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  
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
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
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
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
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
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
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
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
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
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
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
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
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
Susan  Nabadda
ID: UNCST-2020-R014331
 CLINICAL PERFORMANCE EVALUATION (RETROSPECTIVE STUDY) OF THE STANDARD Q HIV/SYPHILIS/HBsAg TRIPLE TEST
REFNo: HS6651ES

Quantify the proportion of uninterpretable (Invalid) results to gauge operational feasibility based on the invalid rate.,Assess Inter-reader Variability among different operators to ensure consistency in test interpretation and hence reliability in real-world settings.,To assess the diagnostic accuracy of the STANDARD Q HIV/Syphilis/HBsAg Triple Test, a rapid chromatographic immunoassay for simultaneous detection of HIV-1/2 antibodies, syphilis (Treponema pallidum) antibodies, and hepatitis B surface antigen (HBsAg). ,
 Kampala, National Health Laboratory and Diagnostic Service, Ministry of Health
 Uganda 2026-02-12 13:03:06 2029-02-12 Sample sizes for each disease analyte are calculated to achieve 95% confidence intervals with ±5% margin of error for sensitivity/specificity estimates. Clinical performance will follow the WHO TSS-1, TSS-6 and TSS-13 which require a sample size of up to 1000 samples; to achieve a pre-test clinical performance assessment of the HIV/Syphilis/HBsAg rapid diagnostic test kit, 50 samples of each disease analyte category will be used. Stored samples for 18 years and above for both males and females for all tribes will be considered. This retrospective study shall use archived samples from the CPHL biorepository with proof that at the time of sample collection, the source of the selected sample signed a broad consent indicating acceptance of storage for future research use of the remnant of their collected sample. Samples shall be selected from already known specific disease-characterized sets of positive and negative HIV, Syphilis and HBsAg. Department of National Health Laboratory and Diagnostic Service, Ministry of Health Medical and Health Sciences Clinical Trial Non-degree Award
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
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
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
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
AGNES NAGGIRINYA BWANIKA
ID: UNCST-2019-R001126
 Evaluating the impact on 90-day survival of post-discharge follow-up strategies delivered to adult patients hospitalized with sepsis across a research network in sub-Saharan Africa [Call for Life – Sepsis (C4L-Sepsis)]
REFNo: HS6882ES

To compare baseline demographic and clinical characteristics between participants who were randomized and those who did not meet randomization criteria (screen failures),To evaluate participant quality of life at 28- and 90-days post discharge period within two study arms.,To evaluate the proportion of participants within the two study arms who require re-admission to hospital during the post-discharge period of 90 days,To evaluate proportion of participants within the two study arms who return for scheduled post discharge follow-up visits ,To evaluate the efficacy on 28-day mortality among participants hospitalized with sepsis randomized to receive one of two post discharge follow-up strategies – EDI versus EDI plus IVR tool,To evaluate the efficacy on 90-day post-discharge mortality among adult participants hospitalized with sepsis randomized to receive one of two post discharge follow-up strategies – EDI versus EDI plus IVR tool,III. To train clinical officers about vitamin D and its application in managing the co-morbidity illnesses under study. This involves training and mentoring of clinical officers so as to acquire knowledge about vitamin D especially in relation to its clinical effects and treatment of malaria, diabetes, HTN, UTIs, and post covid-19 syndrome. This will enable build enough human capacity and willingness to carry out more research about vitamin D.,To develop prototypes of the efficacy doses of vitamin D for each co- morbidity group. From objective II, the efficacy doses (values) of vitamin D will be recorded. Vitamin D prototypes containing different formulations for each co-morbidity illness will be developed. These will be in form of; solutions, powder and inhalers,To establish the efficacy of vitamin D to the co-morbidity illnesses. This involves giving different doses of vitamin D to study participants in each co- morbidity group in addition to the illness’ conventional drugs while monitoring for change using the monitors of change tests/investigations to ascertain these therapeutic effects of Vitamin D.,To develop prototypes of the efficacy doses of vitamin D for each co-morbidity group. ,To explore vitamin D’s therapeutic efficacy to the co-morbidity diseases (malaria, HTN, diabetes, UTIs and post covid-19 syndrome) under study,III. To train clinical officers about vitamin D and its application in managing the co-morbidity illnesses under study. ,II. To develop prototypes of the efficacy doses of vitamin D for each co-morbidity group,I. To establish the efficacy of vitamin D to the co-morbidity illnesses,To explore vitamin D’s therapeutic efficacy to the co-morbidity diseases (malaria, HTN, diabetes, UTIs and post covid-19 syndrome) under study. ,III. To train clinical officers about vitamin D and its application in managing the co-morbidity illnesses under study. This involves training and mentoring of clinical officers so as to acquire knowledge about vitamin D especially in relation to its clinical effects and treatment of malaria, diabetes, HTN, UTIs, and post covid-19 syndrome. This will enable build enough human capacity and willingness to carry out more research about vitamin D,II. To develop prototypes of the efficacy doses of vitamin D for each co-morbidity group. From objective II, the efficacy doses (values) of vitamin D will be recorded. Vitamin D prototypes containing different formulations for each co-morbidity illness will be developed. These will be in form of; solutions, powder and inhalers ,I. To establish the efficacy of vitamin D to the co-morbidity illnesses. This involves giving different doses of vitamin D to study participants in each co-morbidity group in addition to the illness’ conventional drugs while monitoring for change using the monitors of change tests/investigations to ascertain these therapeutic effects of Vitamin D.,To explore vitamin D’s therapeutic efficacy to the co-morbidity diseases (malaria, HTN, diabetes, UTIs and post covid-19 syndrome) under study. This will be achieved by clinical application of vitamin D, assessing and monitoring its effect in the treatment of the respective comorbidity illness as well as developing of different formulations of vitamin D that had effect in each co-morbidity group. ,
 Masaka, Kimanya
Kampala, Mulago 1
 Uganda 2026-01-30 19:36:32 2029-01-30 353 Male and Female adults ≥18 years of all tribes who can understand English and Luganda. Stephen Okoboi 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
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