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  
Annet Nanvubya
ID: UNCST-2025-R015525
 Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern version 1.0 16-05-2021.
REFNo: HS1677ES

Primary Objectives
The primary objectives of this study are to determine the following:
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
• To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

Secondary Objectives

The secondary objectives of this study are to evaluate the following:
• Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
• Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)

Exploratory Objectives
The exploratory objectives of this study are to:
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
• Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
• Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
• Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial


 Wakiso, Division A and B
 Uganda 2021-08-20 2024-08-20 14,000 This study will enroll participants who meet one or more of the following criteria: 1) Age > 40, who have at least one comorbidity known to be associated with severe COVID-19, 2) women age 18 years or older who are pregnant, and 3) HIV-1-infected indiv South African Medical Research Council(SAMRC) Cape Town, South Africa Medical and Health Sciences Clinical Trial Non-degree Award
Joshua Muhumuza
ID:
Effect of chewing gum on duration of postoperative ileus following laparotomy for gastroduodenal perforations; a multi centre study.
REFNo: HS1665ES

i. To compare the time taken for post-operative ileus to resolve in the two groups. ii. To compare the duration of hospital stay in the two groups. iii. To determine other factors associated with the duration of post-operative ileus in the study population.
 Kabarole, Central Division
Bushenyi, Central Division
Hoima, Central Division
 Uganda 2022-05-30 17:10:09 2025-05-30 52 participants All adult patients 18 years and above, male and female admitted to the surgical wards of study centre hospitals irrespective of tribe with gastric or duodenal perforations during the study period at will be the study population self sponsored Medical and Health Sciences Clinical Trial Degree Award
Joseph Lutaakome
ID: UNCST-2020-R008323
 An International Multicenter, Randomized, Double-Blind, PlaceboControlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
REFNo: HS1715ES

Primary Objective
Primary objective: Among outpatients with recently diagnosed SARS-CoV-2 infection to compare the safety and efficacy of a single infusion of hIVIG (pooled for the 2 hIVIG

products) versus placebo, each given with SOC, on clinical status after seven days. Two hypotheses will be tested to address this primary objective, which compares the primary endpoint among two study populations: 1) participants where neutralizing MAb was not specified as part of SOC treatment (stratum 1, see Section 6.1 Overall Study Design); and 2) all randomized participants (stratum 1 and stratum 2 combined). hIVIG will be considered superior to placebo if either of the two hypotheses are rejected.
Secondary Objectives and Endpoints
Secondary objectives, including subgroup analyses and safety outcomes, will be addressed for all randomized participants and for those in stratum 1 and 2 separately.
Secondary Endpoints
The clinical status as classified on the ordinal outcome scale will be assessed with a number of additional analyses comparing hIVIG (pooled for the 2 hIVIG products) with placebo, among the overall study population as well as for the key subgroup of those not receiving anti-SARS-CoV-2 monoclonal antibodies as part of SOC (stratum 1), including:
1. All-cause hospitalization or death through 28 days.
2. All-cause mortality through 28 days.
3. Significant disease progression through 28 days, using a time to event analysis with outcome defined by fulfilling criteria for category 4 or 5 on the ordinal scale.
4. Distribution of ordinal scale outcome at Day 4, 14, and 28.
5. The proportion of participants with any disease progression at Day 7, using a sliding dichotomous scale progression defined by a categorization on the ordinal scale that is worse than the status at entry

 Uganda 2021-10-04 2024-10-04 A sample size for this phase 3 trial of 820 participants is planned, which would consist of at least 656 participants in stratum 1. In order to be eligible to participate in this study, a patient must meet all of the following inclusion criteria prior to randomization: i. Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an ii. immunosuppressed condition. The study is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, through their contract organization Leidos. There is a subcontract between the University of Minnesota (the Sponsor) and the MRC CTU at UCL. Medical and Health Sciences Clinical Trial Non-degree Award
Damalie Nalwanga
ID: UNCST-2021-R013217
 SEVERE PNEUMONIA IN CHILDREN: THE ABILITY OF BODY COMPOSITION TO PREDICT SURVIVAL, AND THE EFFECT OF NUTRITIONAL SUPPLEMENTATION ON OUTCOMES
REFNo: HS1719ES

4. To determine the effect of a nutritional intervention (RUTF) on clinical outcomes (post discharge mortality, re-admission, and occurrence of severe acute malnutrition) of children hospitalized for severe pneumonia.,3. To determine the effect of a nutritional intervention (RUTF) on fat and muscle mass in children hospitalised for severe pneumonia.,2. To compare the ability of various muscle and fat mass indices to predict survival in children hospitalised for severe pneumonia.,1. To describe the role of nutritional status on outcomes following hospitalization for severe pneumonia among children.,To describe the relationship between muscle and fat mass and survival, and determine the role of nutritional supplementation on fat and muscle mass, and on treatment outcomes of children hospitalized for severe pneumonia,
 ,
Jinja,
Mbale,
Soroti,
Uganda 2021-10-20 2024-10-20 450 Children aged 6 months to 12 years hospitalized for severe pneumonia. Self Sponsored Medical and Health Sciences Clinical Trial Degree Award
ANGELLA MUSIIMENTA
ID: UNCST-2021-R013297
 My Mobile Wallet: An Intervention to Support Access to Tuberculosis Care and medication Adherence in Rural Uganda
REFNo: HS1688ES

Assess the refined My Mobile Wallet intervention for larger scale feasibility, acceptability, and impact on TB treatment adherence and clinical outcomes. We will randomize 162 newly diagnosed TB patients (1:1:1) to SMS texts + incentives Arm A, SMS texts only B, and control Arm C (standard clinic-based TB care); follow-up will be the 6 month-treatment period. Feasibility and acceptability will be assessed per above. Impact will be based on electronically monitored medication adherence (primary), as well as treatment completion, clinic attendance, cure, and mortality (secondary).,Refine the My Mobile Wallet intervention. We will adapt the intervention to address any feasibility and accessibility issues raised in R21 findings. We will then pilot test the refined version of the intervention in 10 TB patients over two months of treatment to ensure optimal functionality. ,Assess the initial feasibility and acceptability of My Mobile Wallet. Forty patients with newly diagnosed TB will use My Mobile Wallet over their 6-month course of treatment. Feasibility will be assessed by appropriate receipt of the cash transfers and SMS texts, and intervention functionality. Acceptability will be assessed using System Usability Scale [53] and interviews based on the Unified Theory of Acceptance and Use of Technology [54].,Determine the optimal design and develop My Mobile Wallet as an intervention to support TB medication adherence. Through client-centered approaches, we will iteratively conduct focus group discussions with up to 30 TB patients to develop an optimal My Mobile Wallet intervention.,
 Mbarara, Kamukuzi
Mbarara,
Uganda 2021-11-19 2024-11-19 242 TB patients (18 and above years old) living not beyond 60 Kilometers from MRRH who are willing to participate in the study US National Institute of Health (Eunice Kennedy Shriver National Institute Of Child Health & Human Development of the National Institutes of Health) Medical and Health Sciences Clinical Trial Non-degree Award
Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
 Uganda Paediatric and Adolescent HIV Cohort on Antiretroviral Therapy: Study Protocol (UP-ART)
REFNo: HS1699ES

The objectives of this study are to:
1) Describe the characteristics of children and adolescents living with HIV receiving paediatric care in the participating centres and coverage of ART
2) Describe the uptake of new antiretroviral drugs such as DTG across age groups and regions
3) Assess the effectiveness and safety of new antiretroviral drugs such as DTG, including viral suppression, incidence of adverse events, serious adverse events and discontinuation of drug
4) Assess broader clinical outcomes including retention in care, mortality, disease progression, immune response, viral suppression, overall and by age and treatment regimen/treatment history
5) Assess (i) the prevalence of HIV drug resistance among children/adolescents start of treatment and the impact on treatment response, and (ii) among those who experiencing virological failure on DTG to describe the risk of accumulation of drug resistance (see sub-study Section 4).

Hoima, Kahora Division
Lira, Lira
Wakiso, Wakiso
 Uganda 2021-10-14 2024-10-14 3000 All children/adolescents attending HIV care at the participating clinics will be invited to join the study the International AIDS Society, the World Health Organisation, University College London capacity strengthening grant and UNICEF (grant and in-kind support). 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
Emmy Okello
ID: UNCST-2020-R009792
 Remote Ischaemic Conditioning in STEMI patients in sub-Saharan AFRICA: The RIC-AFRICA trial
REFNo: HS1865ES

RIC will reduce the rates of all-cause death and early post-myocardial heart failure by approximately 25% when compared to sham control.,The RIC-AFRICA trial will investigate the effect of RIC in STEMI patients on the rates of all-cause death and early post-MI heart failure (pre-discharge HF and hospitalisation for HF at 30 days post-MI,) when compared to sham control,
 ,
Kampala, MULAGO
 Uganda 2022-02-01 2025-02-01 1500 Participants will be recruited from the Uganda Heart Institute and other nearby state and private hospitals with STEMI care with in Uganda and other collaborating sites in Sub-Saharan countries Mancherje-Potash Foundation, USA Medical and Health Sciences Clinical Trial Non-degree Award
Aisha Nanyiti
ID: UNCST-2021-R013489
 A Randomized Control Trial (RCT) on the Adoption of Liquefied Petroleum Gas (LPG) Cooking Technology among Fast Food (Chapati) Vendors in Uganda
REFNo: SS1017ES

This study seeks to establish the impact of hire purchase schemes and health and safety information on adoption of LPG cookstoves by chapati vendors.

This study will achieve the following specific objectives:
1) The impact of learning from LPG use in grace period before purchase armotisation on adoption of LPG cookstoves by chapati vendors for their businesses and households.
2) The impact of hire purchase on adoption of LPG cookstoves by chapati vendors for their businesses and households.
3) The impact of information on safety and health benefits of LPG on adoption of LPG cookstoves by chapati vendors for their businesses and households.
4) The impact of peer learning from other vendors using LPG cookstoves on adoption of LPG cookstoves by chapati vendors for their businesses and households.
 Kampala,
Uganda 2022-02-10 2025-02-10 210 chapatti vendors; they are mainly males of age range in 18-45 years from all districts of Uganda. Environment for Development Initiative Social Science and Humanities Clinical Trial Non-degree Award
Achilles Katamba
ID: UNCST-2019-R000540
 Human-Centred Design and Communities of Practice to Improve Delivery of Home based Tuberculosis Contact Investigation in Uganda
REFNo: HS1720ES

General Objective: The study aims to assess the effectiveness of an enhanced intervention strategy for implementing TB contact investigation relative to usual care. Specific Objectives: 1.To compare the implementation, effectiveness, and public health impact of TB contact investigation delivered via an enhanced intervention strategy vs. the usual care strategy in a stepped-wedge, cluster-randomized implementation trial. 2.To identify implementation processes and contextual factors that influence the effectiveness of the intervention strategy for TB contact investigation. 3.To compare the costs and epidemiological impact of the intervention and usual care strategies for TB contact investigation.
Masaka, Ndejje
Masaka, Masaka
Butambala, Goombe
Wakiso, Wakiso
Wakiso, Ndejje
Kiboga, Kiboga
Mubende, Kasambya
Mubende, Mubende
Mityana, Mityana
Iganga, Iganga
Bugiri, Bugiri
Jinja, Jinja
Wakiso, Entebbe
Wakiso, Kasangati
Kayunga, Kayunga
Kayunga, Nagalama
 Uganda 2021-09-17 2024-09-17 1764 household and close contacts within approximately 2304 eligible index patient clusters over a 16-month period. Household and close contacts of index patients with active pulmonary TB National Institute of Allergy and Infectious Diseases (NIAID) Medical and Health Sciences Clinical Trial Non-degree Award
JIM ARINAITWE
ID: UNCST-2021-R012572
 Quit4Life: Adapting and Evaluating a Phone-Based Tobacco Uses Cessation Program for People Living with HIV in Uganda and Zambia.
REFNo: HS1762ES

The goal of the study is to adapt and evaluate the efficacy of a phone-based tobacco cessation intervention for PLWH in Uganda and Zambia in five years. The primary objective of the study is to promote smoking cessation among HIV infected persons. Specifically, 1) adapt a standard short message service (SMS) for tobacco cessation program, 2) Nicotine Replacement Therapy, 3) compare the efficacy of our SMS-based program tailored to meet the needs of PLWH (Quit4Life+) to the current standard of care.
Arua, Adumi HCIV, Omugo HCIV and River Oli HCIV
Moroto, Loputuk HCIII, Nadunget HCIII and Tapac HCIII
 Uganda 2021-12-28 2024-12-28 Total Sample size is 800 with 400 from Uganda and 400 from Zambia The study will include males and females of consenting age attending HIV services at Health III, IV, District/Regional Referral Hospitals National Institute of Health Medical and Health Sciences Clinical Trial Non-degree Award
Kamya Moses
ID: UNCST-2020-R014203
 Enhancing immunity to malaria in young children with effective chemoprevention
REFNo: HS1763ES

To compare the incidence of malaria from 4 weeks to 4 years of age among children born to mothers randomized to receive intermittent preventative therapy in pregnancy (IPTp) with monthly sulfadoxine pyrimethamine (SP) alone, monthly DP alone, or both monthly SP+DP.

To compare the incidence of malaria from 2-4 years of age among children randomized to receive IPT in childhood (IPTc) with monthly DP from 8 weeks to 1 year of age vs. monthly DP from 8 weeks to 2 year of age vs. no IPTc.

To compare innate and adaptive effector and regulatory responses between children randomized to different IPT arms.

Busia, Masafu
 Uganda 2021-11-24 2024-11-24 924 HIV-uninfected infants Children both male and female, 4 weeks to 4 years of age, resident of Busia District Division of Microbiology and Infectious Diseases (DMID) Medical and Health Sciences Clinical Trial Non-degree Award
JULIET MWANGA-AMUMPAIRE
ID: UNCST-2022-R009420
 An open-label, multicentre, randomized, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild/moderate cases of COVID-19
REFNo: HS1789ES

Primary objective: to compare the efficacy of alternative treatment strategies versus control on the risk of progression to severe respiratory disease
The secondary objectives are:
 To compare the safety of each study arm to control, up to Day 21 of follow-up
 To compare the rate of hospitalizations due to COVID-19 in each study arm versus control
 To compare the time to hospitalization due to COVID-19 in each study arm versus control
 To compare the rate of hospitalizations for other reason than Covid-19 in each study arm versus control
 To compare the disease-free rate in each study arm versus control
 To compare the death rate in each study arm versus control
 To compare time to worsening of SpO2 < 93in each study arm versus control
 To compare the capacity to prevent severe progression between study arms
 To identify risk factors for severe progression
 To assess efficacy in sub-groups of patients e.g. with pre-existing conditions/co-morbidities, by age group, sex, BMI, timeframe between onset of symptoms and randomization.

 Mbarara, Mbarara Medical Cell
 Uganda 2021-12-07 2024-12-07 175 1. Male or female patients, 2. Adult’s  18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis. 3. COVID-19 confirmed by molecular biology or validated antigenic test Drugs for Neglected Diseases Initiative (DNDi) Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
 ACTIV-2/A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)
REFNo: HS1813ES

1.1 Co-Primary Objectives 1.1.1 Phases II and III: To evaluate safety of the investigational agent. 1.1.2 Phase II: To determine efficacy of the investigational agent to reduce the duration of COVID-19 symptoms through study day 28. 1.1.3 Phase II: To determine the efficacy of the investigational agent to increase the proportion of participants with nasopharyngeal (NP) SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) at study days 3, 7, and 14. 1.1.4 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study day 28. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic. 1.2 Secondary Objectives 1.2.1 Phases II and III: To determine whether the investigational agent reduces a COVID-19 Severity Ranking scale based on COVID-19-associated symptom burden (severity and duration), hospitalization, and death, through study day 28. 1.2.2 Phase II and III: To determine whether the investigational agent reduces the progression of COVID-19-associated symptoms. 1.2.3 Phase II and III: To determine if the investigational agent reduces levels of SARS-CoV-2 RNA in NP swabs. 1.2.4 Phase III: To determine the efficacy of the investigational agent to increase the proportion of participants with NP SARS-CoV-2 RNA below the LLoQ at study day 3. 1.2.5 Phase II: To determine the pharmacokinetics of the investigational agent. 1.2.6 Phase II: To determine efficacy of the investigational agent to obtain pulse oximetry measurement of ≥96% through day 28. 1.2.7 Phase III: To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study week 72. 1.2.8 Phase III: To evaluate if the investigational agent reduces the time to sustained symptom resolution through study day 28.
Wakiso,
Mpigi,
Mukono,
Uganda 2021-11-22 2024-11-22 The phase II evaluation will enroll approximately 110 participants per investigational agent (and 110 on placebo) (this includes all participants enrolled under previous protocol versions, irrespectiv Outpatient adults (≥18 years) with a documented positive SARS-CoV-2 molecular (nucleic acid) or antigen test from a sample collected ≤240 hours (10 days) prior to study entry and with ≤7 days of symptoms of COVID-19 at study entry, plus the presence The National Institute of Allergy and Infectious Diseases, Division of AIDS/NIAID/NIH/DHHS, Rockville, Maryland 20892 USA Medical and Health Sciences Clinical Trial Non-degree Award
Susan Adakun
ID:
Comparing adherence to MDR-TB treatment among patients on self-administered therapy and those on Directly Observed Therapy: Non Inferiority Randomized Controlled Trial
REFNo: HS1796ES

Primary Objectives
1. To determine if adherence to MDR-TB treatment among patients on self-administered therapy (measured by Medication Events Monitoring System (MEMS) technology) is non-inferior to that among patients on Directly Observed Therapy (DOT)
Secondary objectives

1. To determine the correlation between serum MDR-TB drug concentrations and adherence as measured by MEMS technology


2. To compare treatment outcomes between MDR-TB patients on self-administered therapy and DOT

 Kampala, Mulago
Lira,
Mbarara,
Uganda 2021-10-20 2024-10-20 164 Age of study Population: 8 years and above Gender of study population: Both male and female Persons of any and all tribes are eligible for study participation as long as they fit the eligibility criteria Janssen Global Public Health, a division of Janssen Pharmaceutica NV, under grant number 1550786 Medical and Health Sciences Clinical Trial Non-degree Award
SIMON ARUNGA
ID: UNCST-2021-R013498
 Cluster randomised controlled trial of a complex intervention package to reduce blindness from severe microbial keratitis in Uganda.
REFNo: HS1814ES

To determine if a complex intervention package delivered at the Primary Health Centres (PHCs) including early recognition, prompt chlorhexidine 0.2% treatment and rapid referral can result in reduced rates of blindness from severe MK at three months
 Ntungamo, All parishes
Isingiro, All parishes
 Uganda 2022-03-21 2025-03-21 Participants Individuals with corneal abrasions and corneal infection (microbial keratitis) presenting at the cluster primary health centres in these two districts in South Western Uganda will be elig All individuals aged 18 and above, of all sexes in the two districts London School of Hygiene and Tropical Medicine Medical and Health Sciences Clinical Trial Non-degree Award
Francis Ssali
ID: UNCST-2021-R012134
 A Phase 2, Open-label, Single-arm, Multicentre Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to less than 12 years) who are Virologically Suppressed (TMC278HTX2002)
REFNo: HS1815ES


Primary Endpoints
• Area under the plasma concentration-time curve from the time of administration up to 24 hours post-dose of RPV, as derived from the intensive PK assessments.
• Incidence of grade 3/4 AEs, SAEs, HIV-related events (including acquired immune deficiency syndrome [AIDS]-defining illnesses and Stage-3-defining Opportunistic Illnesses in HIV Infection), and AEs leading to discontinuation of study intervention through 24 weeks of study treatment.

Secondary Endpoint
• Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment.
• Change from baseline Movement.
• Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment.
• Treatment adherence, as assessed by the Pediatric European Network for the Treatment of AIDS (PENTA) adherence questionnaire and by study intervention accountability, through 24 and 48 weeks of study treatment.

 Wakiso, Makindye
,
Uganda 2021-11-22 2024-11-22 lower limit is 3 and Upper limit is 10 Participants (boys and girls) aged ≥2 to <12 years with a bodyweight of at least 11 kg Janssen Sciences Ireland Unlimited Company Medical and Health Sciences Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
 BREATHER Plus: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir- based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub-Saharan Africa, Version 2.0, Dated 18-Mar-2020; ISRCTN #: 85058577
REFNo: HS1822ES

Major Objective: A randomized open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir-based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub- Saharan Africa
Specific Objectives
To evaluate an innovative and contemporary ART strategy in HIV-infected adolescents to provide choice for young people facing life-long treatment. Output from this RCT will provide evidence on efficacy, safety and acceptability of a novel treatment approach in HIV-infected adolescents in sub-Saharan Africa
To evaluate the virological efficacy, safety, acceptability and Quality of Life of DTG-based Short-cycle Therapy with weekends off compared with Continuous Therapy with a DTG- based ART regimen
To optimize treatment for HIV-infected adolescents in sub-Saharan Africa

 Kampala, Mulago
Wakiso, Seguku
 Uganda 2021-11-15 2024-11-15 460 HIV-infected, non-pregnant, non-breastfeeding adolescents aged 12 to 19 years of age, virologically-suppressed for at least one year, without any history of treatment failure, on 3-drug combination antiretroviral (ART) consisting of dolutegravir with a 2- University College London (UCL), UK and funded by the European and Developing Countries Clinical Trials Partnership [RIA2017MC- 2005] 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
Robert Kalyesubula
ID:
Effectiveness of a community health worker delivered care intervention for hypertension control in Uganda: a stepped wedge, cluster randomized control trial.
REFNo: HS1917ES

To assess the effectiveness of a CHW-delivered intervention for hypertension control in Uganda.,
 Nakaseke, Kigegge, Bulwadda, Mifunya, Kyamutakasa, Kasambya, Kasagga, North Ward. East Ward. Namilali, Kivule Central Ward
 Uganda 2022-02-10 2025-02-10 900 Hypertensive patients, 18 years and above, attending Nakaseke hospital or Life Care NCD clinics, and residing either in Nakaseke town council, Nakaseke Subcounty or Kasangombe. Else Kroner Fresenius Stiftung Medical and Health Sciences Clinical Trial Non-degree Award
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