Approved Research This page provides a searchable list of all research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology(UNCST).
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Name Title Nationality Approval Date Expiry Date Field of Science/Classification Trial Type Research Type  
Ronald Kiguba
ID: UNCST-2019-R000844
Two-way risk communication mobile application use versus traditional methods of adverse drug reaction reporting in Uganda: a cluster-randomized controlled trial
REFNo: HS1366ES

This study will: i) assess the feasibility of implementing a mobile app for the reporting of ADRs associated with DTG and IPT at selected ART-sites in Uganda; ii) describe the characteristics (causality, seriousness, completeness, unexpectedness, severity, outcome) of the DTG- and IPT-linked ADR-reports submitted to NPC using the mobile app; and, iii) determine if use of the mobile app versus existing methods of ADR-reporting (paper-form and web-form) increases by 25% the number of reported ADRs linked to DTG and IPT use during 2.5 years of follow-up, iv) determine the cost and cost-effectiveness of using the mobile app versus existing methods of ADR-reporting.
Uganda 2021-08-20 2024-08-20 Medical and Health Sciences Clinical Trial Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.
REFNo: HS1669ES

-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
Uganda 2021-08-20 2024-08-20 Medical and Health Sciences Clinical Trial Non-degree Award
Philippa Musoke
ID: UNCST-2021-R013523
ViiV 205858: Open-label access to dolutegravir for HIV-1 infected children and adolescents completing IMPAACT Studies P1093 and P2019 Version 4.0 dated 10 Dec 2020
REFNo: HS1453ES

Primary
• To provide access to age appropriate formulations of dolutegravir (DTG), either as single entity DTG or as fixed dose combination (FDC) abacavir/dolutegravir/lamivudine (ABC/DTG/3TC), in an open-label protocol to eligible participant s who have completed the P1093 or P2019 parent studies.

Secondary

To assess any serious adverse events (SAEs) and any clinical or laboratory adverse events that lead to the discontinuation of IP (DTG or ABC/DTG/3TC FDC).
Uganda 2021-08-20 2024-08-20 Medical and Health Sciences Clinical Trial Non-degree Award
Baker Lukwago
ID: UNCST-2021-R013259
Tracking DISC project activities through integrated surveys in Uganda_Version One May 2021
REFNo: HS1481ES

This research protocol includes the DISC research that will happen from 2021 to 2024 in the DISC project’s focus geographies. The methods include several annual rounds of data collection, with 4 research methodologies: provider surveys, client exit interviews (CEIs), Household Surveys (HHS), and two follow up surveys with the individuals who participate in the CEIs.

Research Objectives
1. To understand exposure to information about self-injectable contraceptives in the DISC sentinel areas.
2. To understand knowledge and attitudes about self-injectable contraceptives among women in DISC sentinel areas.
3. To understand sexual and reproductive health empowerment among women of reproductive age and SI users in DISC sentinel areas.
4. To understand users’ experiences with self-injection training
5. To understand providers’ knowledge and attitudes regarding self-injectable contraceptive service provision.
6. To understand initiation and continuation of self-injection following training.
7. To gain lessons regarding client exit survey methodology for future survey implementation among self-inject clients.
8. To gain learnings regarding follow-up methodologies for future survey implementation among self-inject clients, particularly as relates to continuation measurement.

Uganda 2021-08-20 2024-08-20 Medical and Health Sciences Non-Clinical Trial Non-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

Uganda 2021-08-20 2024-08-20 Medical and Health Sciences Clinical Trial Non-degree Award
Edwin Nuwagira
ID: UNCST-2021-R013488
Improving Pulmonary function after Tuberculosis (IMPACT) at Mbarara Regional Referral Hospital. The incidence, clinical characteristics and factors associated with post-tuberculosis obstructive pulmonary disease at Mbarara Regional Referral Hospital (MRRH)
REFNo: HS1579ES

To determine the incidence, clinical characteristics and factors associated with post-tuberculosis obstructive pulmonary disease at Mbarara Regional Referral Hospital ,
Uganda 2021-08-20 2024-08-20 Medical and Health Sciences Non-Clinical Trial Degree Award
Umaru Ssekabira Byansansa
ID:
Assessing COVID-19 sero-prevalence from routine antenatal care visits in Moyo and Adjumani Districts, Uganda, 2021-2022
REFNo: HS1628ES

The aim of this activity is to determine COVID-19 sero-prevalence from women attending antenatal clinics for their first ANC visit in Moyo and Adjumani Districts from April 2021 to September 2022.
The specific objectives of this sero-prevalence assessment shall be to:
•Measure the sero-prevalence of antibodies to COVID-19 in the population of pregnant women attending first ANC by age group, in order to ascertain the cumulative population immunity
•Monitor trends and detect emerging hotspots of COVID-19 in selected geographic areas

Uganda 2021-08-20 2024-08-20 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Doreen Chemutai
ID:
Pathways, Perceptions and Performance: A comparative Analysis of Women on Open and Reserved Seats in Uganda’s 10th Parliament
REFNo: SS971ES

i. To comparatively analyze the motives of women MPs on the reserved and open seats for seeking parliamentary seats in Uganda’s 10th parliament.
ii. To document the experiences of women members of parliament on the reserved and open seats of their journey to parliamentary seats.
iii. To explain voter’s perceptions of performance of women members of parliament on reserved and open seats.
iv. To evaluate the performance differences of women MPs on the reserved and opens seats of representation and legislation

Uganda 2021-08-20 2024-08-20 Social Science and Humanities Non-Clinical Trial Degree Award
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


Uganda 2021-08-20 2024-08-20 Medical and Health Sciences Clinical Trial Non-degree Award
Judith Kobusinge
ID:
Effect of selected soil moisture conservation practices on water budgeting in Robusta coffee in Uganda
REFNo: A117ES

1) To predict the effect of soil moisture on Robusta coffee production and productivity in Uganda. 2) To estimate the water use efficiency (WUE) of Robusta coffee at various phenological stages under Albizia coriaria and Open sun 3) To determine the effect of selected soil moisture conservation practices on soil-water relations in Robusta coffee agro-systems.
Uganda 2021-08-19 2024-08-19 Agricultural Sciences Non-Clinical Trial Degree Award
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