical trial: Supplemental choline to prevent and treat learning and memory deficits of early iron deficiency. The SupCHO study
REFNo: HS4915ES

Conduct a randomized, placebo-controlled clinical trial to test whether nine months of daily choline supplementation improves hippocampus-dependent neurobehavioral outcomes in 6-month-old infants with iron deficiency anemia.,
 Kampala, Mulago 1
 Uganda 2024-11-13 16:35:35 2027-11-13 300 The study population will comprise infants aged 6 months (±28 days), recruited from pediatric immunization clinics at Mulago National Referral Hospital and Kawempe National Referral Hospital in Uganda. Participants will include both male and female infants, ensuring a balanced representation of sex in the study. The infants will belong to various tribes within Uganda, reflecting the diverse ethnic composition of the country. However, no specific tribe will be excluded, and the study aims to capture a broad spectrum of ethnic backgrounds to ensure the generalizability of the findings. The inclusion criteria will focus on infants with hemoglobin (Hb) levels between 7.0 g/dL and <11.0 g/dL, who are malaria-negative based on a rapid diagnostic test (RDT), and whose mothers are HIV-negative. Exclusion criteria include infants with developmental disorders, severe malnutrition, known sickle cell disease, neurological disorders, or brain injury. Thrasher Research Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Esther Buregyeya
ID: UNCST-2020-R014116
 Secondary distribution of HIV self-testing by Female Sex Workers, pre-exposure prophylaxis (PrEP) starter packs and brief counseling to promote PrEP initiation and persistence among high-risk men in Uganda
REFNo: HS4891ES

Determine acceptability, feasibility, and safety of the intervention, and preliminary estimates of the potential for the intervention, compared to the control, to promote PrEP initiation, adherence, and persistence among male clients,Conduct an initial (stage 1a) small pilot of the intervention and refine it in preparation for the stage 1b pilot trial,Create the proposed Kayungirizi intervention to promote PrEP initiation and persistence among male clients of FSW through qualitative research informing adaptation and integration of components of local models and aspects of evidence-based interventions,Our overall hypothesis is that secondary distribution of HIVST by FSW to their male clients as an entry point to generate demand for PrEP, followed by an FSW-led intervention to address ongoing structural, interpersonal, and individual-level barriers (convenience, confidentiality/stigma, flexibility) will promote PrEP initiation, adherence, and persistence among male clients. ,
 Kampala, Bwaise
Kampala, Bwaise
 Uganda 2024-10-31 17:21:44 2027-10-31 140 Both male clients of Female Sex Workers (FSW) and the FSW Age 18+ National institute of health (NIH) Medical and Health Sciences Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
 A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, with or without Tiragolumab, in Patients with Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMBRAVE152)
REFNo: HS5026ES

To evaluate the immune response to tiragolumab and atezolizumab,To characterize the PK profile of atezolizumab plus bevacizumab plus tiragolumab, To evaluate the safety of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab,To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab,
 Kampala, Mulago II
 Uganda 2024-10-14 8:13:47 2027-10-14 10 Patients diagnosed with hepatocellular carcinoma above 18 years of age Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
Wilfred Opobo
ID:
APPROPRIATENESS OF MALARIA CONTROL POLICY AND FACTORS ASSOCIATED WITH PUBLIC COMPLIANCE IN GULU DISTRICT, UGANDA. A QUALITATIVE STUDY
REFNo: SS3130ES

General objective of the study.
• To examine the factors that influence citizens’ compliance with malaria control policy guidelines in Uganda.

Specific objectives of the study.
• To explore how lay perceptions and understandings of malaria control and prevention measures influence citizens’ compliance with malaria control policy.
• To examine the effectiveness of the national information, education, and communication strategies used to promote citizens’ compliance with malaria control policy guidelines.
• To assess the effectiveness of the district malaria governance structures in promoting citizens’ compliance with malaria control policy guidelines.

Gulu, Paduny
 Uganda 2024-10-08 17:44:59 2027-10-08 50 participants initially Target population. The target population for this study encompasses the residents of Gulu district, as well as the governance structures involved in malaria control interventions within the district. Gulu district is predominantly inhabited by the Acholi tribe. However, study participants from the governance structures such as district local government and ministry of Health come from across Uganda. it is also worth mentioning that increasing urbanization is also making the district more cosmopolitan. The study population will be both male and female from the age of 18 years and above. Self sponsorship Social Science and Humanities Clinical Trial Degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
 SMART (Smallpox vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
REFNo: HS4726ES

Co-Primary objectives Co-primary: 1) To assess the effectiveness of the Smallpox vaccine in preventing RT-PCR confirmed Mpox infection among contacts of confirmed Mpox infection 2) To assess the effectiveness of the Smallpox vaccine in reducing the severity of symptoms; measured as symptom severity score, based on 12 symptom items (16) each assigned a score of 0 to 5 for a total measure of 0 to 60. These co-primary objectives will be evaluated during the first 28 days after randomization.
 Kisoro, Rubanda
 Uganda 2024-09-27 14:06:23 2027-09-27 1560 10 years and above, Males and females, and all tribes residing within the study area that meet the inclusion criteria will be included in the study. McMaster University Medical and Health Sciences Clinical Trial Non-degree Award
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