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  
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A behavioural Science Research to Determine Factors that Facilitate Future Uptake of HIV Prevention Products and Multi-Purpose Prevention Technologies to Prevent HIV and Unwanted Pregnancy in Sub-Saharan Africa Universally Accessible HIV Prevention Technologies for African Girls and Young Women through Knowledge Applied from Behavioural Economics (UPTAKE)
REFNo: HS1540ES

Multi-purpose Prevention Technologies (MPTs) to prevent HIV and unwanted pregnancy in Sub-Saharan Africa

i. To understand facilitators of and barriers to uptake and retention of injectable and implantable long acting pre-exposure prophylaxis (LA-PrEP) and MPT to inform product development, using formative behavioural research methods
ii. To design interventions to impact the uptake of new biomedical HIV prevention products, as part of a suite of self-care and self-screening products for sexual and reproductive health, using quantitative behavioural research methods
iii. To test the effectiveness of the alternate design/interventions and strategies, using marketed LA contraceptive products as proxies for LA HIV prevention products in development
iv. To estimate the cost of retention interventions and the cost effectiveness of products and delivery methods among adolescent girls and young women (AGYW) and female sex workers (FSWs) for prevention of pregnancy and/or HIV, using modelling

 Kampala, NOT APPLICABLE
 Uganda 2021-08-31 2024-08-31 1190 Adolescent Girls and Young Women (AGYW) aged 15 to 24 years and Female Sex Workers (FSW) aged 15 to 45 years, Health Care Providers (HCP), and Policy Makers (PM) in Kampala, Uganda and Nairobi, Kenya. Study Size and duration: Stage 1: 30 AGYW, 30 FSW, 10 International AIDS Vaccine Initiative, The Address, 11th Floor, Muthangari Drive, Nairobi, Kenya; T:+254.719.043.000 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
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
Deo Wabwire Ogema
ID: UNCST-2021-R013932
 COVPN 3008: Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Version 1.0 16 May 2021
REFNo: HS1659ES

The primary objectives are:
•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 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)
The exploratory objectives are to evaluate:
•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

 Kampala, Mulago 1
 Uganda 2021-08-20 2024-08-20 14,000 across all sites, about 500 from Uganda The study population will include 1.Adults aged 40 years or more with at least one co-morbid factor associated with severe COVID 19 2.People living with HIV who are 18 years and above Pregnant women aged 18 years and above South African Medical Research Council (SAMRC) Medical and Health Sciences Clinical Trial Non-degree Award
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
 Determination of Adequate TUberculosis Regimen in Adults and adolescents hospitalised with HIV-associated severe immune suppression (Acronym: DATURA).
REFNo: HS1487ES

Primary objective: To estimate the impact of an intensified initial phase of tuberculosis (TB) treatment on mortality at 48 weeks among HIV-infected adults and adolescents hospitalised for TB with CD4 ≤ 100 cells/μL in comparison with the standard TB regimen. Secondary objectives: To estimate the impact of an intensified initial phase of TB treatment, in comparison with the standard TB regimen, on: ¥ Mortality at weeks 8 and 24 ¥ Adverse events, including: - All grade 3-4 events - Selected grade 2 events of interest - Drug-related adverse events - AIDS defining illnesses - Paradoxical TB-associated immune reconstitution inflammatory syndrome (IRIS) ¥ TB treatment success ¥ TB recurrence ¥ Antiretroviral treatment (ART) response in terms of virological success and immunological response ¥ Adherence to TB treatment and ART ¥ Peak plasma concentrations of rifampicin and isoniazid (and its N-acetyl-metabolite) at day 3, day 7 and week. ¥ Plasma concentrations of efavirenz and dolutegravir at week 4 (i.e. 2 weeks after the onset of ART)
Mbarara, Mbarara
 Uganda 2021-07-16 2024-07-16 1330 15-85years, All sexes, all tribes, ethnicities and religions Inserm-ANRS French National Institute for Health and Medical Research (Inserm) ANRS Infectious Emerging Diseases – Autonomous Agency of Inserm (ANRS) Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano Kaleebu
ID: UNCST-2021-R013577
 A clinical trial to assess the safety and immunogenicity of LNP-nCOV saRNA-02, a self-amplifying ribonucleic acid (saRNA) vaccine encoding the S glycoprotein of SARS-CoV-2, the causative agent of COVID-19, in SARS-CoV-2 seronegative and seropositive Uganda population
REFNo: HS1641ES

Primary Objective:

• To compare the safety and immune responses for SARS-CoV-2 seronegative and seropositive individuals from two immunisations with LNP-nCOV saRNA-02 administered IM 4 weeks apart at one dose level in 42 participants age 18-45 years.

Exploratory Objectives:
• To characterise the humoral and cellular immune responses to LNP-nCOV saRNA-02 administered at one dose given at 0 weeks and 4 weeks for individuals seronegative and seropositive for SARS-CoV-2 antibodies
• To characterise the profile of class and sub-class of antibody responses
• To characterize infection induced immune responses in participants with naturally acquired infection who are also exposed to the vaccine

 Masaka, Butego
 Uganda 2021-09-08 2024-09-08 42 The study will be conducted in healthy young adults as these individuals generate the most robust responses (18-45 years). Both male and female participants will be included and the trial site will attempt to keep an equal proportion, although the priorit The study is sponsored by Imperial College London, funded by the United Kingdom Engineering and Physical Sciences Research Council. Medical and Health Sciences Clinical Trial Non-degree Award
Violet Korutaro
ID: UNCST-2019-R000618
 IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Short title: ‘MOCHA’ (More Options for Children and Adolescents), DAIDS # 30070, IND # 138,754
REFNo: HS1512ES

To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents,To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents by evaluating: Safety and multiple dose PK of oral CAB through Week 4, Safety and multiple dose PK of CAB LA through Week 16, and to confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16,To confirm the dose and evaluate the safety, tolerability, acceptability, and pharmacokinetics (PK) of oral cabotegravir (CAB), long-acting injectable cabotegravir (CAB LA), and long-acting injectable rilpivirine (RPV LA) in virologically suppressed HIV‐1 infected children and adolescents aged 12 to <18 years.,
 Kampala, Kisenyi
Kampala, Mulago
Kampala, Kawaala
Kampala, Naguru
Kampala, Kitebi
 Uganda 2021-08-16 2024-08-16 155 This study will be conducted in Kampala among HIV‐1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral. These potential partic National Institute of Allergy and Infectious Diseases Medical and Health Sciences Clinical Trial Non-degree Award
Eleanor Namusoke Magongo
ID: UNCST-2021-R013199
 Transitioning children to Optimal Regimens of Paediatric Dolutegravir (TORPEDO) in Uganda
REFNo: HS1596ES

the primary objective for the study is to assess patients’/ caregivers’ preference for a paediatric DTG regimen over their previous regimen, when transitioned from another regimen.

 Hoima, Kahora Division
Wakiso, Wkiso
Lira, Lira city
Buikwe, Buikwe
Mayuge, Mayuge
Kampala, Kampala
 Uganda 2021-09-22 2024-09-22 approximately 4,000 children and adolescents 0-19 years Clinton Health Access Initiative 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
Jerome  Kabakyenga Kahuma
ID: UNCST-2021-R013729
 The A-Lite vein locator: “a non-invasive assistive medical device designed to improve vein visibility among patients requiring intravenous therapy.”
REFNo: HS1547ES

Main Objective
1. To assess the efficacy, safety and impact of using an assistive medical device to aid vein visibility among patients requiring intravenous therapy.

Specific Objectives
1. To assess the safety and efficacy of the A-Lite vein locator among 10 adults in Uganda.

2. To investigate non-inferiority by assessing the performance of the A-Lite vein locator with respect to the existing standard of care among 48 adolescents in Uganda.

3. To determine the effectiveness of using the A-Lite vein locator for improving vein visibility among 156 children requiring intravenous cannulation in Uganda.
 Kalungu, Bugonzi
Lira, Junior Quarters
Mbarara, Rwebishekye
Isingiro, Kashojwa
 Uganda 2021-11-19 2024-11-19 214 Ages eligible for the study: 1 up to 30 years Sexes eligible for the study: All International Development Research Centre (IDRC) – Canada and the Government of Uganda Medical and Health Sciences Clinical Trial Non-degree Award
Jonathan Kayondo
ID: UNCST-2021-R008325
 Multi-Centre, Prospective, Evaluation for Matrix equivalence of capillary whole blood finger-stick and fresh and frozen venous whole blood with the NxTekâ„¢ Malaria Pf Plus Rapid Test Device and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test Device for the Detection of Plasmodium Infections in Patients with Symptoms Suggestive of Malaria within the Lab and its intended use environment for CE IVDR.
REFNo: HS1587ES

This trial is part of the R&D Verification and Validation studies, to provide clinical matrix equivalence evaluation to support the conformity assessment procedure for the use of fingerstick and venous whole blood samples with Abbott’s NxTek™ Malaria Pf Plus and NxTek™ Malaria Pf/Pv Plus Rapid Test Devices, as performed by professional users, in accordance with WHO PQ TSS-3, WHO PQ Dossier, EU 2017/7461.

Primary Objective: Matrix Equivalence
To assess the matrix equivalence of:
a. Fresh CWBFS and Fresh VWB
b. Frozen VWB and Fresh VWB
when used with the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus by laboratory professionals (from hereon referred to as Lab operators) in a laboratory environment to support CE IVDR certification.

The test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using a VWB sample, will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using CWBFS sample from the same participant. In summary: Fresh CWBFS vs. Fresh VWB*. Likewise, the test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using VWB samples that have been exposed to 1x Freeze/Thaw cycle will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using fresh VWB samples from the same participant. In summary: Frozen VWB vs. Fresh VWB*

*indicates: Where Fresh VWB will be the comparator sample type.

The data obtained will be used in the application for CE IVDR certification and WHO PQ. Paired CWBFS and VWB samples will be taken from the same individuals for testing on both NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus RDTs.

Secondary Objective: Intended Users within the Intended Use Environment
Malaria RDTs are used outside of the laboratory for near patient testing (NPT)* by non laboratory healthcare workers with limited training. Thus the secondary objective of this study is to assess the perfromance of the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus results when used in its intended environment (NPT setting) by intended users (non laboratory healthcare workers with limited training) using CWBFS as the sample type.*see NPT definition Section 4.2-4.3 of protocol (or below sections on trial operator types and trial envitronment types).

 Kanungu, Market Cell
Wakiso, Maganjo
Wakiso, Central Ward
 Uganda 2021-08-16 2024-08-16 Section 5.2 of Protocol: Two arms- each kit minimum 90 Pf Positives, 26 Pv Positives, 116 Negatives All comers, febrile symptomatic patients of both sexes aged 15 years and above suspected of having malaria and seeking standard medical care at the sites. Abbott Diagnostics Korea Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Christine  Wiltshire Sekaggya
ID: UNCST-2019-R000578
 Clinical Predictors of 3-Months Isoniazid Rifapentine (3HP)- Related Adverse Drug Reactions (ADR) During Tuberculosis Preventive Therapy (PAnDoRA-3HP study)
REFNo: HS1582ES

Primary Objectives
1.To describe the safety profile of 3HP among people receiving tuberculosis preventive therapy.
2.To describe the effect of adverse drug reactions on tuberculosis preventive therapy completion rates
Secondary Objective
1.To describe the pharmacokinetic and pharmacogenomic determinants of ADRs among people receiving tuberculosis preventive therapy in Uganda
2.To determine the efficacy of 3HP when used for tuberculosis preventive therapy.

 Kampala, Mulago III
Kampala, Kisenyi
Kampala, Kasubi
Kampala, Nakawa I
Jinja, Magwa
Mubende, Mubende Town Council
 Uganda 2021-10-04 2024-10-04 614 Patients will be included in the study if they meet the following inclusion criteria: 1. Individuals of any age who have been initiated on TPT using the isoniazid/rifapentine regimen according to standard of care 2. Both PLWHIV and HIV-uninfected indivi National Institution of Health Medical and Health Sciences Clinical Trial Non-degree Award
ELIZABETH NALINTYA
ID: UNCST-2021-R012882
 Long title: A community-based Phase III, cluster randomized trial of point-of-care CD4 testing and enhanced screening and prophylaxis in advanced HIV disease Short title: An enhanced package of care to reduce mortality in advanced HIV disease
REFNo: HS1605ES

Primary Objectives:
1. To assess 24-week survival with retention in care in persons with advanced HIV disease (CD4<200 cells/µL) with point-of-care CD4 testing compared to standard flow cytometry
2. To assess 24-week survival with retention in care with an enhanced diagnostic OI screening and prophylaxis strategy compared to standard WHO package of care in persons with advanced HIV disease
Secondary Objectives:
1. To determine incidence of OIs
2. To measure adverse events with enhanced prophylaxis regimens
3. To assess tolerability and adherence of enhanced prophylaxis regimens
4. To determine incidence and cause of hospitalization for persons with advanced HIV disease
5. To determine cause of death for persons with advanced HIV disease
6. To determine HIV outcomes of viral suppression in persons with advanced HIV disease.
7. Measure cost, cost-effectiveness, and budgetary impact of the CD4 testing strategies, and OI screening and prophylaxis strategies.

 Kampala,
Wakiso,
Uganda 2021-09-21 2024-09-21 2400 • Age >18 years • CD4<200 cells/µL • Ability and willingness to give informed consent for the enhanced package of care arm. INFECTIOUS DISEASES INSTITUTE Medical and Health Sciences Clinical Trial Non-degree Award
Rhoda Wanyenze
ID: UNCST-2021-R013352
 PILOT OF A NETWORK-DRIVEN, ADVOCACY INTERVENTION TO PROMOTE CERVICAL CANCER SCREENING IN UGANDA (PHASE 3)
REFNo: HS1633ES

The proposed intervention development study seeks to improve cervical cancer screening in Uganda by engaging and training local public health researchers and program implementers, and empowering women living with cervical cancer risk (WLCCR), defined as women who have ever received CC screening procedures, to advocate for CC screening and early treatment among women in their social networks.
 Namayingo, Buyinja
 Uganda 2021-08-16 2024-08-16 40 index participants; 120 social network members This study represents phase 3 of the study that was earlier registered with UNCST. During this phase, we will aim to enroll women living with cervical cancer risk (hereafter referred to as the 'index participants'), defined as women who have ever been scr Glenn Wagner (RAND Corporation, USA) Medical and Health Sciences Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
 Field Performance Evaluation of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in Uganda
REFNo: HS1606ES

Main objective
To evaluate the field performance of the m-PIMATM HIV-1/2 VL plasma VL in identifying virological failure (VF) in adults on ART. The performance will be compared to standard PCR assays used at UNHLs and UVRI.
2.3.2 Primary objectives
I). To evaluate the diagnostic accuracy using the sensitivity, specificity, NPV, PPV, FPR and FNR of the m-PIMAâ„¢ HIV-1/2 VL plasma assay in comparison to a reference assay of HIV-1 RNA PCR in identifying HIV-VF at the WHO recommended threshold of 1000 copies/ml for HIV-1 infected.
II). To determine the operational characteristics of the m-PIMAâ„¢ HIV-1/2 VL plasma assay, such as ease of-use of the assay using the standardized system usability scale (SUS) by laboratory and no laboratory personnel
III). To determine changes in turn-around time and ease of clinic workflow integration.
IV).To determine acceptability of the m-PIMAâ„¢ HIV-1/2 VL plasma assay by the study participants

 Kampala, Kampala
Buikwe, Buikwe
Kayunga, Kayunga
Mpigi, Mpigi Town Council
 Uganda 2021-08-11 2024-08-11 403 participants -Adult ART patients who are ≥18 years old on ART for ≥ 6 months will be approached for study participation. Historical controls will be used to compare the time to initiation of intensive adherence counselling (IAC) between the m-PIMA and the standard - Abott Diagnostics Medical and Health Sciences Clinical Trial Non-degree Award
Hannah Kibuuka
ID: UNCST-2020-R014355
 A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older
REFNo: HS1638ES

1. To assess, in participants who are SARS-CoV-2 naïve, the
clinical efficacy of the CoV2 preS dTM-AS03 vaccines for
the prevention of symptomatic COVID-19 occurring ≥ 14
days after the second injection.

2. To assess the safety of the CoV2 preS dTM-AS03 vaccines
compared to placebo throughout the study.
 Kampala,
Wakiso,
Mukono,
Uganda 2021-08-10 2024-08-10 800 Adults 18 years of age and older Sanofi Pasteur Inc. Medical and Health Sciences Clinical Trial Non-degree Award
BRENDA GATI MIREMBE
ID: UNCST-2021-R013390
 A Phase 3, Randomized, Active Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Women at High Risk for HIV 1 Infection.
REFNo: HS1631ES

Primary Objectives:
1. To evaluate the efficacy of oral ISL QM compared to FTC/TDF QD for the
prevention of HIV-1 infection as assessed by the incidence rate per year of confirmed
HIV-1 infection.

2. To evaluate the safety and tolerability of oral ISL QM compared to oral FTC/TDF QD as assessed by review of the accumulated safety data

Secondary Objective
1. To evaluate the efficacy of oral ISL QM in reducing the incidence per year of HIV-1
infection relative to the background rate.

 Kampala,
Wakiso,
Mukono,
Mpigi,
Nakaseke,
Luweero,
Buikwe,
Jinja,
Gomba,
Butambala,
Kayunga,
Uganda 2021-08-27 2024-08-27 Approximately 4,500 participants will be randomized (stratified by site and age) in a 1:1 ratio to receive either ISL or FTC/TDF for the duration of the study. Approximately 50% of the global study po Cisgender female participants aged 16 to 45 years of age who are at high risk of acquiring HIV-1 infection. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Medical and Health Sciences Clinical Trial Non-degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
 CoVPN 3008- UBUNTU Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. Version 1.0, dated 16 May 2021. DAIDS Document ID # 38838.
REFNo: HS1642ES

Primary Objectives
The primary objectives of this study are to determine the following:
1. 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
2. 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
3. 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:
1. 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
2. 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
3. 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
4. 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
5. Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
6. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status

Exploratory Objectives
The exploratory objectives of this study are to evaluate the following:
1. 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
2. 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
3. VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
4. 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
5. Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
6. Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial

 Kampala, Mulago
Kampala, Kawaala
Kampala, Wankuluku
Kampala, Kisenyi
Kampala, Kisugu
Kampala, Kisugu
 Uganda 2021-08-24 2024-08-24 125 This study will be conducted in regions and populations where new more resistant variants of SARS-CoV-2 are highly prevalent. Prevalence of the new variants is known to result in reinfections, suggesting that a prior infection with the SARS-CoV-2 ancestra The study is sponsored by the South African Medical Research Council (SAMRC) and funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institute of Health (NlH) of the United States of America. Medical and Health Sciences Clinical Trial Non-degree Award
Namulema Edith
ID:
Effectiveness of the ‘LeVe CPAP’ against the standard AIRVO CPAP among Covid-19 patients with Acute Hypoxemic Respiratory Failure at Mengo Hospital Kampala Uganda: A Cross-Over Randomised Trial.
REFNo: HS1647ES

The main objective of the trial is to compare the clinical effectiveness of the LeVe CPAP device to the standard AIRVO CPAP in the delivery and maintaining continuous positive airway pressures among patients diagnosed with AHRF at Mengo Hospital Uganda.
 Kampala, mengo
 Uganda 2021-10-28 2024-10-28 40 Male and Female Adult patients with evidence of acute hypoxaemic respiratory failure admitted at the CTU. Any Tribe. Leeds Teaching Hospital National Health Service Trust in the UK Medical and Health Sciences Clinical Trial Non-degree Award
Fred Ssewamala
ID: UNCST-2020-R014060
 Youth Health SMS: Using mobile technology to prevent HIV and related Youth Health problems: Sexual health, Mental health, and Substance use in southwest Uganda
REFNo: SS969ES

This study will result in the development of one of the first mobile phone-based interventions for Adolescents and Young Adults (AYA) in East Africa that begins to address the co-morbid HIV risk factors of sexual health, mental health, and alcohol use. AYA is a developmental period associated with the increased importance of peers, increased technology use, increased mobility, initiation of sex, emergence of mental health disorders (if at risk), and initiation of alcohol use. Consequently, AYA is a critical time for preventive interventions. Poor mental health and alcohol abuse are associated with increased risk for HIV infection. Thus, the proposed research will attempt to address these areas concurrently.

The proposed research will evaluate if adapting and updating the existing free and nationally available text message and interactive voice recognition (IVR) service included in *161 that was initially developed by FHI 360. Our work will test and tailor messages for AYA to disseminate pre-exposure prophylaxis (PrEP) information and pilot specific mental health and hazardous alcohol use screens. Symptomatic AYA will be referred to behavioral health counselors for further assessment and treatment as needed. AYA today rely heavily on mobile phones for information and services, thus we believe the proposed intervention could be applied and adapted across the region, and potentially in other under-resourced settings.

We will conduct formative research to evaluate and adapt an existing text-message and interactive voice recognition (IVR) platform. We will then pilot the new menus and examine if using this platform promotes HIV prevention (pre-exposure prophylaxis (PrEP), HIV testing, safer sexual behaviors) and increases mental health and alcohol use screening and linkage to counselors as needed for adolescents and young adults (AYA) in a rural Ugandan region with high HIV seroprevalence and limited resources.

2. State the study objective(s) and research question(s)
Aim 1: To adapt an evidence-based mobile phone-delivered sexual health program, to include PrEP information and deliver mental health and alcohol use assessments with the goal of increasing screening and referral, as well as linkage to counselors for AYA at HIV risk.

Aim 2: Evaluate through a pilot RCT (N=126 AYA, 15-19 years) intervention (a) acceptability and feasibility, and (b) impact on uptake of HIV prevention strategies, as well as screening and linkage to mental health and alcohol use school-based counselors.

 Masaka, Kimaanya
Kalungu, Kabukunge
 Uganda 2021-10-12 2024-10-12 164 There will be two phases to the study. The first will be approximately three months and include 24 male and female AYA (15-19) years. The second phase will include 140 male and female (15-19 years). National Institute of Mental Health (NIMH) Social Science and Humanities Clinical Trial Non-degree Award
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