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  
Nelson Sewankambo K
ID: UNCST-2020-R014578
Evaluation of an Information Management and Communication System for Population-wide Point-of-Care Infant Sickle Cell Disease Screening (SIMCS)- A Cluster Randomized Trial
REFNo: HS6567ES

(ii) To evaluate the impact of the SCD SIMCS on access to screening and care and outcomes of children with SCD,
Jinja, Kakindu
Iganga,
Mayuge,
Kayunga,
Uganda 2025-12-05 18:30:02 2028-12-05 60 Health centers Infants aged 4-6 months National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
Safety, preliminary efficacy, and Pharmacokinetics of Herbal/Natural/ Traditional therapeutic products for the management of Diabetes Mellitus in Uganda.
REFNo: HS6530ES

Main Objective
1. To evaluate the safety, effectiveness and pharmacokinetics of 3 selected NDA- notified herbal/natural/traditional therapeutic products in Uganda, designated IMP1, IMP2, and IMP3.
2. To explore the experiences of innovators, researchers, implementers, and participants involved in this study on the innovation and scientific evaluation of natural therapeutics in Uganda.

Specific Objectives
1. To determine the efficacy of selected NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the treatment of diabetes mellitus in adult patients in Uganda
2. 2. To assess the effect of the selected NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) on specific cardio-metabolic characteristics of adult patients with DM in Uganda.
3. To assess clinical and laboratory adverse events associated with selected NDA- notified herbal/natural/traditional therapeutic products, specifically IMP1, IMP2 and IMP3 in adult patients with DM in Uganda.
4. To investigate the pharmacokinetic profile(s) of NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the management of DM.
5. To explore the experiences of innovators, researchers, implementers, and participants involved in this study on the innovation and scientific evaluation of herbal/natural/traditional therapeutics in Uganda.e the pharmacokinetic profile(s) of NDA-notified herbal/natural/traditional therapeutic products (IMP1, IMP2 and IMP3) used in the management of DM.

Uganda 2025-12-01 14:19:22 2028-12-01 424 Objective 1- 4 Persons with a new or known diagnosis of diabetes mellitus Objective 5 Personnel working in research programs, including: Investigators, Program managers, Clinical staff Innovators of herbal/natural/ traditional therapeutic products purposed for diabetes mellitus management. Objective 1-4 Adult (≥18 years) patients with recently diagnosed diabetes mellitus (diagnosis made in the preceding three months) Objective 5 Individuals who have worked with the CONAT program as investigators, program manager, or clinical staff for at least six months. Innovators of herbal/natural/ traditional products for diabetes mellitus whose product will be found during the survey. Government of Uganda-STI-OP Medical and Health Sciences Clinical Trial Non-degree Award
Sarah Wilker
ID: UNCST-2025-R019791
One size fits all? Towards individual prediction of treatment success for posttraumatic stress disorder in post-conflict settings (TRAUMA-FIT)
REFNo: HS6712ES

Main Objective 1. to identify individual predictors of treatment response to two different treatments in survivors with PTSD in a post-conflict setting Specific Objectives 1. Investigate whether NET is, on average, more effective than PM+ for the treatment of PTSD 2. Identify predictors of optimal response in the two conditions, and thereby identify predictors of treatment success in a trauma-focused versus present-focused treatment 3. Investigate the explanatory role of socio-ecological factors in PTSD treatment response
Gulu,
Germany 2025-11-26 14:28:24 2028-11-26 660 (1) Adults of Age between 18 and 65; men and women, Acholi tribe (2) Survivor of trauma related to the LRA conflict or ongoing violence in the post-conflict setting; and (3) Probable diagnosis of PTSD according to DSM-5 (PSSI-5). German Research Foundation Medical and Health Sciences Clinical Trial Degree Award
MALLON TUSUUBIRA
ID: UNCST-2025-R021850
SURVEY ON PARATUBERCULOSIS IN SLAUGHTERED GOATS AT KAMPALA CITY ABATTIOR
REFNo: A654ES

General objective
To establish the prevalence of Mycobacterium avium subsp. paratuberculosis infection in goats
Specific Objectives
i. To determine the prevalence of the gross and microscopic lesions associated with paratuberculosis in the ileocecal junction and associated lymph nodes of goats slaughtered at Kampala city abattoir
ii. To establish the prevalence of Mycobacterium avium sub species paratuberculosis in suspected cases using polymerase chain reaction (PCR)

Wakiso, Kampala
Uganda 2025-11-21 14:36:09 2028-11-21 The sample size required will be calculated by using the formula of the estimation of prevalence in a population (Thrusfield et al., 2018). n = Z².p.(1-p)/d² Where: • n = sample size required • Z = Z-value (1.96 at a 95% confidence interval) • p = expected prevalence (According to standard epidemiologic practices 50% will be used since the prevalence is unknown). (Thrusfield, 2018; Dohoo et al,2009) • d = precision (5%) n = 1.96².0.5. (1-0.5)/0.05² = 384 The samples will be obtained from Kampala city Abattoir, a large goat slaughter house along the old Port Bell Road. The samples will be analysed in the histopathology research laboratory (CDL) and the pathology Laboratory, SVAR Makerere University. The study population will be goats that are brought to the abattoir for slaughter. The goats are from different parts of Uganda, with the majority coming from central and western Uganda. They will be offering a representative population to study the prevalence and incidence of paratuberculosis. The target population will be all the slaughtered goats at the abattoir during the study period. Self sponsored Agricultural Sciences Clinical Trial Degree Award
Martin Origa Jobson Ariel
ID: UNCST-2022-R010809
Validation of cervical cancer screening methods in Uganda: The National Cancer Management and Capacity building Project in Uganda (CANCAP UG) experience.
REFNo: HS6635ES

To assess multiple screening methods: VIA, PAP smear, HPV, and colposcopy, plus or minus biopsy.,To evaluate the indicators of screening accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of Visual Inspection with Acetic acid (VIA) test by comparing with the gold standard of disease status confirmed via histological results.,
Mbarara, cities
Mbarara, cities
Kampala, mulago
Kampala, kisenyi
Uganda 2025-11-21 14:33:45 2028-11-21 4000 All women, 25 years old meeting the inclusion criteria and attending the screening clinic at CANCAP sites uganda cancer insitute Medical and Health Sciences Clinical Trial Non-degree Award
Jackson Mukonzo
ID: UNCST-2021-R013916
Safety of COVIDEX™ Therapy in adults: in Uganda: A randomized controlled open- label phase 1 clinical trial.
REFNo: HS6540ES

Overall aim
To validate the safety of COVIDEX™ therapy in adult Ugandans.

Specific objectives
Primary objective
To evaluate and document adverse events associated with COVIDEX™ among adults
in Uganda.

Secondary objective:
To determine the plasma concentration of berberine in adults receiving COVIDEX™ at
three different dose levels.
Kampala,
Uganda 2025-11-21 14:11:01 2028-11-21 72 Study participants shall be healthy adult volunteers of 18years and above JENA HERBALS LIMITED Medical and Health Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women
REFNo: HS6565ES

To evaluate the efficacy of MK-8527 qm compared to FTC/TDF qd for the prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections To evaluate the safety and tolerability of MK-8527 qm compared to FTC/TDF qd.
Masaka, Masaka
Uganda 2025-11-21 11:18:30 2028-11-21 150 This study includes participants of varying age, race, ethnicity, and sex, female at birth, Aged from 16 years to 30 years of age inclusive, at the time of providing the informed consent or assent and Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during screening. Merck Sharp & Dohme LLC Medical and Health Sciences Clinical Trial Non-degree Award
ERIC WOBUDEYA
ID: UNCST-2019-R001047
Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined with Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age with and without HIV
REFNo: HS6555ES

Primary Objectives
Cohort 1 and Cohort 2
• To determine the weight-band dosing of RPT taken as part of the 1HP regimen by evaluating:
⎯ PK RPT exposures among children with and without HIV
⎯ Safety and tolerability of the 1HP regimen among children with HIV while receiving twice-daily DTG and children without HIV through 28 days of dosing
Cohort 2
• To evaluate the effect of RPT taken as part of the 1HP regimen on the PK of DTG
Secondary Objectives
Cohort 1 and Cohort 2
• To evaluate the effect of covariates including age, weight, sex, ethnicity, nutritional status, and HIV-1 status on the PK of RPT taken as part of the 1HP regimen
• To evaluate the safety of the 1HP regimen through 24 weeks of follow-up
• To evaluate the palatability and acceptability of the 1HP regimen
• To evaluate adherence to the 1HP regimen
Cohort 2
• To evaluate the safety and tolerability of twice-daily DTG through 42 days among children with HIV who are receiving 1HP
• To evaluate virologic control (less than 200 copies/mL) at Day 42 among children taking a DTG-based ARV treatment regimen co-administered with 1HP

Kampala, mulago
Uganda 2025-11-04 12:59:17 2028-11-04 40 children living without HIV (Cohort 1) and children living with HIV (Cohort 2) at risk of TB disease who are less than 13 years of age. National Institute of Allergy and Infectious Diseases Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute of Mental Health Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
A5402 An Open-Label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV
REFNo: HS6604ES

1.2 Primary Objectives

1.2.1 To compare pramipexole to escitalopram in the treatment of MDD (and comorbid MDD with MND) based on the Beck Depression Inventory-II (BDI-II/BDI-2) total score [Beck 1996] from baseline to week 24.

1.2.2 To evaluate the safety of pramipexole and escitalopram in PWH having MDD (and comorbid MDD with MND) from baseline to week 24.

1.3 Secondary Objectives

1.3.1 To compare pramipexole to escitalopram in the treatment of MDD using MDD caseness, neurocognitive outcomes, and functional status from baseline to week 24.

1.3.2 To compare the depression, neurocognitive, and functional status outcomes in PWH with MDD alone and with comorbid MDD with MND treated with pramipexole versus escitalopram from baseline to week 24.

1.3.3 To compare the impact of pramipexole and escitalopram on all outcomes above by female versus male sex (assigned at birth) from baseline to week 24.

1.3.4 To determine the impact of pramipexole compared to escitalopram on the measure of HIV-1 RNA viral load in the peripheral blood.

1.4 Exploratory Objectives

1.4.1 To characterize associations between escitalopram trough concentrations and treatment efficacy (BDI-II/BDI-2 total score) as well as participant adverse events (adverse event frequency, severity, and discontinuation rates).

1.4.2 To characterize associations between escitalopram trough concentrations and genetic polymorphisms that affect metabolizing enzymes of escitalopram (known metabolizing enzymes include CYP2C19, CYP2D6, and CYP3A4).

1.4.3 To explore associations between cerebrospinal fluid (CSF) concentrations of escitalopram and BDI-II/BDI-2 total score.

1.4.4 To evaluate adverse events potentially related to drug interactions between antiretroviral therapy (ART) and escitalopram and pramipexole, respectively.

1.5 Substudy Objective

1.5.1 CSF Substudy

To compare the impact of pramipexole and escitalopram on biomarker outcomes in a CSF substudy of participants with MDD alone.

Uganda 2025-10-29 16:04:25 2028-10-29 50 PWH having a diagnosis of MDD alone or with comorbid MDD and MND · ≥18 to ≤70 years old both male and female. People who understand English and Luganda because the site informed consent forms only in Luganda and English National Institute of Allergy and Infectious Diseases and CIPLA Medical and Health Sciences Clinical Trial Non-degree Award
Abel  Kakuru
ID: UNCST-2022-R009193
Dihydroartemisinin-piperaquine plus sulfadoxine-pyrimethamine versus sulfadoxine-pyrimethamine alone for the prevention of febrile illnesses in children with sickle cell anemia: a double-blind randomized controlled trial
REFNo: HS6294ES

1.
To compare the incidence of all-cause febrile illness among children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
2.
To compare the incidence of adverse events among children with sickle cell anemia randomised to receive monthly SP vs. monthly DP+SP.
3.
To compare the prevalence of markers of antimalarial resistance, including those associated with SP and DP resistance, among parasitemic children with sickle cell anemia randomized to receive monthly SP vs. monthly DP+SP.
Busia, Selected parishes
Uganda 2025-10-29 15:55:44 2028-10-29 232 children with sickle cell anemia Aged 2-10 years children with sickle cell anemia Thrasher Research Fund Medical and Health Sciences Clinical Trial Non-degree Award
Kyambadde Ronald
ID: UNCST-2025-R016678
HIGH DOSE VS STANDARD DOSE CAFFEINE THERAPY FOR APNEA OF PREMATURITY: A RANDOMISED CONTROL TRIAL.
REFNo: HS5776ES

To compare the efficacy and safety of high-dose caffeine citrate (loading dose 40 mg/kg/day, and maintenance of 20mg/kg/day), versus standard dose (loading dose of 20 mg/kg/day, maintenance of 10mg/kg/day), in preventing the occurrence and reducing the frequency of apneas among preterm infants ≤ 34 weeks’ gestation with Apnea Of Prematurity in the first 7 days of life.


Specific Objectives

1. To determine the effect of high dose compared to standard dose of caffeine on the incidence of apnea of prematurity among preterm babies at St. Francis Hospital, Nsambya, and Uganda
Martyrs’ Hospital Lubaga.

2. To determine the side effects of high dose compared to standard dose caffeine in preterm infants.
Kampala, Nsambya
Kampala, Lubaga
Uganda 2025-10-21 9:08:50 2028-10-21 122 participants preterm babies born at the study sites during the study period with a New Ballard score ≤ 34 weeks no sponsorship Medical and Health Sciences Clinical Trial Degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women
REFNo: HS6666ES

To evaluate the efficacy of MK-8527 qm
compared to FTC/TDF qd for the
prevention of HIV-1 infection as assessed
by the incidence rate per year of adjudicated
HIV-1 infections.
Hypothesis: MK-8527 qm is superior to
FTC/TDF qd with respect to the hazard
ratio for HIV-1 infecti
Mityana,
Kalangala,
Kampala,
Masaka,
Wakiso,
Uganda 2025-10-16 17:51:09 2028-10-16 Approximately 4580 participants 16 to 30 years of age Merck Sharp & Dohme LLC Medical and Health Sciences Clinical Trial Non-degree Award
Helen Byakwaga
ID: UNCST-2019-R001168
A Phase III/IV factorial randomised double-blind trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin/ezetimibe versus pitavastatin, in patients with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk (Optimising metabolic management on integrase-based antiretroviral therapy – the OPTIMAR Study)
REFNo: HS5819ES

To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on: fasting lipids, cardiovascular disease risk assessment measures; inflammatory biomarkers; and safety and tolerability,To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on: intermediate markers of cardiovascular disease risk; cardiovascular disease risk assessment measures; clinical consequences of increased body weight; and safety and tolerability of dapagliflozin,To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on LDL concentration change from baseline to week 24,To assess the impact of dapagliflozin vs. placebo on absolute weight change from baseline to week 24,The overall objective of the study is to examine the impact of dapagliflozin vs. placebo on metabolic parameters in PWH with high metabolic risk who are on INSTI-based ART.,
Kampala, Mulago I
Uganda 2025-09-30 14:11:23 2028-09-30 30 at the Infectious Diseases Institute Kampala All adults aged 40-75 years, both female, all tribes will be included. The Kirby Institute Medical and Health Sciences Clinical Trial Non-degree Award
Joweria Nambooze
ID: UNCST-2019-R001118
Effect of consumption of cape gooseberries on blood glucose control among patients with type 2 diabetes mellitus in Kampala, Uganda
REFNo: HS6017ES

To evaluate patient adherence to dietary interventions involving gooseberries,To compare change in glycated hemoglobin (HbA1c) levels among T2DM patients consuming gooseberries regularly as part of their diet with those following a regular diet. ,To assess the effect of regular consumption of gooseberries on fasting blood glucose levels in T2DM patients.,To evaluate the effect of cape gooseberries on blood glucose control among patients with T2DM in Kampala, Uganda.,
Kampala, All parishes
Uganda 2025-09-26 18:13:11 2028-09-26 200 The study will include adult patients with T2DM who attend the Saint (St) Francis Nsambya hospital diabetes clinic and the Mulago hospital diabetes clinic in Kampala. Convenience sampling will be used to select patients from these clinics who meet specific study criteria and are readily accessible. The two study sites will be purposively selected due to having established T2DM clinics, high patient volume, diverse population and proper patient records. However, the study participants will be randomly allocated to the study arms. Kyambogo University Medical and Health Sciences Clinical Trial Non-degree Award
Patrick Okema
ID: UNCST-2025-R019099
Insulin storage in low resource settings, impact on the glycated hemoglobin.
REFNo: HS6078ES

To determine the modalities of insulin storage in children and adolescents with T1D in low resource settings and the effects on their Hemoglobin A1C (HbA1C) in northern Uganda
Gulu, All parish
Amuru, All parish
Nwoya, All parish
Omoro, All parish
Uganda 2025-09-26 18:07:55 2028-09-26 60 - 100 Children and young adolescent with Type1 diabetes registered and is receiving care at the Gulu Regional Referral Hospital under the age of 23 years Sonia Nabeta Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Jef VanPuyenbroeck
ID: UNCST-2025-R017911
Monitoring anthelmintic resistance in goats in Nwoya District, Uganda
REFNo: A617ES

Main objective:
To assess the efficacy of anthelmintics commonly used by goat farmers in Nwoya district.
Specific Objectives:
1. To determine the prevalence of GIN infesting goats in Nwoya district.
2. To determine nematode species infesting goats in Nwoya district, through coproculture and molecular speciation.
3. To compare the expenses to perform routine FECRT, with McMaster and Mini-FLOTAC, for monitoring anthelmintic resistance in Uganda.
4. To assess the efficiency of survey designs and fecal egg count methods to determine drug efficacy at a certain cost and endemicity.
Nwoya, All
Nwoya, All
Nwoya, All
Belgium 2025-09-26 18:06:25 2028-09-26 383 All goat herds, kept for livelihood purposes, in Nwoya District will be considered to be included in this study. Ghent University Agricultural Sciences Clinical Trial Degree Award
Adoke Yeka
ID: UNCST-2021-R004300
An open-label, randomised, controlled, non-inferiority trial to compare the efficacy, safety and tolerability of a fixed dose Triple Artemisinin-based Combination Therapy (TACT) artemether-lumefantrine-amodiaquine versus first-line Artemisinin-based Combination Therapies (ACTs) for the treatment of uncomplicated Plasmodium falciparum malaria
REFNo: HS6344ES

To compare the efficacy of ALAQ vs AL and ALAQ vs ASAQ as defined by the 28-day PCR corrected adequate clinical and parasitological response (ACPR).
Tororo, Selected parishes
Busia, Selected parishes
Uganda 2025-09-26 17:41:17 2028-09-26 1680 Male or female Participants with acute uncomplicated P. falciparum malaria University of Oxford Medical and Health Sciences Clinical Trial Non-degree Award
Robert Ssekitoleko
ID: UNCST-2019-R001716
A Feasibility and Safety Study of the KeySuite Laparoscopic Devices for Cancer Diagnosis in Uganda
REFNo: SIR493ES

1. To evaluate potential safety issues associated with the use of the KeyScope in patients with intra-abdominal cancers or suspected cancers .
2. To determine the clinical performance of the KeyScope in viewing tissue masses in the abdomen.
3. To determine the clinical performance of the KeyLoop in retraction of the abdominal wall during laparoscopic surgery
4. To determine the acceptability of KeySuite laparoscopic devices in aiding to obtain laparoscopic biopsies

Kampala, Mulago II
Uganda 2025-09-26 17:12:49 2028-09-26 12 The study is targeting 12 adult patients with cancer advised for an intra-abdominal biopsy to be collected for confirmatory. The study will target patients aged between 18 and 60 years. National Institute of Health Engineering and Technology Clinical Trial Non-degree Award
Catriona  Waitt John
ID: UNCST-2019-R001068
Drug Optimisation for LMICs in Pregnant HIV mothers and their INfants: temporary switch to CAB/RPV long acting injections in postpartum period
REFNo: HS5982ES

To characterise drug exposure in breast milk, and drug transfer to infants through breastfeeding, as well as infant drug elimination. To characterise the elimination of CAB/RPV by describing PK profiles of IM CAB/RPV LA after last injection between 48 and 96 weeks. To establish strategies on how to safely re-establish oral ART after discontinuation of IM CAB/RPV LA at 48 weeks and switch back to daily oral ART. To explore early postpartum PK of CAB/RPV in maternal plasma and breastmilk. To demonstrate antiviral activity and impact on retention in HIV care of temporarily switching to CAB/RPV LA compared with continuation of daily oral ART over 48 weeks.,
Kampala, Kampala
UK 2025-09-17 13:21:16 2028-09-17 309 Consenting pregnant women living with HIV University of CapeTown 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
Pauline Amuge Mary
ID: UNCST-2023-R005532
LC-REVITALIZE – A Long Covid Repurposed Drug Study
REFNo: HS6370ES

-To assess the efficacy of repurposed drugs compared to their
respective placebos in reducing standardized symptom severity scores
in participants with Long Covid.
-To compare the symptom burden (e.g., anxiety, depression, overall
well-being) in participants with Long Covid treated with repurposed
drugs versus their respective placebos.
- To assess whether symptom burden worsens in participants with Long
Covid treated with study drugs versus placebo, specifically when
symptoms are reported across multiple scales.
- To assess changes in exercise capacity over time of participants with
Long Covid treated with study drugs versus their respective placebos.
- To measure specific Long Covid pathophysiological biomarkers of study
drugs versus their respective placebos.

Wakiso, Sabagabo
Uganda 2025-09-12 17:00:13 2028-09-12 384 Adults, male and female with Long COVID Dr. Douglas D. Fraser- Western University Medical and Health Sciences Clinical Trial Non-degree Award
alice namatovu
ID: UNCST-2025-R017415
EVALUATION OF THE EFFECTIVENESS OF BACTERIOPHAGE COCKTAILS AGAINST MULTI-DRUG-RESISTANT BACTERIA ON PATIENTS WITH DIABETIC FOOT ULCERS ATTENDING SELECTED REFERRAL HOSPITALS IN UGANDA
REFNo: HS5652ES

Main objective:
To assess the efficacy of bacteriophages in the management of diabetic foot wounds/ulcers in animal models and among patients attending the selected referral hospitals in Uganda.

Specific Objectives
i) To determine the biological and genotypic characteristics of lytic bacteriophages against the MDR- bacteria isolated from diabetic wounds of patients.

ii) To determine the virulence genes of the bacteria isolated from DFU patients and those genes associated with antimicrobial resistance.
iii) Determine the phage receptor genes on the MDR bacteria isolated from DFU patients.

iv). To evaluate the effectiveness of the identified Bacteriophage preparation/cocktail in the healing of induced diabetic wounds in mice.
v). To evaluate the effectiveness of the identified bacteriophage preparation/cocktail in the healing of diabetic foot wounds on patients in selected referral hospitals in Uganda.

Kampala, Namirembe
Kampala, Nsambya
Uganda 2025-09-12 16:14:57 2028-09-12 138 human participants The study will be conducted on patients attending the selected regional referral hospitals in Uganda diagnosed with diabetes including those having diabetic foot ulcer/wounds that are not responding to antibiotic therapy, those with diabetes and not having diabetic foot and those without diabetes but having chronic wounds. Inclusion and exclusion criteria: All Patients of 18 years and above, male or female diagnosed with diabetes and willing to participate in the study will be included. Diabetic type will be determined clinically based on the diabetes control strategy used. Those depending on insulin for diabetes control since the time of diagnosis will be classified as having T1DM while those who had been controlled on oral anti-diabetic drugs with or without insulin will be categories as T2DM. One hundred and thirty-eight patients expected to participate in the study as cases are expected to have non traumatic DFU while the control group will include diabetic patients without DFU and non-diabetic patients with chronic foot wounds. The different groups will be matched for age and gender. The exclusion criteria will include pregnant women, patients with other diabetes other than types 1 and 2, and those with wounds limited to above the ankle joints. Makerere Research and innovation Fund by the Ugandan Government Medical and Health Sciences Clinical Trial Non-degree Award
Nazarius Tumwesigye Mbona
ID: UNCST-2019-R000664
WEB-BASED INTERVENTION FOR ALCOHOL AND SUBSTANCE ABUSE AMONG YOUNG UNIVERSITY STUDENTS
REFNo: SS1785ES

To assess feasibility and effectiveness of the web-based intervention for prevention and treatment of ASUD problems among youth 18-24 years attending Universities in Uganda,To develop a web-based intervention for prevention and treatment of ASUD problems among youth 18-24years attending Universities in Uganda,To establish the prevalence of ASUD problems among youth 18-24years in selected Universities,To contribute to the improvement of the quality of ASUD treatment services in Uganda among the youth through the development of a web-based intervention and assess its feasibility and effectiveness for the prevention and treatment of ASUD among University students in Uganda,
Kampala, Mulago
Mpigi, Nkozi
Uganda 2025-09-09 8:17:25 2028-09-09 5000 Any student aged 18 – 24 years at any level of education from the following universities: Makerere University, Kyambogo University, Makerere University Business School (semi-independent public entity), Uganda Christian University, Uganda Martyrs University Nkozi, Kampala International University (KIU) and Ndejje University. Government of Uganda Social Science and Humanities Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
Randomised controlled trial to assess the efficacy of artemisinin combination therapies in a setting of emerging artemisinin resistance in Uganda.
REFNo: HS6327ES

To assess the 42-day clinical and parasitological efficacy of artemether-lumefantrine (AL) and pyronaridine-artesunate (PA) for the treatment of uncomplicated P. falciparum malaria in Uganda.
Arua, Selected parishes
Tororo, Selected parishes
Uganda 2025-09-09 16:41:47 2028-09-09 150 patients on each treatment arm per site, 600 participants in total, (300 per site, AL: 150, PA: 150). Febrile patients aged 6 months to 10 years with confirmed uncomplicated P. falciparum malaria. Infectious Diseases Research Collaboration (IDRC) Medical and Health Sciences Clinical Trial Non-degree Award
Fred  Bulamba
ID: UNCST-2020-R014888
PErioperative respiratory care and outcomes for patieNts Undergoing hIgh risk abdomiNal surgery
REFNo: HS2178ES

To explore the cost-effectiveness of the different treatment combinations in reducing pneumonia and SSI at pre-selected centres.,To assess the impact of both interventions on postoperative mortality at 30-days, and the effect of 80-100% FiO2 only on the re-operation rate at 30 days after surgery.,To assess whether (1) preoperative 0.2% chlorhexidine mouthwash reduces the rate of postoperative pneumonia at 30-days compared to no mouthwash, and (2) 80-100% FiO2 used during surgery reduces the rate of postoperative SSI at 30-days compared to 21-35% FiO2, amongst patients aged 10 years or over undergoing elective or emergency midline laparotomy, with an anticipated abdominal incision of ≥5cm, for any indication except caesarean section.,
Mbale, Hospital cell
Uganda 2025-08-28 10:15:49 2028-08-28 1000 (for Uganda only) Patients above 10 years undergoing abdominal surgery Dr Birgit Whitman Medical and Health Sciences Clinical Trial Non-degree Award
Edwin Nuwagira
ID: UNCST-2021-R013488
EFFICACY AND TOLERABILITY OF SHORT-COURSE INTERMITTENT INTRAVENOUS LIPOSOMAL AMPHOTERICIN B VERSUS ORAL POSACONAZOLE FOR CHRONIC PULMONARY ASPERGILLOSIS: A PHASE IIA, PROSPECTIVE, MULTI-CENTRE, RANDOMIZED, CONTROLLED, OPEN-LABEL, FEASIBILITY TRIAL
REFNo: HS6400ES

5. Assess recruitment and retention of patients with CPA on a trial to inform design and sample size for a definitive efficacy trial.,4. To assess adherence to posaconazole therapy,3. To evaluate the utility of different trial endpoints (change in Aspergillus IgG antibody titer, radiological improvement, step test and weight) across groups.,2. To compare 12-month all-cause mortality in each arm,1. To measure emergence of isolates of Aspergillus with resistance/reduced susceptibility to posaconazole in both arms. ,1. Compare the efficacy and tolerability of 1) short course, high dose of intravenous liposomal amphotericin B, 2) short course, high dose of intravenous liposomal amphotericin B followed by daily posaconazole, or 3) posaconazole alone for the treatment of CPA for 6 months.,
Mbarara, Medical cell
Gulu, Medical cell
Kampala, Salama road
Uganda 2025-08-26 13:48:03 2028-08-26 120 Adults, age > or = to 18 years All Ugandan tribes living in Ankole/Kigezi sub region Both women and men Fungal Infection Trust Medical and Health Sciences Clinical Trial Non-degree Award
RACHEL LUWAGA
ID: UNCST-2024-R003040
EFFECT OF A DISCHARGE EDUCATION INTERVENTION ON PREVENTION OF PUERPERAL SEPSIS AMONG MOTHERS WHO HAVE DELIVERED BY CESAREAN SECTION IN SOUTHWESTERN UGANDA
REFNo: HS5504ES

. To determine the prevalence, factors, and outcomes associated with readmission of
mothers who had undergone cesarean section delivery due to sepsis in Mbarara Regional
Referral Hospital
2. To describe the experiences and practices of mothers in the prevention of puerperal sepsis
post cesarean section in Mbarara Regional Referral Hospital
3. To explore the barriers and facilitators to the provision of discharge instructions
regarding puerperal sepsis prevention for mothers who have delivered by cesarean
section in Mbarara Regional Referral Hospital
4. To determine the effect of a discharge education intervention in the prevention of puerperal of
sepsis in post-cesarean section mothers.

Mbarara, Kamukuzi
Uganda 2025-08-18 13:28:40 2028-08-18 8-10 mother with peurperal sepsis,8-10 health workers, 130 pr mothers diagnosed with puerperal sepsis after cesarean section delivery Health workers working on the obstetric and gynecology ward Primipara mothers who have delivered by cesarean section self sponsorship Medical and Health Sciences Clinical Trial Degree Award
Claire Nimusiima
ID: UNCST-2025-R017994
Assessing the association Between Disability and Mental Health among older adults: A Secondary Data Analysis of the Health and Wellbeing of Older People - Wave 5 study in Uganda.
REFNo: HS6244ES

Primary Objective
To assess the association between disability and mental health outcomes among older adults in Uganda.

Secondary Objectives
- To determine the prevalence of mental health disorders among older adults with and without disabilities.
- To explore whether any socio-demographic factors modify the association between disability and mental health outcomes.
- To assess whether HIV status confounds the association between disability and mental health outcomes.

Not Applicable (N/A), Not Applicable
Uganda 2025-08-08 13:49:11 2028-08-08 588 The WOPS V study population consists of older adults (aged 50 years and above), including both HIV-positive individuals on ART and HIV-negative individuals. In Wave 5, 588 participants were surveyed. The WOPS study was conducted in 3 districts in Uganda: Masaka, Kalungu, and Wakiso. Participants are recruited from rural, peri-urban, and urban settings, including community health centers and HIV care clinics. The study was coordinated by the MRC/UVRI & LSHTM Uganda Research Unit. It is this study population that shall be included in the "Assessing the association Between Disability and Mental Health among older adults: A Secondary Data Analysis of the Health and Wellbeing of Older People - Wave 5 study in Uganda" study No funding is available for this proposed research as this is going to use already existing dataset. However, the WOPSV study was sponsored by National Institutes of Ageing, USA, through World Health Organization Study on Global Ageing and Adult Health (SAGE) Medical and Health Sciences Clinical Trial Degree Award
David Meya Bisagaya
ID: UNCST-2019-R000837
A Phase 2 Novel Antimicrobial Combination Therapy to Treat Tuberculous Meningitis
REFNo: HS5711ES

1. Assess the safety and efficacy of a novel anti-TB combination regimen with greater bactericidal activity than current standard of care (SOC) therapy
Kampala, all parishes
Mbarara, all parishes
Uganda 2025-07-18 14:05:06 2028-07-18 150 All adults with TBM meningitis (definite, probable) with HIV, per the uniform TBM case definition. Meningitis Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Felix Magala
ID: UNCST-2024-R016043
Incidence of Post-Operative Sore Throat Among Patients Undergoing Open Abdominal Surgery: A Randomized Control Trial Comparing Video and Direct Laryngoscopy
REFNo: HS5685ES

To compare the incidence of POST, and recovery from POST following intubation using Video laryngoscopy or Direct laryngoscopy during general anaesthesia among general surgery patients undergoing laparotomy at MRRH
1. To determine the incidence of POST in the first 24 hours following intubation with either Video-laryngoscopy or Direct-laryngoscopy for patients undergoing open abdominal surgery at MRRH
2. To determine the recovery time from POST among patients intubated with Video laryngoscopy compared to Direct-laryngoscopy.
3. To describe the symptoms associated with POST amongst patients intubated for open abdominal surgery
Mbarara, Mbarara
Uganda 2025-07-11 18:00:56 2028-07-11 148 Study population We will recruit surgical patients scheduled for laparotomy (open abdominal surgery, requiring an incision of at least 5cm) at the surgical and emergency ward of MRRH. Eligibility criteria We shall include; • General surgery patients scheduled for laparotomy under general anaesthesia. • Aged 18 years and above. • ASA class I to III. • Mallampati class I to II. We shall exclude: • Have had an upper respiratory tract infection or have had an endoscopy or bronchoscopy procedure in the past 2 weeks. • Have had any ENT, neck or thoracic surgery in past 3 months. • Those who have symptoms of gastroesophageal reflux disease (GERD). • And those with history of smoking. • Those with anatomical abnormality in the neck, head, face. • Edentulous patient. • Patients with suspected difficult airway as assessed by the principal investigator. self sponsored Medical and Health Sciences Clinical Trial Degree Award
Daniel Atwine
ID: UNCST-2019-R012948
SAFETY AND EFFICACY OF THE PHOTO-KABADA DEVICE AS COMPARED TO DEVICES IN ROUTINE USE IN ADMINISTERING PHOTOTHERAPY FOR BABIES WITH NEONATAL JAUNDICE: AN OPEN-LABEL, RANDOMIZED CONTROLLED CLINICAL TRIAL (MUST-2024-1404).
REFNo: HS5411ES

5) Secondary: To describe the experiences of health workers using the test (Photo-Kabada) and control PT devices and caretakers of children treated with these devices.,4) Secondary: To compare the other safety and efficacy outcomes when babies are treated with Photo-Kabada compared to available phototherapy devices on the neonatal unit of MRRH. ,3) Secondary: To compare the reduction in bilirubin levels per unit time when babies are treated with Photo-Kabada compared to available phototherapy devices on the neonatal unit of MRRH. ,2) Primary: To compare the efficacy of Photo-Kabada phototherapy machine with existing phototherapy machine at selected hospitals in treating neonates with jaundice.,1) Primary: To compare the safety of Photo-Kabada phototherapy machine with existing phototherapy machine at selected hospitals in treating neonates with jaundice.,
Mbarara, Nyamitanga
Uganda 2025-07-10 11:09:52 2028-07-10 30 neonates less than 28 days old. Both male and female. Villgro Africa Medical and Health Sciences Clinical Trial Non-degree Award
Esther Cathlyn  Atukunda
ID: UNCST-2022-R009265
Evaluating Healthy Families PrEP: an intervention to promote PrEP use during periconception, pregnancy and postpartum periods for women in rural Uganda
REFNo: HS6117ES

1. Adapt Healthy Families-PrEP (HF-PrEP) to community clinics in Mbarara and Sheema Districts, Uganda to include postpartum women guided by our conceptual framework and the Consolidated Framework for Implementation Research (CFIR

2. Test Healthy Families-PrEP intervention effectiveness in a cluster-randomized control trial in Ugandan community health centers (HCs)

3. Determine incremental cost-per-person participating in Healthy Families-PrEP and estimate cost-effectiveness per incident HIV infection averted among women and their infants.
Mbarara, All parishes
Sheema, All parishes
Uganda 2025-07-09 16:14:46 2028-07-09 approximately 700 women There will be two groups of participants engaged for these studies: 1) women ages 18-45 years, in periconception, pregnant, and postpartum periods seeking health services from the community health centers 2) healthcare providers, administrators, and Ministry of Health officials National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Laura Nsangi Joan
ID: UNCST-2025-R016715
ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse
REFNo: HS6040ES

The primary objective is to determine if valganciclovir is safe and efficacious in reducing CMV viraemia amongst hospitalised adults with advanced HIV disease and CMV viraemia.
Secondary objectives are to determine the effect of valganciclovir on mortality, to study its pharmacokinetics and explore the immunological response of patients with CMV viraemia before and after treatment with valganciclovir.

Kampala, Mulago
Uganda 2025-07-04 14:08:02 2028-07-04 150 Adults and adolescents (≥ 15 years) diagnosed with advanced HIV disease and CMV viraemia, with a CD4 count ≤ 100 cells/μL and CMV viral load >500 IU/mL. Wits Health Consortium Medical and Health Sciences Clinical Trial Non-degree Award
Sam Ononge
ID: UNCST-2020-R000328
A CLINICAL TRIAL TO EVALUATE THE PERFORMANCE AND SAFETY OFTHE WEKEBERE SYSTEM FOR MONITORING FETAL WELLBEING DURING LABOUR
REFNo: HS3407ES

The overall objective of this study is to demonstrate safety and performance of wekebere fetal monitoring system.

Specific Objectives
To determine accuracy of wekebere fetal monitoring in comparison with gold standard. To determine the safety of wekebere system
To determine’ uterine contractions

Kampala, Kawempe
Uganda 2025-06-30 9:35:11 2028-06-30 120 The study population will consist of the following inclusion criteria: i.Female age between: 18-50 ii.Gestational age >36 + 0 weeks iii.Singleton pregnancy iv.Early labor (cervical dilatation of <6cm) v.Sign informed consent Villgro Africa Medical and Health Sciences Clinical Trial Non-degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
OPTIMAH Study: OPTImizing Malaria And HIV treatment in a shifting landscape in Africa
REFNo: HS6165ES

PRIMARY OBJECTIVES
1. Assess the impact of HIV/DTG on weight gain (BMI) in Ugandan children ages 5 to 17 years of age over two years of follow-up.
2. Assess for PK drug-drug interactions between the two most widely used ACTs
(AL or AS-AQ) and DTG in longitudinal cohorts of HIV-uninfected children and CLHIV living in a high endemic malaria region (Busia).
3. To assess the 28- and 42-day efficacy of AL and AS-AQ for the treatment of uncomplicated malaria in children with and without HIV in a setting where artemisinin resistance has emerged.

SECONDARY OBJECTIVES
1. To assess the impacts of DTG on changes in body composition, waist circumference, and metabolic derangements over 2-years of longitudinal follow-up.
2. To assess the impact of repeated malaria infection on changes in weight gain in CLHIV on DTG (comparing HIV-infected cohorts in Busia and Kampala).
3. To determine if changes in DTG PK exposure in the presence of repeated courses of ACTs are associated with impacts on virologic control (pharmacodynamics).
4. To assess for the development of dolutegravir-associated resistance mutations over two years of follow-up.
5. To determine if changes in ACT exposure in the presence of daily DTG for HIV treatment are associated with impacts on malaria treatment outcomes.
6. To critically compare the PK exposure of artemether, artesunate, and DHA in the context of the two leading ACTs in Africa and assess for associations between the PK exposure of artemisinin derivatives as drivers of parasitologic outcomes such as parasite clearance rates for artemisinin-sensitive and resistant infections.
7. To assess levels of gametocytemia in children with and without HIV infection and with artemisinin-sensitive and -resistant infections
8. To determine if repeated course of AL and AS-AQ are associated with selection of resistance-associated mutations to the partner drugs and/or the artemisinin component.
9. To identify novel mutations in known and/or putative loci associated with resistance to artemisinins, lumefantrine, and amodiaquine using amplicon-based sequencing and/or other genotyping methods.
10. To assess the exposure of unbound DTG, lumefantrine, and DEAQ and association with clinical outcomes (viral load or parasitemia)



Busia, All Parishes
Kampala, Mulago
Uganda 2025-06-26 23:59:42 2028-06-26 380 CLHIV, ages 5-17 years, will be identified from respective registers at Baylor-Uganda (in Kampala) and the Masafu HIV clinic (and nearby clinics) in Busia Uganda. HIV-uninfected children, also ages 5-17 years, will be enrolled from catchment areas at these two sites. Recruitment will be balanced by age and sex. The National Institute of Child Health and Human Development Medical and Health Sciences Clinical Trial Non-degree Award
Jolly  Kamugisha G.K.
ID: UNCST-2023-R005715
Performance and Factors Affecting the Implementation of the Integrated Management of Acute Malnutrition Programme: A Study of Kampala, Mukono, Wakiso and Kayunga Districts
REFNo: HS6084ES

5. To document the lessons learnt and best practices during implementation of the IMAM program in the four target districts during the calendar year 2022 and 2023.,4. To establish factors that affect the utilization of IMAM services in the four target districts.,3. To determine factors influencing treatment outcomes of children with wasting in the four target districts.,2. To determine the performances of the integrated management of acute malnutrition program in the four target districts during the calendar year 2022 and 2023.,1. To identify the communities contributing to a high burden of childhood wasting caseload in health facilities in four target districts (Kampala, Mukono, Wakiso and Kayunga),The overall objective of this study is to assess the nutrition service delivery and factors influencing utilization of the IMAM programme in Kampala, Mukono, Wakiso and Kayunga districts,
Kampala,
Mukono,
Wakiso,
Kayunga,
Uganda 2025-06-20 8:41:29 2028-06-20 Sample size varies by objective as follows: Objective 1: 1440 records; Objectives 3-5: 5 key informants ()KIIs) at policy level; 8 KIIs - district and facility administrators; 7 KIIs for health workers at facility level. 1) Children aged < 5years with acute malnutrition - both boys and girls (Records review) 2) Caregivers of children treated acute malnutrition (both females and males aged 18+years) 3) Village Health Teams (both males and females adults aged 18+ years) 4) Health workers caring for children with acute malnutrition (Male and females aged 18+ years; District and health facility administrators (male and female aged 18years 5) Policy level stakeholders, both male and female aged 18+ years) UNICEF Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
REFNo: SS3990ES

Suubi4PrEP will examine the effect of a multilevel intervention, combining HIV risk reduction that incorporates sessions on PrEP, peer supporters with lived experiences to facilitate linkage to and continued care, and economic empowerment components targeting financial barriers associated with PrEP access, PrEP initiation, uptake and adherence among AGYW in Uganda. Study aims are:

Aim 1: Examine the impact of Suubi4PrEP on PrEP initiation (primary outcome); and PrEP adherence (secondary outcome).

Aim 2: Examine the effect of Suubi4PrEP on hypothesized mechanisms of change (financial stability, PrEP stigma, self-efficacy, depressive symptoms, and social support) and intervention mediation.

Aim 3: Use mixed methods to explore multi-level factors that influence PrEP initiation and adherence.

Aim 4: Assess the cost and cost-effectiveness of the interventions.

Masaka, Nyendo
Lwengo, Kinoni
Kyotera, Kakuuto
Kalungu, Bukulula
Rakai, Kakuuto
Sembabule, Sembabule TC
Bukomansimbi, Mbiriizi
Uganda 2025-06-20 7:41:25 2028-06-20 600 The target study population for the proposed Suubi4PrEP study is AGYW (15-24 years) living in HIV hotspots in the greater Masaka region of Uganda. Emancipated minors (below 18 years) will not need parental/caregiver consent. In Uganda, the National Guidelines for Research Involving Humans as Research Participants (NGHRP) define a child as any person below the age of 18. On the other hand, an emancipated minor is defined as an individual below the age of 18 who are pregnant, married, have a child, or are self-sufficient. Inclusion Criteria. Female between 15-24 years. AGYW will be screened for HIV risk as determined by the national risk screening tool developed by the Uganda National AIDS Control Program, in alignment with national PrEP guidelines. AGYW will be deemed to be at substantial risk, and eligible to participate in the study, if they report at least one of the seven high-risk sexual behaviors on the risk assessment tool. Exclusion criteria. A participant will be excluded if they are: 1) HIV Positive, 2) unable to understand the study procedures and/or participant rights during the informed consent process, or 3) they are unwilling or unable to commit to completing the study. If the potential participant has emergency needs (e.g., hospitalization), they will be referred for care instead. Peer Supporters. These will be women who are HIV negative, enrolled and adhering to PrEP. We expect to recruit at least four peer supporters at each of the 20 sites receiving the PS intervention component. National Institute for Mental Health Social Science and Humanities Clinical Trial Non-degree Award
Denis Nansera
ID: UNCST-2024-R004002
Improving HIV testing among Children under five in Rural Uganda
REFNo: HS5829ES

The main objective of this study is to develop a traditional healer facilitated paediatric HIV testing program to improve access to paediatric HIV testing. To do this, we will first use qualitative study methods to determine factors that influence HIV testing among paediatric clients of TH and guide adaptation of the TH-facilitated HIV testing program for children. We will then implement a pilot study to evaluate offering paediatric HIV testing at traditional healer locations in southwestern Uganda.
Uganda 2025-05-29 17:12:49 2028-05-29 465 Aim 1: Key stakeholders for Aim 1 will be defined as 1) adult caretakers of children ≤5 years old who receive care from TH in Mbarara District; 2) TH who care for more than 15 children under five each month; and 3) paediatric HIV clinicians from surrounding Health Centres III and IV. All participants will be 18 years or older, and able to provide informed consent. HIV clinicians must also have been in a patient-facing position (doctor, nurse, social worker, counsellor) for at least one year at the time of enrolment. Aim 2: The study population will be ten TH with monthly volume of 15 children five years old or younger, and 200 children 18 months to 5 years of age who receive care from these TH practices in Mbarara District. Inclusion criteria for TH: aged 18 or older, consent to recruitment of children at their practice, agree with goals of the study and associated procedures, and agree to attend all study-related training. Exclusion criteria will be the same as in Aim 1 above. Inclusion criteria for children are: 18 months to 5 years old; have a parent or caregiver who can provide informed consent; not previously tested for HIV in the past three months; and not previously known to be HIV-infected. National Institute of Mental Health Medical and Health Sciences Clinical Trial Non-degree Award
Nanyonga Elizabeth Monica
ID: UNCST-2025-R018232
srd
REFNo: SIR516ES

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Uganda 2025-05-27 9:30:38 2028-05-27 AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA Engineering and Technology Clinical Trial Non-degree Award
Fred  Bulamba
ID: UNCST-2020-R014888
Rule of THUMB: A multi-centre cluster trial evaluating the implementation of a perioperative care complex intervention to improve outcomes from haemorrhage during and after caesarean section in African hospitals
REFNo: HS5855ES

To evaluate the effect of the trial intervention on patient outcomes relevant to future trials.,To evaluate whether implementation of the ‘Rule of THUMB’ perioperative complex intervention increases risk assessment and improves diagnosis and compliance with proven interventions for haemorrhage during and after caesarean section.,
Mbale, Hospital Cell
Uganda 2025-05-14 9:24:07 2028-05-14 600 Any patient who requires a caesarean section Department of Anaesthesia and Perioperative Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Mohamed Farah Mohamud
ID: UNCST-2025-R016841
EFFECTIVENESS OF INTRAVENOUS PETHIDINE VERSUS INTRAVENOUS TRAMADOL FOR PERIOPERATIVE ANALGESIA IN UTERINE EVACUATION PROCEDURES AT JINJA REGIONAL REFERRAL HOSPITAL
REFNo: HS5960ES

1. To assess the effectiveness of intravenous pethidine versus intravenous tramadol for perioperative analgesia in uterine evacuation procedure at Jinja Regional Referral Hospital
2. To compare the secondary outcomes encountered among women administered with intravenous pethidine versus those with Intravenous Tramadol for perioperative analgesia in uterine evacuation procedures at Jinja Regional Referral Hospital
3. To compare the level of patient satisfaction with intravenous pethidine versus Intravenous tramadol in uterine evacuation procedures at Jinja Regional Referral Hospital

Jinja, rippon
Somalia 2025-04-30 7:27:21 2028-04-30 170 t All adult women with an indication for uterine evacuation admitted on gynecology ward of Jinja Regional Referral Hospital selfsponser Medical and Health Sciences Clinical Trial Degree Award
Flavia Matovu Kiweewa
ID: UNCST-2021-R013337
An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments.
REFNo: HS5804ES

The primary objective of this trial is to provide continued access to the study medication received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) for participants who completed a Gilead parent study evaluating medications for HIV treatment.
Kampala, kampala
Uganda 2025-04-11 16:20:58 2028-04-11 This study is not formally powered. The purpose of this study is to provide continued access to the study medication received in the parent study or to provide B/F/TAF to applicable participants who have completed a relevant parent study. Therefore, all participants who are on parent study medication and have completed a Gilead parent study evaluating medications for HIV treatment may be enrolled in this study dependent on eligibility. Participants who have completed a parent study and meet all eligibility criteria will be offered the opportunity to roll over to this study and receive the same regimen as in the parent study. Participants will also be allowed to switch to B/F/TAF when they enroll in this study if they meet the additional eligibility criteria. Gilead sciences Inc Medical and Health Sciences Clinical Trial Non-degree Award
Janet Nakigudde
ID: UNCST-2019-R000444
TESTING MULTI-LEVEL SCALE-UP STRATEGIES TO IMPLEMENT A SCHOOL-BASED POPULATION APPROACH OF MENTAL HEALTH PREVENTIVE INTERVENTION: UGANDA
REFNo: HS5647ES

General Objective
The overall goal of this study is to address vertical and horizontal scale-up implementation framework gaps in Uganda. This study will test new recommended vertical scale-up and sustainability implementation strategies and study impact and underlying mechanisms when the new scale-up model is applied.
This research will guide the development of evidence-informed theoretical frameworks and processes to effectively institutionalize EBIs in LMICs such as Uganda. To achieve this goal, we will carry out 4 sequential steps (4 aims).
Specific Objectives
1.
To establish a cross-level partnership and strengthen stakeholders/leaders’ advocacy capacity to make evidence-based informed children’s mental health policy and practice decisions and to facilitate the EBI institutionalization through the educations system illustrated in figure 1.
2.
To develop implementation Protocols in collaboration with cross level partners (established in Aim 1) based on a new multilevel train-the-trainer scale-up framework to support the EBI/PD scale-up.
10
3.
Implement the new Protocols for scale-up and test the relative value of additional implementation supports intended to sustain teacher EBI practices through a Hybrid III cRCT.
4.
To explore underlying scale-up and sustainability implementation mechanisms.
Arua, Lodonga, Arua Hill
Mityana, Busubizi, Kyanja
Gomba, Kabulasoke, Nakato
Masaka, Ndegeya, Kyanamukaka
Buikwe, Nkokonjeru, Kasenge
Kabale, Bukinda, Nyaruzinga
Bushenyi, Nyakabirizi
Sheema, Nyabubare
Western Region, Burahya
Iganga, Lwawu
Soroti, Kolojjo
Gulu, Awach
Uganda 2025-04-11 16:03:54 2028-04-11 The study population and sample will consist of approximately 1,594 participants.46 Advocacy Leaders and Education System Leaders, including 10 from the Ministry of Education (MOE)/Ministry of Health (MOH), 12 from Teacher Training Colleges (TTCs), 12 from District Education Offices, and 12 head teachers (one from each school district/region). Additionally, 12 TTCs will be selected based on MOE prioritization and needs, with 96 tutors trained in Evidence-Based Intervention (EBI) implementation (8 per TTC). The study will also include 120 schools that are stratified and randomized, with approximately 1,200 teachers (10-15 per school) and 240 Peer Teacher Trainers (PTTs) selected and trained. The study population will consist of participants from diverse backgrounds. The age group of the participants will vary, with Advocacy Leaders and Education System Leaders typically being adults in their 30s and 40s, while teachers, tutors, and Peer Teacher Trainers (PTTs) will range from 20 to 50 years of age. The study will aim for gender balance, with an equal representation of male and female participants. Participants will be drawn from various ethnic groups across Uganda, including, but not limited to, Baganda, Basoga, Banyankole, Bakiga, and other tribal groups, ensuring inclusivity and representation from all regions of Uganda. The study will also reflect the diversity of the Ugandan educational system, capturing perspectives from urban and rural settings, as well as from different educational leadership and teaching roles. This study is sponsor by the United States National Institute of Mental Health through a collaboration with New York University, Department of Population Health, New York School of Medicine and Makerere University College of Health Sciences, Department of Psychiatry Medical and Health Sciences Clinical Trial Non-degree Award
FRED TWINOMUGISHA
ID: UNCST-2024-R003414
THE ROLE OF INVOLVING PATIENTS IN PROMOTING HAND HYGIENE PRACTICES AMONG HEALTHCARE WORKERS IN MUKONO AND KAGADI DISTRICTS: A MIXED METHODS STUDY
REFNo: HS5449ES

1)To determine the level of knowledge and practice on hand hygiene among patients and health workers in selected healthcare facilities in Mukono and Kagadi districts, Uganda.
2)To explore the barriers and facilitators of involving patients in promoting hand hygiene practices among healthcare workers in selected healthcare facilities in Mukono and Kagadi districts, Uganda.
3)To explore the perceptions of healthcare workers on involving of patients in promoting hand hygiene practices in selected healthcare facilities in Mukono and Kagadi districts, Uganda.
4)To design and evaluate an intervention to improve hand hygiene among health workers.

Mukono, All
Kibaale, All
Uganda 2025-04-11 14:30:15 2028-04-11 OBJECTIVE 1, 1292 This study will be conducted within the two districts of Mukono and Kagadi local governments. Study population: Patients admitted in Medical, Marternal and surgical wards aged 18 years and above. Tribes, all tribes both male and female. PROMISE CONSORTIUM PROJECT IN MAKERERE UNIVERSITY SCHOOL OF PUBLIC HEALTH Medical and Health Sciences Clinical Trial Degree Award
Ouma Simple
ID: UNCST-2021-R012820
Harnessing Parental Social Networks to Increase HIV Testing Uptake Among Children of At-Risk Parents in Uganda: A Parallel-Group, Two-Arm Quasi-Experimental Implementation Science Protocol
REFNo: HS5741ES

Objectives:

Main Objective

To Adapt, implement and evaluate maternal SNS to improve access to HIV testing services among children of FSW.

Specific Objectives

1. To adapt SNS that harnesses maternal SN for HIV testing in children of female sex workers
2. To implement the adapted HASHTAG intervention targeting CARP in Gulu City
3. To evaluate the effectiveness and implementation science outcomes of the HASHTAG project
Gulu, All Parishes
Uganda 2025-04-11 14:13:08 2028-04-11 300 The target group for Intervention: We shall invite FSW with at least one child aged 0-17 years. For mothers to be categorized as FSW, each must have received money or goods in exchange for sexual services and consciously defined their activities as income-generating. In addition, we shall enrol active FSW who have been conducting sex work during the one year before setting up the cohort. Thus, maternal sex work status will be ascertained using three questions as follows: 1) Have you ever received money or goods in exchange for sexual services? 2) If yes, have you received money or goods in exchange for sexual services in the last year? 3) If yes, do you consider your receipt of money or goods for sexual services as income-generating? Mothers who answered "yes" to all three questions will be considered FSW. Conversely, mothers who answer "no" to either questions 2 or 3 will be considered non-FSW and be eligible to participate if they have been living in the same neighbourhood as the FSW in the past year before setting up the cohort (Attachment 1). We shall enrol only FSW who do not plan to move outside the greater Gulu in the one year following recruitment into the cohort. The comparator cohort: The comparative cohort will be matched 1:1 and will comprise non-sex working mothers matched on the neighbourhood, maternal age, child age, and child sex. The comparators must have lived in the same neighbourhood as FSW for at least the year before enrolment. Likewise, we shall enrol only non-FSWs who do not plan to move outside the greater Gulu in the one year following recruitment into the cohort. The children: Much as children of FSW are the direct target of the intervention, we shall not directly involve them as active participants in the cohort. Children of FSW will be randomly selected from both sexes and without stratification. Meanwhile, children of non-FSW will be matched to children on FSW in the neighbourhood, maternal age, child age, and child sex. IPHASA Medical and Health Sciences Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
An open-label randomised controlled trial comparing novel combination and currently used antibiotic regimens for the empiric treatment of neonatal sepsis with a run-in confirmatory pharmacokinetic phase: NeoSep1
REFNo: HS5639ES

In Part 2, a secondary objective is to provide a ranking of clinically relevant antibiotic regimens based on other efficacy and safety secondary outcomes, as well as on health economic measures and the potential selection of resistance. The trial data will provide data to inform the balance between efficacy, safety, costs (and cost-effectiveness and equity, using health economic analysis) and propensity for resistance selection (based on microbiology tests) that will influence facility-level and national decision-making about adoption of studied regimens, and potential future inclusion in WHO guidelines.,In Part 2, the primary objective is to provide a ranking of eight different clinically relevant antibiotic regimens for first-line empiric and second-line (after lack of response/deterioration) treatment in terms of 28-day mortality as the primary outcome measure. It will flexibly compare these multiple different relevant treatment regimens to enable the trial to be run in sites worldwide with very different background rates of different pathogens, of resistance and patterns of routine clinical care by randomising each participant to locally relevant antibiotic regimens agreed prior to site initiation. The trial will ensure generalisability by focusing inclusion based on clinical symptoms associated with high mortality risk in the NeoOBS study, which have been developed into a novel neonatal sepsis severity score – the NeoSep Severity Score.,
Kampala, Kawempe
Kampala, Mulago
Uganda 2025-04-02 9:04:16 2028-04-02 400 for the MU-JHU site.Approximately 3000 participants across all participating sites. Neonates≤28 days of age hospitalised with clinical signs of neonatal sepsis. Global Antibiotic Research & Development Partnership (GARDP) Medical and Health Sciences Clinical Trial Non-degree Award
Sylvia Kusemererwa
ID: UNCST-2019-R001717
A phase III, multi-center, 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: HS5607ES

To assess the efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without
hydroxyurea (HU)/hydroxycarbamide (HC) , on VOC rate in Sickle Cell Disease (SCD) patients aged 12 years and older who experience frequent vaso-occlusive crises (VOCs)
Primary Objective
1. 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 HCP managed (including VOCs leading to management at a health care facility or those 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).
Secondary Objectives
1. 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 screening visit).
2. 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
Page 4 of 18
 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
Masaka, Masaka
Uganda 2025-04-02 8:58:47 2028-04-02 20 A total of 10-20 participants will be recruited at the MRC/UVRI and LSHTM Uganda Research Unit site. Recruitment will be competitive across sites and countries. Participants will be recruited through referrals from the sickle cell clinic at the Masaka Regional Referral Hospital. The clinic has a total of about 600 patients. The site will recruit participants according to the main study protocol using the inclusion and exclusion criteria stated. They will collect detailed locator information including addresses, telephone contact, and next of kin to facilitate phone and/or physical tracing during the follow-up phase of the study. LSHTM Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
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: HS5274ES

Primary Objective: 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 HCPmanaged (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).

Secondary Objective: Key secondary objective:

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 screening 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 HCPmanaged (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.

To evaluate the duration of 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.

To evaluate the safety and immunogenicity of crizanlizumab 5 mg/kg over the 2-year study
period.

To explore the efficacy of crizanlizumab 5 mg/kg over the 2-year study period.

To explore the proportion of VOCs that are selfmanaged without recommendations from HCP during the event, versus 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 treatment period of 52 weeks.

To explore the proportion of VOCs that are HCP-managed via remote consultation versus VOCs that are HCP-managed at a healthcare facility between treatment arms over the planned 52-week treatment period.

To explore the incidence rates of all VOCs,
VOCs that are HCP-managed at a healthcare
facility, VOCs that are HCP-managed via remote consultation, VOCs that are HCP-managed,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, by treatment arm.

To explore quality of life in each treatment arm (ASCQ-Me Short Forms: emotional impact, sleep impact, and joint stiffness).

To explore healthcare facility resource utilization (inpatient hospital admission, emergency room visit, urgent care/clinic visit, infusion center visit)between treatment arms over
the planned 52-week treatment period.

To explore the pharmacokinetics (PK) profile of crizanlizumab at 5 mg/kg.

To explore the pharmacodynamics (PD) (Pselectin inhibition) of crizanlizumab at 5 mg/kg.

To explore biomarkers [p-selectin (free and
total)] and CRP].

To explore exposure-response relationship.
Wakiso, Lubowa
Uganda 2025-04-02 8:43:56 2028-04-02 10-15 SCD participants aged 12 years and older who experienced at 4-12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in the 12 months prior to screening visit. Participants who have been taking HU/HC for at least 6 months at a stable dose for at least 3 months and plan to continue taking at the same dose and schedule until the participant has reached 52 weeks of study treatment will be permitted. Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to the screening visit. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Ronald Moses Galiwango
ID: UNCST-2024-R015239
INTEGRATED FEMALE SEXUALLY TRANSMITTED INFECTION TESTING FOR HIV EPIDEMIC CONTROL THROUGH PREP (IN-STEP)
REFNo: HS5715ES

a) To conduct an individually randomized effectiveness implementation trial of SRST plus cSTI testing to increase PrEP use among African women at high HIV risk.
b) To perform a mixed-methods, implementation science evaluation of female cSTI testing for improving PrEP use for HIV prevention.
c) To determine the most efficient, population-level female cSTI testing strategies to reduce HIV incidence in African settings.

Rakai, All parishes in the mentioned subcounty
Kyotera, All parishes in the mentioned subcounty
Lyantonde, All parishes in the mentioned subcounty
Uganda 2025-03-25 11:13:20 2028-03-25 5000 The targeted population is adolescent girls and women aged 15 - 39 years of age National Institute of Allergy and Infectious Diseases, R01AI177132 (Financial support); Abbott Laboratories (Material support) Medical and Health Sciences Clinical Trial Non-degree Award
Bruce Kirenga J
ID: UNCST-2019-R001460
SURVEY, SAFETY AND EFFICACY OF HERBAL PRODUCTS USED FOR MALARIA PROPHYLAXIS AND TREATMENT IN UGANDA.
REFNo: HS5468ES

To conduct a survey of herbal medicinal products used for malaria prophylaxis and treatment, evaluate their safety and prophylactic efficacy among school-age children (8-15yrs) in Kibuku district, Uganda.
1. To identify herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
2. To evaluate the artemisinin content of herbal medicinal products used by communities for malaria prophylaxis and treatment in Uganda.
3. To determine the antiplasmodial activity (IC50) of herbal medicinal products used for malaria prophylaxis and treatment in Uganda.
4. To evaluate the safety of herbal medicinal products used for malaria prophylaxis among school age children (8-15 years) in Kibuku district in eastern Uganda.
5. To determine malaria incidence among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku district in eastern Uganda.
6. To determine prevalence of parasitaemia among school age children (8-15 years) receiving selected herbal medicinal products for malaria prophylaxis compared to monthly Dihydroartemisinin-Piperaquine (DP) in Kibuku in eastern Uganda.

All Districts, NA
Kibuku,
Uganda 2025-03-14 19:08:33 2028-03-14 222 participants for the trial (111 per study arm) 8 to 15 years of age, both male and female, all tribes accessible. The Government of Uganda through the Science, Technology, and Innovation Secretariat - Office of the President (STI-OP) Medical and Health Sciences Clinical Trial Non-degree Award
Victor Musiime
ID: UNCST-2021-R013794
A global phase 3, randomised, double-blind and placebo-controlled study evaluating the efficacy and safety of etavopivat in adolescents and adults with sickle cell disease
REFNo: HS5637ES

1. To demonstrate superiority of
treatment with etavopivat
versus placebo in adolescents
and adults with SCD.
2. To evaluate clinical efficacy
measures of etavopivat treatment
versus placebo in adolescents
and adults with SCD
3. To assess clinically meaningful
improvement in fatigue and
functional exercise capacity
and QOL measures of
adolescents and adults with
SCD taking etavopivat
treatment compared to placebo
Wakiso, Sabagabo
Kampala, Mulago
Jinja, Jinja
Uganda 2025-03-14 17:26:26 2028-03-14 408 12-17, 18 and above, male female all tribes Novo Nordisk A/S Medical and Health Sciences Clinical Trial Non-degree Award
Margaret Nagawa
ID: UNCST-2022-R009705
EARLY NUTRITIONAL INTERVENTION FOR NUTRITIONALLY AT-RISK INFANTS UNDER 6 MONTHS OF AGE TO REDUCE MALNUTRITION IN THE FIRST YEAR OF LIFE
REFNo: HS3503ES

5. To assess the maternal and health worker perceptions on the integrated intervention package.,4. To assess the effect of an early integrated family intervention program for LBW and undernourished children u6m on growth in the first year of life.,3. To understand the barriers and facilitators to the integration of maternal mental health care and community-based management of malnutrition in infants u6m of age.,2. To assess the prevalence of maternal mental health among caregivers of u6m infants.,1. To determine the factors associated with malnutrition among infants u6m of age and challenges caregivers of LBW and undernourished infants face. ,2. To assess the prevalence of malnutrition among infants u6m and their associations, To assess the effect of an early integrated nutrition intervention for nutritionally at-risk infants u6m of age in reducing malnutrition in the first year of life. ,
Adjumani, Adjumani
Uganda 2025-03-14 16:37:34 2028-03-14 300 mother baby pairs Infants under 6 months of age. and caregivers of infants under six months of age. sex: males and females Tribe: refugees and host communities self funded Medical and Health Sciences Clinical Trial Degree Award
Schola  Matovu Nakachwa
ID: UNCST-2022-R011040
Development and Testing of BAJJAJJA: An Intervention to Promote Economic Empowerment and Health of Grandmothers who Provide Primary Care for Grandchildren in Uganda
REFNo: SS3611ES

Main Objective
The study’s objective is to refine and test the feasibility and acceptability of my innovative intervention, BAJJAJJA: Building A Joint Action for JaJJAs which couples an income- generating activity (IGA) with nurse-facilitated group health coaching. This objective is informed by the NIH Stage Model of behavioral intervention development.

Specific Objectives
Aim 1: To refine and adapt the BAJJAJJA intervention through a collaborative and iterative feedback process with a diverse community group of 18 members. In a series of sessions, I will iteratively engage diverse community groups (nurses, local officials, IGA experts, and GMCs) and use cognitive interviewing to gain feedback on the appropriateness of study measures, content, delivery, and intervention format.
Aim 2: To test the feasibility, acceptability, and preliminary efficacy of the BAJJAJJA intervention in improving economic and health outcomes among 24 Ugandan GMCs. Over a 12-month period and at three time points of assessment, I will use a mixed methodology with a quasi-experimental design to collect data that will be examined to assess the feasibility, acceptability, and preliminary efficacy of the intervention on participants’ household income and health outcomes.
Aim 3: To explore the barriers and facilitators to (3a) maintenance of the BAJJAJJA individual intervention benefits (e.g., physical activity level and frequency) and (3b) sustainability of the IGA activities (e.g., grandmothers’ accessing external supports such as community resources) at 6 months post-intervention. Following a mixed methods approach, the 24 GMCs from Aim 2 will be interviewed to further evaluate the long-term maintenance and sustainability of the intervention. Health assessments, interviews, and IGA site visits will be used to explore the intervention outcomes and benefits at 6 months post-intervention.

Buikwe, Kiteza
USA 2025-03-10 12:23:29 2028-03-10 24 Grandmother Caregivers 1. Grandmothers: Ugandan GMCs who are (a) > 50 years (considering the average reproductive age range in Uganda of 15-49 years), (b) Luganda-speaking (commonly spoken language), (c) primary caregivers for at least one minor grandchild (< 18 years) for > 6 months, and (d) able to perform activities of daily living (e.g., cooking, bathing) without assistance. 2.Community Advisory Board: 10 key informants: Local elected community leaders ( LCs), healthcare professionals, nurses from local health centers and a village health team member, IGA experts, and grandmothers. Participants will be identified by LC leaders or referred by other participants using a snowball sampling technique. Participants are female (grandmother caregivers) with no tribal restrictions as long as she can speak luganda NIH JOHN E FORGATY International Center Social Science and Humanities Clinical Trial Non-degree Award
Pauline Byakika-Kibwika
ID: UNCST-2019-R001206
Randomized trial to evaluate the efficacy and safety of select therapeutic agents in the treatment of Ebola Disease (TOKOMEZA - Ebola Disease Therapeutics)
REFNo: HS5686ES

This is an open-label, adaptive, randomised platform clinical trial to evaluate the impact of 278 potential treatments on mortality in patients with Ebola Disease
All Districts, Not specific
Uganda 2025-03-07 18:39:19 2028-03-07 180 All age groups, sex, and tribes that are eligible for recruitment. Ministry of Health of Uganda and World Health Organization Medical and Health Sciences Clinical Trial Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB IN COMBINATION WITH PHESGO→ VERSUS PLACEBO IN COMBINATION WITH PHESGO→ AS MAINTENANCE THERAPY AFTER FIRST LINE INDUCTION THERAPY IN PARTICIPANTS WITH PIK3CA‑MUTATED HER2‑POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER (INAVO122)
REFNo: HS5649ES

This study will enrol particpants
Kampala, Mulago
Uganda 2025-03-07 18:26:49 2028-03-07 20 Adult females above 18 years of age with breast cancer F.Hoffman La Roche Medical and Health Sciences Clinical Trial Non-degree Award
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
ISMAHIL ADENIYI ADEKUNLE
ID: UNCST-2024-R002602
EFFECTS OF ETHYL-ACETATE FRACTION OF Bidens pilosa LEAVES ON TESTES AND PITUITARY GLAND OF MALE MICE EXPOSED TO BISPHENOL A
REFNo: HS5372ES

The purpose of this study is to evaluate the impact of B. pilosa on testicular integrity and the pituitary gland of male mice exposed to BPA.
1.3.1 Specific Objectives
i. To assess the effect of B. Pilosa on spermatogenic metrics of the testes such as sperm motility, sperm count, morphology, agglutination, and vitality using routine and extended semen analysis.
ii. To determine the impact of B. pilosa on serum concentration of follicle-stimulating hormone, testosterone, and luteinizing hormone using enzyme-linked immunosorbent assay (ELISA) following BPA exposure.
iii. To assess the changes in testicular oxidative stress biomarkers (such as CAT, SOD, and GSH) and lipid peroxidation using MDA.
iv. To assess the histology, histochemical, and immunohistochemical changes in the testes and pituitary gland following treatment with B. pilosa in BPA exposure using Masson Trichrome, Periodic Acid Schiff (PAS), Hematoxylin and Eosin (H&E), Caspase 3, antiproliferating cell nuclear antigen (PCNA), Bcl-2, alpha-smooth muscle actin (α-SMA), and Bax.

Bushenyi, Kampala International University, Western Campus
Nigeria 2025-03-03 11:40:21 2028-03-03 30 animals Animals will be divided into five groups, with six animals in each group (n=6). Group 1 is the control, 2 ml/kg bw of distilled water. Group 2—100 mg/kg/day of BPA Group 3—100 mg/kg/day of BPA + low dose of B. pilosa (250 mg/kg). Group 4—100 mg/kg/day of BPA + medium dose of B. pilosa (500 mg/kg). Group 5: 100 mg/kg/day of BPA + high dose of B. pilosa (1000 mg/kg) All administration will be done via oral administration for 5 weeks (35 days) because sperm maturation in mice takes about 35 days; B. pilosa will be administered after 1 hour of treatment with BPA. At the conclusion of the administration period on the 35th day, as per the approved protocol, animals from all groups will be euthanized after receiving ketamine. Blood samples will be collected from the animals via cardiac puncture and transferred to a plain sample bottle to allow coagulation of the cellular components of the blood. The blood sample is then centrifuged for the collection of serum. The collected serum will be used for hormonal assay (testosterone, LH, and FSH) and determination of oxidative stress biomarkers (CAT, SOD, and GSH). Adeniyi A. Ismahil (self sponsored) Medical and Health Sciences Clinical Trial Degree Award
Nazarius Tumwesigye Mbona
ID: UNCST-2019-R000664
COBIHA- A COMMUNITY BASED INTERVENTION AGAINST HARMFUL USE OF ALCOHOL IN A RURAL SETTING: A pilot study around lake Bunyonyi in Kigezi, Uganda
REFNo: HS5521ES

2.To explore reasons for harmful use of alcohol, and perceptions on effective and acceptable ways of reducing this.,1.To conduct a pilot survey to establish the level of harmful use of alcohol and factors associated with the behaviour , to fill the evidence gap on effective community interventions, the current burden of harmful use of alcohol, and community perceptions of the burden of harmful alcohol use in rural Uganda,
Kabale, Mwendo
Kabale, Bwama
Rubanda, Kagarama
Rubanda, Butobole
Rubanda, Kabere
Uganda 2025-02-20 18:51:21 2028-02-20 0 All adults aged 18 and above with alcohol harmful use National Institute for Health and Care Research Medical and Health Sciences Clinical Trial Non-degree Award
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
EVA NATUKUNDA
ID: UNCST-2020-R014330
An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
REFNo: HS4706ES

To provide Continued Access to Study Drug to Participants Who Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
Kampala, lubowa
Uganda 2024-09-25 12:50:13 2027-09-25 86 5 to 18 years Gilead sciences Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
ACTG NEW WORK CONCEPT SHEET (NWCS) 575: Evaluation of biomarkers to predict TB-IRI
REFNo: HS4876ES

1. Determine whether higher levels of a set of biomarkers in people with HIV and tuberculosis prior to ART initiation may predict the development of TB-IRIS, particularly severe IRIS requiring corticosteroid treatment
2. Assess whether these biomarkers decrease between study entry and ART initiation in the deferred arm (i.e. with more prolonged anti-tuberculous therapy duration)
3. Determine whether these biomarkers can be predictive of other severe outcomes especially deaths.

Uganda 2024-09-11 14:10:40 2027-09-11 1,000 A5221 participants were National Institute of Allergy and Infectious Diseases (NIAIDS) 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
Milton Musaba Wamboko
ID: UNCST-2019-R000825
Effectiveness and Safety Dosing of Sodium Bicarbonate in Women with Obstructed Labor in Eastern Uganda: A Phase III Randomized placebo-controlled Trial (SoBicOL- II Study)
REFNo: HS3885ES

General objective
To determine the efficacy and safety of a preoperative infusion of sodium bicarbonate on pH and lactate levels (metabolic acidosis) among women with obstructed labour.
Specific objectives
1. To determine the efficacy of a preoperative infusion of sodium bicarbonate on acidosis, compared with placebo among women with obstructed labour (OL).
2. To determine the safety of a preoperative infusion of sodium bicarbonate compared with placebo among women with obstructed labour (OL).

Mbale, Kawempe
Uganda 2024-08-29 18:40:41 2027-08-29 280 Obstructed labour will be diagnosed by either an obstetrician or medical officer using a definition of the American Association of Obstetricians and Gynaecologists (ACOG). In the first stage of labour, the participant should have cervical dilatation >6 cm with ruptured membranes, adequate contractions lasting >4 hours with no change in cervical dilatation or delay in the second active stage of labour (nullipara >2 hours, multipara >1 hour) with adequate uterine contractions. In addition, any two of: the obvious signs of severe obstruction such as caput formation, severe moulding, Bandl’s ring, subconjunctival haemorrhages or an oedematous vulva. Busitema University 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
Ruth Namazzi
ID: UNCST-2020-R014305
Zinc for Infection Prevention in Sickle cell anemia ZIPS-2
REFNo: HS4824ES

The primary objective of the study is to determine if zinc supplementation at 20mg daily is safe and efficacious at reducing all-cause infection in Ugandan children 1.00-4.99 years of age with SCA.Secondary objectives 1. To determine the incidence of adverse events requiring discontinuation of study drug in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 2. To determine the incidence of stroke or death in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 3. To determine the incidence of infections requiring hospitalization in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 4. To determine the incidence of vaso-occlusive crises in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 5. To determine the change in transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 6. To determine change in serum zinc deficiency status from enrollment to 6-month study endpoint in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 7. To determine the incidence of serious adverse events in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo 8. To determine the incidence of adverse events in children ages 1-4.99 supplemented with 20mg of daily zinc vs placebo
Jinja, Kakindu
Uganda 2024-08-28 17:29:12 2027-08-28 100 Children with confirmed SCA between 1.00 and 4.99 years of age, living in the malaria endemic area of mid-eastern Uganda, who attend the Nalufenya Sickle Cell Clinic, Jinja Regional Referral Hospital whose caretakers’ consent to study participation CURES WITHIN REACH, INDIANA UNIVERSITY Medical and Health Sciences Clinical Trial Non-degree Award
Herbert Ainamani Elvis
ID: UNCST-2020-R014674
The Impact of Self Help Plus and Climate Smart Agriculture on Mental Health and Food Security in the Rhino and Nakivale Refugee Settlements of Uganda
REFNo: HS4691ES

To compare the uptake of HGI between the mothers in the combined intervention group (HGI & SH+) with those in the HGI group living in Nakivale refugee settlement,To assess the effect of SH+ on the development of children aged 3-6 years belonging to participating mothers living in Rhino and Nakivale refugee settlements,To assess the effect of SH+ on the mental health of mothers with children aged 3-6 years living in Rhino and Nakivale refugee settlements ,To assess the perceptions and attitudes towards a home gardening intervention (HGI) among participating mothers living in Nakivale refugee settlement,To assess the effectiveness of Self Help Plus (SH+) and home gardening on maternal mental health, food security and child development in the Rhino and Nakivale refugee settlements of Uganda,
Uganda 2024-08-26 14:58:27 2027-08-26 900 The target population of the proposed research project consists of refugee mothers (age 18+) with children aged 3-6 years, living in the Nakivale and Rhino refugee camps in Uganda. In Nakivale, the study will recruit 900 mother-child dyads across 30 villages, while in Rhino, 720 dyads from 24 villages will participate. Participating mothers in randomly selected intervention villages will be the recipients of the mental health and/or smart farming intervention. Outcomes will be measured at the level of the mother, the child, and the household. Uppsala University Medical and Health Sciences Clinical Trial Non-degree Award
Monicah Agaba
ID: UNCST-2024-R004221
The Health-Beauty Paradox among Women in Mbarara City Uganda
REFNo: HS4708ES

iii. To characterise the cardio-metabolic profile of WRA.,ii. To document the risk behaviours and their factors related to these societal beauty perceptions.,i. To document societal beauty perceptions and their determinants.,To understand what, why and how the health-beauty paradox is so deeply entrenched in the culture.,
Mbarara, Sampled
Uganda 2024-08-26 10:18:37 2027-08-26 300 For the qualitative study, we target both women and men aged 15 up to 65 years who are residents of Mbarara City. For the quantitative study, we target only women of reproductive age (15 to 49 years) who are residents of Mbarara City. For both studies, their ethnicity is not a key inclusion or exclusion criterion. Global Minds Scholarship and Healthy Diets for Africa project Medical and Health Sciences Clinical Trial Degree Award
Rebecca Nuwematsiko
ID: UNCST-2022-R010501
Effect and implementation factors of a contextually adapted short message service or phone call intervention to reduce loss to follow-up among presumptive TB patients in North Central Uganda
REFNo: HS3000ES

1.To determine the proportion of pre-diagnosis LTFU among presumptive TB patients and influencing factors in North Central Uganda (Sub-study 1). 2.To explore stakeholder’s perceptions on use of an SMS or phone call intervention to reduce LTFU among presumptive TB patients in health care facilities in North Central Uganda and contextually adapt the interventions (Sub-study 2). 3.To assess the effect of a contextually adapted SMS or phone call intervention to reduce LTFU among presumptive TB patients in health care facilities in North Central Uganda (Sub-study 3). 4.To explore factors that influence implementation of a locally adapted SMS or phone call intervention to reduce LTFU among presumptive TB patients in North Central Uganda (Sub-study 3). 5.To synthesize evidence on effectiveness of mHealth interventions to reduce LTFU in the TB presumption phase in LMICs (Sub-study 4)
Mukono, Mukono
Buikwe, Kawolo
Mityana, Mityana
Uganda 2024-08-22 13:00:28 2027-08-22 1410 This will include presumptive TB patients aged 18 years and above who present to the study facilities during the study period and do not complete diagnosis on the same day of the hospital visit. Inclusion criteria A presumptive TB patient who is;  Aged 18 years and above  Current resident in the study district  Willing to sign informed consent  Owning a personal mobile phone (The patient should be in possession of the phone at the time of screening)  Being able to read  Those sent for GeneXpert testing  Presumed for TB within 12 hours  Patient has not completed TB diagnosis on the same day  Speaks or reads English or Luganda MILEAGE4TB project hosted at Makerere University School of Public Health Medical and Health Sciences Clinical Trial Degree Award
Grace Kisitu Paul
ID: UNCST-2024-R004102
Universal2: Pharmacokinetics, safety and acceptability of a solid paediatric fixed-dose combination of darunavir/ritonavir (DRV/r) 120/20mg for children living with HIV
REFNo: HS4762ES

To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To evaluate the pharmacokinetics and safety of DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to Less than 25 kg

To evaluate the acceptability of DRV/r tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To evaluate the short-term efficacy of the DRV/r 120/20 mg tablets in children greater than or equal to 3 years of age and weighing 10 to less than 25 kg

To describe RTV PK parameters as well as darunavir unbound plasma concentrations.

Uganda 2024-08-22 11:45:22 2027-08-22 50 Children with HIV, from 3 years of age, requiring DRV/r: • weighing 10 to less than 25 kg with 1 or 2 DRV resistance-associated mutations (RAM) * Or • weighing 10 to less than 20 kg requiring DRV/r, with no DRV RAM* *DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V Fondazione Penta ETS Medical and Health Sciences Clinical Trial Non-degree Award
Agaba Katureebe Ishmael
ID: UNCST-2024-R004089
Getting a GRIP on Hypertension in Uganda: Giving Repetitive Isometric Exercise for Blood Pressure Control (GRIP in Uganda)
REFNo: HS4712ES

To assess knowledge, attitudes, and practices (KAP) about HTN and experience with IHT (if applicable) ,To measure HTN medication adherence for those prescribed HTN medication during their follow-up, which will be measured through pill counting (counting the remaining amount of pills for prescribed medication).,To assess the need for HTN medication at endline, as per clinical and MOH guidelines, which will be measured through changes in BP levels at week 12,To evaluate the effects of Isometric Hand Training (IHT) on resting diastolic Blood Pressure when compared to standard care after 12 weeks ,To evaluate the effects of Isometric Hand Training (IHT) on resting Systolic Blood Pressure when compared to standard care after 12 weeks ,To determine the efficacy of Isometric Hand Training (IHT) in a population of Hypertension (HTN) patients compared to standard care after 12 weeks of care,
Jinja, Ivunamba
Uganda 2024-08-22 11:38:26 2027-08-22 250 adult participants We intend to enroll 250 adult participants men and women aged 18 years and above. Participants will be persons who seek care at the Soft Power Mukagwa Allan Stone community clinic in Kyabirwa jinja. These come from Jinja and the neighboring districts of Iganga, Luuka, Kamuli and Mayuge in East Central sub-region. The area is predominantly inhabited by Basoga and then minority Baganda, Bagisu, Banyole etc. Eligibility criteria Inclusion criteria are: 1) diagnosis of stage 1 HTN (BP >140-159/90-99 mmHg ), which is based on the clinic and MOH definitions , 2) not currently taking HTN medication, 3) not having been on HTN medication in the past 3 months, and 4) age > 18 years and older. Exclusion criteria are: 1) diagnosis of stage 1 HTN and currently taking HTN medication, 2) diagnosis of stage 2 HTN, 3) diabetes, 4) history of recent myocardial infarction (in the past year), 5) congestive heart failure, 6) complete heart block, 7) unstable angina, 8) Glomerular Filtration rate of 90 or lower, 9) any pregnancy associated HTN, 10) any limitation (e.g., limited hand mobility) preventing proper performance of IHT exercise, and 11) any other condition that alters autonomic nervous system function. Canadian Institutes of Health Research (CIHR) Medical and Health Sciences Clinical Trial Non-degree Award
Proscovia Nabunya
ID: UNCST-2019-R000970
Testing the Feasibility and Acceptability of a Combination Intervention to Address Mental Health among Refugee Youth in Uganda
REFNo: SS2834ES

This proposed two-year study will be conducted in two phases. The first phase seeks to understand whether the COVID-19 pandemic had differential impact on refugee youth living in different settings. The second phase will test the feasibility and acceptability of an innovative combination intervention that has not been previously tested among refugee youth to address psychological problems that have increased since the onset of the COVID-19 pandemic. Aim 1. To examine the mental health impact of COVID-19 on refugee youth living in Bidibidi refugee settlement compared to refugee youth living in urban centers (Arua town) in northern Uganda. Aim 2. To test the feasibility, acceptability and preliminary short-term impact of an innovative intervention combining the youth readiness intervention (YRI) with youth development accounts and financial literacy training (YDA-FLT) to address the mental health impact of COVID-19 among refugee youth living in Bidibidi refugee settlement in northern Uganda.
Uganda 2024-08-19 11:03:04 2027-08-19 200 The total sample size needed for the Refugee Youth COVID-19 study is 200 refugee youth, 15 to 24 years of age. Specifically, we will recruit 100 refugee youth from the five zones within Bidibidi Refugee settlement and another 100 youth among refugee youth living in Arua town (urban center). Youth will be recruited from centrally located ration distribution centers in the settlement, through churches, and youth advocacy groups led by refugee youth in Arua town that we will partner with. For the pilot RCT component, we will only include the 100 participants in Bidibidi refugee settlement with 50 randomized to the treatment group and the other 50 randomized to usual care group. Washington University in St. Louis Social Science and Humanities Clinical Trial Non-degree Award
Peter Olupot-Olupot Olupot
ID: UNCST-2020-R014798
SMAART-MAP trial Severe Malaria A Research and Trials consortium - Multisite Adaptive Platform trial
REFNo: HS4547ES

OBJECTIVES
The objective of the SMAART-MAP trial is to identify promising adjunctive therapies to take forward into a large Phase III trial in severe malaria with a mortality endpoint. The adaptive platform design enables additional domains to be added so a range of adjunctive therapies can be tested, across multiple clinical presentations of severe malaria, in a timely manner.

PRIMARY OBJECTIVE(S)
To explore within each domain the therapeutic efficacy of the intervention using an early indicator such as a biomarker or clinical assessment at 24-72 hours.

SECONDARY OBJECTIVE(S)
 To assess the impact of the interventions on clinical outcomes (readmission and
mortality) on all children 28 days and 90 days after randomization
 To assess the impact of the interventions on Grade 3 or 4 adverse events, and adverse
events of any grade related to the interventions or comparators.
 To assess the impact of proposed definitions for severe malaria based on platelet counts
≤150,000/µL and plasma pfHRP2 concentrations ≥800 ng/mL on differences between
randomized groups
 In a sub study, to determine the performance characteristics of a POC pfHRP2 test
compared with quantitative plasma pfHRP2 concentrations determined from plasma.

Mbale, North central
Soroti, Pioneer Ward
Agago, Oreet
Uganda 2024-08-16 11:01:14 2027-08-16 150 per domain Hospitalized children with severe malaria Imperial College London Medical and Health Sciences Clinical Trial Non-degree Award
VINCENT MUBANGIZI
ID: UNCST-2024-R004232
Opti-MaP (Optimising Implementation of Maternal and Perinatal Death Surveillance and Response to prevent avoidable future deaths in Uganda
REFNo: HS4630ES

To review existing tools, develop and adapt a harmonised toolbox of resources to optimise MPDSR implementationTo co-design customised an "intervention package" using the toolboxTo evaluate effectiveness and cost-effectiveness of the "customised intervention package" to reduce perinatal and maternal mortalityTo develop and adapt a harmonised toolbox of resources to optimise MPDSR implementation
Kamwenge, All parishes
Kyenjojo, All parishes
Lyantonde, All parishes
Uganda 2024-08-06 18:02:24 2027-08-06 For work packages 2-7, the sample size will be determined when the interviewers reach a point of saturation. For the intervention phase (work package 8), the estimated sample size is 4032. Adult males and females plus emancipated minors in the study area regardless of their tribe will be involved in the study. We will also interview key stake holders in the central ministries and bodies. We will interview persons who have lost a women due to pregnancy related causes or had a still birth or a baby died within 28 days of birth Merlin L Willcox Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-Acting Combination Therapy Studies.
REFNo: HS4452ES

The secondary objective is to assess the long-term safety and tolerability of CAB LA + RPV LA by evaluating the incidence of serious adverse events (SAEs), pregnancies, adverse events (AEs) leading to discontinuation of CABLA +RPV LA, and AEs considered to be related to the study intervention.,The primary objective of the study is to provide continued CAB LA + RPV LA access to participants who were enrolled and treated with CAB LA + RPV LA in the parent studies, and who, at the time of roll-over, experience and are expected to continue to experience clinical benefit from this treatment.,
Wakiso, Katabi
Wakiso, Lubowa
Kampala, Mulago
Kabarole, Buyinga
Uganda 2024-08-06 17:32:50 2027-08-06 710 in Uganda Virologically suppressed adults who have had a detectable HIV viral load in prior 2 years of taking first-line ART or who have disengaged from HIV care. Janssen-Cilag International NV Medical and Health Sciences Clinical Trial Non-degree Award
alfred bulamu
ID: UNCST-2023-R008638
Uganda Translational Breast Cancer Screening Research Center with Innovations in MRI and Genetic Testing.
REFNo: HS4689ES

Implementation of breast MRI with genetic testing as BC screening method for women at high risk of BC by July 2029 (Phase 6) , Continuous Trainings for radiologists, radiographers and laboratory staffs on the modern technologies of MRI and Genetic testing (phase 3 to phase 6) ,Evaluating the feasibility of screening BC using MRI and genetic testing for high risk women by December 2028 (phase 5),Large scale education of the community about BC by July 2028 (phase 3 and phase 4).,Large scale determination of the utility of genetic testing as a screening modality for BC in Uganda by perform mutational genetic analysis for women at high-risk aged19 years to 80 years by July 2028 (phase 3 and phase 4) , Large scale determination of the utility of quantitative breast MRI for screening women at high risk BC aged 19 years to 80 years by July 2028 (phase 3 and phase 4) ,Training of the users on equipment i.e. Radiologists, Radiographers and laboratory staffs by 2025 (phase 2) ,Securing and installation of lab equipment for genetic testing by 2025 (Phase 2,Securing and installation of MRI with Breast coils by July 2025 (Phase 2),To build capacity for 20 laboratory health care workers in genetic testing technologies by December 2023 (phase 1).,To build capacity for 30 radiology health professionals in modern breast Imaging with MRI by December 2023 (Phase 1),To determine the utility of quantitative breast MRI for screening women at high risk breast cancer aged 19 years to 80 years by July 2024 (phase 1),To determine the utility of genetic testing as a screening modality for BC in Uganda by perform mutational genetic analysis for women at high-risk of BC aged 19 years to 80 years, by July 2024 (phase1),To build a long-lasting infrastructure for research, clinical screening in Uganda and training using modern technologies. ,To offer improved access to Breast Cancer screening in Uganda through quantitative MRI and genetic testing research center,
All Districts, All parishes
Uganda 2024-08-06 17:27:31 2027-08-06 100 participants All women at the risk of breast Cancer between the Ge of 19 year to 80years of all the tribes in the different regions Kiphart Foundation Medical and Health Sciences Clinical Trial Non-degree Award
Moses Oketch
ID: UNCST-2024-R004313
Long-Term Impacts of Improved Childhood Literacy
REFNo: SS2796ES

Economic situation,
Amolatar,
Dokolo,
UK 2024-08-05 14:01:33 2027-08-05 6581 Former participants of a study on the impact of an early-grade literacy intervention. The study was implemented from 2009 to 2011. The respondents are aged between 19 and 24 years old, with an average age of 21 years. Center for Global Development Social Science and Humanities Clinical Trial Non-degree Award
Jenny Löfgren
ID: UNCST-2024-R005428
Outcomes of paediatric inguinal hernia repair performed by surgeons versus medical officers
REFNo: HS4508ES

Calculate and compare costs and cost-effectiveness between the two groups. ,Compare patient related outcomes between the group that has been operated on by medical officers versus those who were operated by general surgeons. ,The general objective of the proposed study is to investigate the possibility of task sharing between general surgeons and medical officers in inguinal hernia repair in children in Uganda. ,
Soroti,
Mubende,
Iganga,
Sweden 2024-07-23 15:30:50 2027-07-23 341 Children, both girls and boys, 1-12 years old. Swedish Research Council Medical and Health Sciences Clinical Trial Degree Award
Nura Izath
ID: UNCST-2022-R009201
Autothermo-a wearable continuous temperature measuring bracelet with a central display screen.
REFNo: HS3034ES

To assess the performance of Autothermo- a wearable continuous temperature measuring bracelet and a central display screen in comparison to the standard thermometer.,To assess the feasibility and acceptability of Autothermo among health workers and parents/caregivers of admitted neonates at Mbarara Regional Referral Hospital(MRRH).,
Mbarara, Kamukuzi
Uganda 2024-07-22 16:57:35 2027-07-22 The sample size of the health workers: Convenient sample of 4 out of 6 health workers engaged in the management and care of newborns admitted at Neonatal Intensive Care Unit-MRRH will be enrolled in the study. These study participants who will be nurses on duty will observe the use of Autothermo, ask a few questions and document findings at the end of each shift. The remaining two nurses will be recruited as study research nurses who will enroll and use Autothermo to monitor temperatures of the admitted newborns during the study period. The sample size for parents or caregivers will be calculated basing on the Kish and Leslie where P (0.5) will be the probability of parents or caregivers who will express willingness to have their newborns’ temperatures monitored with Autothermo and q (1-p) will be the probability of those who will not express willingness to use Autothermo. The study will use a precision of 0.126 and a Z of 1.96 giving a total of 60 parents or caregivers to be recruited into the study. Taking Feasibility and Acceptability of Autothermo: The study will include health workers and parents or primary caregivers of newborn. Parents and caregivers who are 18 years and above will be recruited and all health workers in the Neonatal Intensive Care Unit. The parents or caregivers will be informed that the Autothermo bracelet will be removed at any time at their request. Autothermo Performance Assessment: All neonates (0 to 28 days) admitted to the neonatal unit of MRRH during the study period will be screened for inclusion into the study. Ministry of ICT and National Guidance Medical and Health Sciences Clinical Trial Non-degree Award
Grace Kisitu Paul
ID: UNCST-2024-R004102
UNIVERSAL1: Pharmacokinetic study of an optimized dose ratio of dolutegravir/emtricitabine/tenofovir alafenamide fumarate: expediting a UNIVERSAL first line regimen for all children living with HIV in Africa
REFNo: HS4280ES

Primary objective:
To evaluate the pharmacokinetics and short-term safety of DTG and FTC/TAF administered to children living with HIV using a novel dose ratio

Secondary objective:
To evaluate the short-term efficacy of DTG and FTC/TAF
formulations in children using a novel dose ratio

Uganda 2024-07-19 3:45:20 2027-07-19 50 Children aged between 28 days and ≤10 years old weighing ≥3 to <25kg diagnosed with HIV. Fondazione Penta ETS Medical and Health Sciences Clinical Trial Non-degree Award
Janet Nakigudde
ID: UNCST-2019-R000444
PROMOTING MENTAL HEALTH OF TEACHERS AND CAREGIVERS USING A PERSONALIZED MHEALTH TOOLKIT IN UGANDA
REFNo: HS4431ES

3. To examine feasibility of mWEL-T and mWEL-P with parents and teachers from urban and rural regions (including examining feasibility of the implementation procedures and intervention efficacy) (n=160, 80 parents and 80 teachers from urban and rural regions).,To conduct a user-centered testing study to optimize usability of the Teacher and Parent versions of mWEL- mWEL-T and mWEL-P,1. To build a school system capacity (by establishing a cross-discipline digital health leadership & learning collaborative (n=10) and training a group of peer-community health workers (P-CHW) (n=30; 15 peer teachers and 15 peer parents) to implement the mWEL that is developed,The aim of the study is to test mWEL a newly developed mobile app and user-engagement strategies for mental health management and promotion targeting teachers and parents,
Kampala, kibuli
Nakaseke, Nakaseke
Uganda 2024-07-17 14:03:01 2027-07-17 For the proposal sample size N=160 for the full sample The study will enroll parent, teachers and caregivers of children. We shall consider parents who are at least 18 years old, and have a child aged 6-14 years in the enrolled school This study is sponsor by the United States National Institute of Mental Health through a collaboration with New York University, Department of Population Health, New York School of Medicine and Makerere University College of Health Sciences, Department of Psychiatry Medical and Health Sciences Clinical Trial Non-degree Award
Eugene Ruzagira
ID: UNCST-2023-R008282
Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)
REFNo: HS4366ES

Overall Objective
To assess effectiveness and implementation of long-acting cabotegravir (CAB-LA) and oral Truvada (both daily and event driven) through comparison of uptake, retention in care, coital coverage, and participant choice.
Masaka, Masaka
Uganda 2024-07-02 15:08:06 2027-07-02 400 mobile men. HIV negative men aged 18+ years in South Africa and Uganda. Men who are mobile for work, and in the past 6-months have travelled for work or to find work and spent at least one night away from home for work-related purposes. Men male at birth, able and willing to provide informed consent and willing to have an HIV test. MRC/UVRI &LSHTM Uganda Research Unit Medical and Health Sciences Clinical Trial Non-degree Award
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