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  
Anthony Mugeere Buyinza
ID:
PEAK YOUTH, CLIMATE CHANGE AND THE ROLE OF YOUNG PEOPLE IN SEIZING THEIR FUTURE
REFNo: SS670ES

General Objective:

To explore how climate change in Uganda is affecting young lives and youth livelihoods in the regions of Karamoja and Jinja.

Specific objectives:
(i) To document the diverse lives and livelihood strategies of young people
in rural and urban settings;
(ii) To find out how climate change impacts upon young people's lives and livelihoods;

(iii) To identify youth solutions to the challenges they face.
Uganda 2021-04-21 2024-04-21 Social Science and Humanities Non-degree Award
Elizabeth Ayebare Ombeva
ID: UNCST-2020-R003666
An education package to improve health worker communication with women and families after stillbirth or neonatal death: A feasibility study
REFNo: HS1102ES

1. To pilot an education package and associated resources, including train the trainer/training manuals and audio-visual aids to improve health worker communication in Malawi, Uganda, Zambia and Zimbabwe.
2. For feasibility
a. Explore the acceptability and implementation of the package with facility staff receiving training, trainers and service managers across settings.
b. Explore the acceptability and implementation of the package with undergraduate midwifery students receiving training.
c. Assess uptake and attendance/completion of the package.
d. Explore impacts of the research and education package on practice and clinical services.
3. To prepare for a full-scale evaluation:
a. Define the most appropriate primary and secondary outcomes to assess the effect of the educational package on health workers’ communication and parents’ experiences.
b. Assess the acceptability and burden of data collection for participants.
c. Use data to optimise the design and estimate the sample size for a full-scale trial.
d. Exploration of key resources associated with implementing the educational package will be completed to provide an economic understanding of the intervention and its potential impact.
e. To utilise existing and develop additional networks to identify potential sites for a full-scale trial.
4. To combine the feasibility, acceptability and uptake data to develop a full trial protocol by the end of the study.

Uganda 2021-04-21 2024-04-21 Medical and Health Sciences Non-degree Award
Nixon Niyonzima
ID: UNCST-2020-R014577
SARS-CoV-2 seroconversion: a sero prevalence study among cancer patients and health workers at the Uganda Cancer Institute
REFNo: HS1240ES

3. To describe the temporal trends in the anti- SARS-CoV-2 antibody sero-prevalence among cancer patients at the Uganda Cancer Institute,2. To describe the clinical and demographic characteristics associated with history of exposure to SARS-CoV-2 and severity of COVID-19 disease in cancer patients. ,1. To determine SARS-CoV-2 antibody sero-prevalence in cancer patients attending care at the Uganda Cancer Institute,
Uganda 2021-04-21 2024-04-21 Medical and Health Sciences Non-degree Award
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
A randomized clinical TriaL of early empiric Anti-Mycobacterium tuberculosis therapy for Sepsis in sub-Saharan Africa (ATLAS trial)
REFNo: HS1272ES

The primary hypothesis of this clinical trial protocol is that immediate and sepsis specific dose of anti-TB therapy will result in improved 28-day mortality for study participants admitted to hospital with HIV and sepsis in Tanzania and Uganda compared to standard care alone.

The primary objective is:
1) To conduct a randomized 2x2 factorial clinical trial of 1) immediate initiation of empiric anti-TB therapy plus standard care vs diagnosis dependent anti-TB therapy plus standard care alone and 2) sepsis-specific anti-TB therapy plus standard care vs conventional WHO weight-based anti-TB therapy plus standard care for patients presenting with sepsis to two hospitals in Uganda and Tanzania.
1a) To determine if empiric immediate initiation of anti-TB therapy plus standard care improves 28 day mortality compared to diagnosis dependent anti-TB therapy plus standard care.
1b) To determine if sepsis-specific dose anti-TB therapy plus standard care improves 28 day mortality compared to conventional WHO weight-based anti-TB therapy plus standard care.

The secondary objectives include:
1) To determine if empiric immediate initiation of anti-TB therapy plus standard care improves in-hospital mortality compared to diagnosis dependent anti-TB therapy plus standard care
2) To determine if sepsis-specific dose anti-TB therapy plus standard care improves in hospital mortality compared to conventional WHO weight-based anti-TB therapy plus standard care.
3) To determine if empiric immediate initiation of anti-TB therapy plus standard care improves 6 month mortality compared to diagnosis dependent anti-TB therapy plus standard care
4) To determine if sepsis-specific dose anti-TB therapy plus standard care improves 6 month mortality compared to conventional WHO weight-based anti-TB therapy plus standard care.
5) To determine the safety of increased dose anti-TB therapy for patients with sepsis
6) To determine if early achievement of target serum drug concentrations of isoniazid and rifampin, measured at day-2 of TB treatment, associates with more rapid clinical improvement among patients with confirmed TB.

Uganda 2021-04-21 2024-04-21 Medical and Health Sciences Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
A Survey Assessing Male Reproduction During or After Treatment Containing Pretomanid
REFNo: HS1340ES

To evaluate the paternity status in male participants who have received a pretomanid containing regimen in one of the following TB Alliance clinical trials: STAND, Nix-TB, SimpliciTB or ZeNix.
Uganda 2021-04-21 2024-04-21 Medical and Health Sciences Non-degree Award
Freddy Kitutu Eric
ID: UNCST-2020-R014751
Using community influencer groups to address COVID-19 misinformation and vaccine hesitancy in Buikwe, Uganda
REFNo: HS1140ES

The evaluate the effect of community influencer groups on COVID-19 misinformation and potential COVID-19 vaccine hesitancy.,To form and empower community influencer groups against COVID-19 misinformation and potential COVID-19 vaccine hesitancy ,To explore the effect of COVID-19 misinformation on potential hesitancy towards a future COVID-19 vaccine,To determine the prevalence of potential hesitancy to a future COVID-19 vaccine in Buikwe,To determine the prevalence of COVID-19 misinformation in Buikwe,
Uganda 2021-04-15 2024-04-15 Medical and Health Sciences Non-degree Award
Noleb Mugisha Mugume
ID:
Integrating cervical cancer screening in HIV clinics and assessing the effect of using a modified referral protocol on access to cancer services among HIV-positive women in Uganda
REFNo: HS1219ES

Major objective: To assess the effect of a modified referral protocol on access to cancer services among HIV-positive women with positive cervical cancer screening findings and describe acceptability of integrating cervical cancer screening services in HIV clinics and referring women with positive screening results using the modified referral protocol.

Specific objectives
1. To assess the effect of using a modified referral protocol on access to cancer services among HIV-positive women with positive cervical cancer screening findings.

2. To describe experiences of HIV-positive women and health care providers with implementation of integrated cervical cancer screening services in HIV clinics and referral using a modified referral protocol

3. To describe acceptability of a program that provides integrated cervical cancer screening services in HIV clinics to women presenting for routine HIV care and links those with positive screening findings to cancer care services using a modified referral protocol among health care providers and mangers in the clinics.

Uganda 2021-04-15 2024-04-15 Medical and Health Sciences Degree Award
victoria nakibuuka
ID: UNCST-2020-R014741
Developmental care packages to improve neonatal outcomes – a multidisciplinary approach
REFNo: HS1254ES

To survey current knowledge, practices and attitudes towards developmental care to assess potential barriers and facilitators to implementing and integrating developmental To observe current practice in NICU’s care packages in NICU’s in LMIC

Uganda 2021-04-15 2024-04-15 Medical and Health Sciences Non-degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
D3 (PENTA 21) A randomised non-inferiority trial with nested PK to assess DTG/3TC fixed dose formulations for the maintenance of virological suppression in children with HIV infection aged 2 to <15 years old
REFNo: HS1288ES

The overall aim is to evaluate two-drug therapy with DTG/3TC FDC given once daily in comparison with triple-drug ART in HIV-1 infected children and adolescents who are virologically-suppressed on their ART regimen.

PRIMARY OBJECTIVE
To assess whether DTG/3TC is non-inferior to SOC, consisting of an anchor drug (NNRTI, PI or INSTI) and 2 NRTIs, in terms of virological suppression

HYPOTHESIS
Switching to DTG/3TC will provide non-inferior virological suppression to remaining on SOC over 96 weeks.

SECONDARY OBJECTIVES
ï‚§ To evaluate clinical and laboratory adverse events associated with the trial antiretrovirals
 To evaluate new resistance mutations in participants with virological rebound (confirmed VL≥50 copies/mL)
ï‚§ To assess low level viraemia and virological reservoirs
ï‚§ To evaluate adherence, tolerability, acceptability, sleep and health-related quality of life
ï‚§ To evaluate and model the pharmacokinetics and pharmacodynamics of dispersible and film-coated fixed-dose DTG/3TC formulations in children weighing 6-<40kg using WHO weight band-aligned dosing
ï‚§ To evaluate cost-effectiveness of treatment maintenance with DTG/3TC FDC if DTG/3TC is shown to be non-inferior to SOC

Uganda 2021-04-15 2024-04-15 Medical and Health Sciences Non-degree Award
Godfrey  Siu
ID: UNCST-2021-R005439
The impact of COVID-19 on domestic care work in Uganda
REFNo: SS770ES

1. To determine the burden and patterns of domestic care work during the COVID-19 response phase.
2. To determine the barriers and facilitators of domestic work during the lockdown.
3. To examine the effects of COVID-19 on the social, economic and family relations.
Uganda 2021-04-15 2024-04-15 Social Science and Humanities Non-degree Award
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