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
Isaac Ssewanyana
ID: UNCST-2020-R014336
PERFORMANCE EVALUATION OF COVID-19 ANTIGEN RAPID DIAGNOSTIC TESTS
REFNo: HS1690ES

To determine the association of positive index test results with disease stage (days since symptom onset, e.g. acute, early, late), symptom severity and symptom severity.,To determine the diagnostic accuracy of SARS-CoV-2 Ag RDTs on a respiratory specimen (NP swab, OP swab, nasal swab, saliva), vs Cobas SARS-CoV-2 assay as performed in patients presenting with influenza-like illness.,
pakwach,
Kampala, Mulag0
Kampala, Kiruddu
Masaka, Masaka
Mbarara, Mbarara
Uganda 2021-09-08 2024-09-08 5000 • Suspected COVID-19 cases ≥ 18 years of age presenting with symptoms at selected reginal and national referral hospitals in Uganda, will be enrolled for the study. These sites were chosen because they are the regional referral hospitals and register FIND, the global alliance for diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
COMPARISON OF PERFORMANCE OF CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA TEST DEVICE/ TEST REF: ISY-U402 AND CAPILLARY BLOOD VS VENOUS BLOOD ON SYPHILIS ULTRA RAPID TEST STRIP) REF: ISY-U401 USING SD BIOLINE VERSION 3.0 AS A REFERENCE
REFNo: HS1643ES

The objective of this evaluation is to demonstrate the equivalence of capillary (fingerprick) whole blood and venous whole blood on the Syphilis Ultra test device/ Test strip (Whole Blood/Serum/ Plasma) and strip.
2.4 Exploratory Objectives
• To determine the diagnostic accuracy of the Syphilis Ultra test device/ Test (Whole Blood/Serum/ Plasma) and strip.

Kampala, Naguru
Uganda 2021-09-23 2024-09-23 100 3.1 Subject Population Patients attending the Sexually Transmitted Diseases clinic (STD) at China Friendship Regional referral Hospital Uganda will be enrolled for the study. Patients attending this clinic are referrals from other units presenting with s Ministry of Health Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
Evaluation of the performance of the Salmonella Biolineâ„¢ typhi IgG/IgM Fast test in a near-patient testing environment, including evaluation of usability
REFNo: HS1700ES

To evaluate the usability of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in the near-patient environment using a questionnaire based survey. ,To establish the performance of the Biolineâ„¢ Salmonella typhi IgG/IgM Fast test in a near-patient setting compared to the performance in a professional lab (i.e. Central Public Health Laboratory) using venous whole blood samples. ,
pakwach,
Kampala, Kiruddu
Kampala, kisenyi
Uganda 2021-09-29 2024-09-29 80 • Male and female patients above 18 years seeking treatment from selected health units who are able to give consent to the study meeting the selection criteria. ABBOTT KOREA Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
ASSESSMENT OF USABILITY OF THE WONDFO HIV SELF-TEST ONE STEP HIV 1/2 WHOLE BLOOD/SERUM/PLASMA TEST BY UNTRAINED USERS
REFNo: HS1878ES

To evaluate the ability to correctly comprehend key messaging from device packaging and labelling, including the Instructions for Use.,The evaluation of untrained users’ and their interaction with the device in terms of effectiveness and efficiency, i.e. successful / unsuccessful completion and difficulty of the critical steps as per the Instructions for Use,To evaluate the ability of untrained users to obtain an accurate HIV test result using the Wondfo HIV Self-Test.,
Buhweju, Nsika
Wakiso, Central
Bulambuli, Bulambuli Town Council
Mbale, Mbale City
Uganda 2022-08-30 10:24:48 2025-08-30 100 All participants will be > 18 years old of all Sex from the bamasaba region Central Public Health Laboratories Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
Performance evaluation of an improved point-of-care test (dual target) SAMBA HIV-1 qualitative test for early infant diagnosis of HIV-1 infection in resource-poor healthcare settings
REFNo: HS2219ES

To verify the field performance (sensitivity and specificity) of the improved, dual-target SAMBA II HIV-1 Qual Test against routine Cobas Ampliprep/Taqman HIV-1 Qualitative Test Version 2.0 (DBS)- for early diagnosis of HIV-1 in exposed infants and adults. In addition, discrepant results will be analysed using Cepheid Xpert HIV-1 Qual ,
Uganda 2022-05-04 11:32:24 2025-05-04 0 Infants and Adults, between 1.5 months of age and all adults of all tribes Diagnostics for Real World (DRW) Medical and Health Sciences Clinical Trial Non-degree Award
Isaac Ssewanyana
ID: UNCST-2020-R014336
Evaluation of the performance of novel molecular point of care diagnostics for SARS-CoV-2
REFNo: HS2588ES

To assess the ease of use of the molecular POC devices being evaluated using a System Usability Scale (SUS) questionnaire administered to platform’s operators (minimum 3, where possible)., To evaluate the diagnostic accuracy of such platforms in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RTPCR in specific subgroups defined based on disease stage (days since symptoms onset), RTPCR Ct values (as surrogate for viral load). Participant’s vaccination status, previous COVID-19 infection(s) and SARS-CoV-2 genetic variant causing participant’s infection, determined by sequencing of the viral genome, may also be considered as subgroups. , To evaluate the diagnostic accuracy of molecular POC devices in detecting SARS-CoV-2 on respiratory specimens, compared with reference standard RT-PCR (WHO EUL or FDA EUA approved), among COVID-19 symptomatic individuals,
Kampala, Mulago
Kampala, Kiruddu
Kampala, Kawempe
Kampala, Butabika
Uganda 2023-01-18 18:21:06 2026-01-18 200 The study will focus on adults with symptoms compatible with COVID-19 (and/or specimens collected from them) attending healthcare facilities in Uganda. If a participant is screened and enrolled but is not able to provide the specimens required for the study, this participant will be withdrawn. FIND GENEVA Medical and Health Sciences Clinical Trial Non-degree Award
Sharon Pang Sze Lu
ID:
Transform Randomised Controlled Trial in Uganda
REFNo: SS1823ES

To evaluate the impact of the Transform program on the key indicators in values, health and livelihood in Uganda
Hong Kong 2023-08-25 8:07:30 2026-08-25 4800 The study population will include participants aged 18 to 90 years old. Both male and female participants are included in the study. ICM will first choose communities and identify 30 ultra-poor households for its Transform program (administered across control and treatment groups). Eligibility for Transform is determined using poverty assessment via an asset-based scoring and self-reported household income. Historically, there have been an average of 30 households per community. With a target sample size of 160 communities, we will have approximately 4,800 households in the study. ICM targets communities to receive a Transform program based on the proportion of community members living in ultra-poverty (less than USD $0.50/person/day).Participants who are above the threshold using the poverty assessment will be excluded from the study. Households also cannot participate in the study if they have previously received the Transform program, unless the implementation team overrides the score due to specific circumstances that only affect a minority of participants. International Care Ministries Social Science and Humanities Clinical Trial Non-degree Award
Henry Ssenyondo
ID:
Maternal Antibody in Milk After Group B Streptococcus Vaccination in Uganda: MAMA study
REFNo: HS1986ES

General Objective • To determine the concentration of antibody transferred in breastmilk following vaccination with Group B Streptococcal vaccine Specific Objectives • To determine the anti-GBS (anti-Alp1N, Alp2N, AlpCN and RibN) Immunoglobulin A (IgA) concentrations in the colostrum of women following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the total IgA and Immunoglobulin G (IgG) concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgA concentrations in the breastmilk of women at 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgG concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
Kampala, Kawempe Central
Uganda 2022-09-21 21:13:49 2025-09-21 50 Women 18 to 40 years All tribes Makerere University Medical and Health Sciences Clinical Trial 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
Khamisi Musanje
ID: UNCST-2021-R012863
Acceptability, Feasibility and Effectiveness of a Mindfulness based Intervention to Promote Adherence to Antiretroviral Therapy among Adolescents in Kampala.
REFNo: HS1656ES

1. To adapt and explore acceptability of ACT-DNA-v among users (ALWHA) and providers (HCPs).
2. To measure feasibility of the adapted ACT-DNA-v for use with ALWHA.
3. To examine the impact of ACT-DNA-v on reducing proximal psychosocial barriers to medication adherence (depression, anxiety and stigma) among ALWHA.
4. To measure effectiveness of a mindfulness based intervention (ACT-DNA-v) on self-reported adherence among ALWHA in Kampala, and ascertain its impact on viral load reduction via analysis of data from medical records

Kampala, Mutundwe
Kampala, Central
Uganda 2021-10-20 2024-10-20 116 Study will be conducted among older adolescents 14-19 years living with HIV attending care at either Kisenyi or Kitebi health centers. Both male and female will be considered. Behavioral social science research grant Medical and Health Sciences Clinical Trial Degree Award
Stephen Okoboi
ID: UNCST-2019-R001356
Peer Delivered HIV/Syphilis Self-Testing with Assisted Partner Notification Services for Men who Have Sex with Men (MSM) in Uganda
REFNo: HS3021ES

Estimate the cost-effectiveness of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing.,Conduct a pilot randomized trial to pilot test the preliminary effectiveness of peer delivered HIV/syphilis self-tests and partner services versus facility-based testing., Conduct formative research to inform implementation of peer delivered self-tests for HIV and syphilis with partner services for Ugandan MSM. ,
Uganda 2023-10-31 19:59:00 2026-10-31 200 Inclusion criteria: In both arms, peers will recruit network members who are 1) aged 18 years and older, 2) Self-report of anal sexual intercourse at least once in the prior quarter 3) self-identify as MSM, 4) not tested in past 3 months or never tested for HIV or syphilis before; 5) willing to provide informed consent; 6) willing to undergo study procedures National Institute of health 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
Eun Seok Kim
ID:
Cross-sectional prevalence study of schistosomiasis and soil-transmitted helminthiasis with nested open-label randomised controlled study of evaluating the impact of fatty meal co-administration and double-dosing on albendazole effectiveness against hookworm infection among school-aged children in Mayuge district: Implications for Mayuge NTDs Elimination (MANE) Project
REFNo: HS1411ES

Objective 1: To determine the effect of albendazole administration with a fatty meal such as avocado, versus albendazole administration without a fatty meal, on hookworm cure rate and egg reduction rate.

Objective 2: To determine the effectiveness of dual-dose (400mg/day, two consecutive days) versus single-dose (400mg) albendazole treatment regimens on hookworm cure rate and egg reduction rate.

Objective 3: To identify and evaluate environmental, social and cultural variables affecting hookworm infection, and cure rate and egg reduction rate of albendazole against hookworm.

Mayuge, All parish
,
South Korea 2021-08-16 2024-08-16 1650 Age: P4 and P5 grade students (approximately 9-10 years old) Sex: an approximately equal number of both male and female Korea International Cooperation Agency (KOICA) Medical and Health Sciences Clinical Trial Degree Award
Susanne Guidetti Gittel Eleonora
ID: UNCST-2021-R012422
Participation in everyday life - A randomized controlled trial of mobile phone-supported and family-centred rehabilitation after stroke in Uganda
REFNo: HS1528ES

General objective (Overall aim)
To implement and evaluate the effects a mobile phone supported and family-centred rehabilitation intervention F@ce 2.0 aiming to enable performance in daily activities and participation in everyday life among persons who have had a stroke and their family members both in urban (Kampala and its surroundings) and rural (Greater Masaka) areas.

Specific objectives
• To describe the perceived impact of stroke and perceived participation in everyday life in a sample of people with stroke in rural Uganda. (Study 1)
• To evaluate the effects of F@ce in comparison with ordinary rehabilitation among persons with stroke in urban and rural Uganda regarding a) self-efficacy b) perceived performance and participation in everyday activities c) independence in ADL, d) healthcare utilization and e)their families´ perceived participation in everyday activities.(Study 2)
• To explore and describe the experiences of people with stroke and family members of participating in the F@ce (Study 3)
• To evaluate the implementation process of F@ce and to gain knowledge on the mechanisms of impact as well as the contextual factors that might influence the implementation process and its outcome. (Study 4)
• To determine the cost of delivering the F@ce intervention in comparison with the usual rehabilitation (Study 5)

Kampala,
Masaka,
Iganga,
Sweden 2022-01-19 2025-01-19 174 The sample size will accommodate for an attrition rate of 10%, based on our pilot study in Uganda, therefore will require the inclusion of a total of 174 participants with stroke, 15 health professionals and 15 caregivers (family members). The study will The Swedish Research Council 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
Timothy  Muwonge Ronald
ID: UNCST-2020-R014680
Achieving HIV viral suppression in refugee settlements in Uganda with Head StART: a cluster randomized trial evaluating the effectiveness of community ART delivery for people newly diagnosed with HIV
REFNo: HS2935ES

To estimate the programmatic cost and budget impact of implementing the Head StART intervention in refugee settlements in Uganda. ,To assess Head StART implementation across refugee settlement sites to understand the impact of contextual factors on study outcomes. ,To evaluate the effectiveness of “Head StART,” the expansion of community ART delivery to people newly diagnosed with HIV, in achieving HIV viral suppression in refugee settlements in Uganda. ,The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.,
Uganda 2024-01-05 9:11:58 2027-01-05 1200 We will recruit adult persons living with HIV aged 18 and above and accessing care from health care centers in refugee camps in Uganda. National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Thereza Piloya Were
ID: UNCST-2019-R000491
Diabetes in African Youth: Improving Glucose Time-In-Range (DAY Time) Randomized Clinical Trial.
REFNo: HS2129ES

Primary Study Objectives
1. To determine if patient ability to continuously observe plasma glucose levels for 6 months using a flash intermittently scanned CGM improves glucose TIR compared to baseline. The change in glucose TIR while wearing the unblinded CGM will be compared to change in TIR in patients performing 3x/day SMBG (wearing a blinded CGM for endpoint measurement).
2. To perform a cost analysis on flash glucose monitoring compared to 3x/day SMBG, to determine whether this technology is cost effective in the setting of a low-resource nation.
Secondary Objectives: To assess the change-from-baseline impact of unblinded CGM on:
1. Percent time-in-range at 12 months
2. Percent time with glucose 180-250, >250, <70, and <54 mg/dl at 6 and 12 months
3. HbA1c at 6 and 12 months
4. Patient satisfaction and quality of life at 6 and 12 months
5. Glucose variability (coefficient of variation, CV) at 6 and 12 months

Kampala, Mulago
Kampala, Nsambya
Uganda 2022-04-01 2025-04-01 180 randomized in 2 groups : - 90 per group Inclusion Criteria ? Children and youth in Uganda, age 4-26 years at baseline ? T1D of at least 12 months duration at baseline ? Receiving insulin therapy ? Access to a cell phone (nearly ubiquitous in Uganda, even in remote areas) ? Participant/pare United States of America, National Institute of Health 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
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
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