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  
Joseph Ngonzi
ID: UNCST-2019-R001579
 OPTIMIZATION, VALIDATION AND ASSESSMENT OF FEASIBILITY AND ACCEPTABILITY OF HPV TESTING USING CODA
REFNo: HS4734ES

To develop and establish a novel rapid multi-modal algorithm (CANOPY) for screening and treatment of cervical cancer integrating multiple (CODA, VIA, ML) screening modalities to improve diagnostic yield. ,To gather design feedback to improve CODA workflow and device design, and refine CODA device, assay, and workflow using this critical feedback provided by Ugandan stakeholders,To evaluate the feasibility and acceptability of CODA in a clinical setting in Uganda based on feedback from clinical, public health, and patient stakeholders,To evaluate HPV testing using CODA in comparison to other (VIA, ML, ATILA System) devices for clinicians and patients engaged in community-based cervical cancer screening. ,To determine the diagnostic accuracy of CODA a clinical setting, using FP rate and comparison with gold-standard HPV tests and cytology,We will optimize, validate and assess the feasibility and acceptability of HPV testing using CODA and develop and validate a multimodal cervical cancer screening algorithm to optimize diagnostic yield (CANOPY).,
 Uganda 2024-12-10 15:49:00 2027-12-10 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Joseph Ngonzi
ID: UNCST-2019-R001579
 PACO Heart Evaluation and Risk Tracking (PACO-HEART)
REFNo: HS5985ES

Main objective: 1. Determine whether women with HIV taking DTG during pregnancy are more likely to experience hypertension, have elevated cardiovascular disease risk factors, and demonstrate vascular dysfunction postpartum.

Sub-Objectives:
1. Prospectively assess postpartum cardiovascular disease risk factors in women with HIV on DTG versus women with HIV on efavirenz (EFV), women who took PrEP in pregnancy, and women without HIV participating in the PACO cohort.
2. Assess vascular function in women with HIV on DTG versus women with HIV on efavirenz (EFV), women who took PrEP in pregnancy, and women without HIV participating in the PACO cohort.
3. Quantify and compare biomarkers of cardiovascular disease in peripheral plasma in women with HIV on DTG versus women with HIV on efavirenz (EFV), women who took PrEP in pregnancy, and women without HIV participating in the PACO cohort.
4. Examine association between placenta pathological features (already measured in PACO cohort participants) and postpartum hypertension, vascular function, and biomarkers of cardiovascular disease


 Uganda 2025-09-17 13:26:00 2028-09-17 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Samson Okello
ID: UNCST-2019-R001580
 Polycyclic aromatic hydrocarbon exposures and dietary risk of Esophageal squamous cell cancer in southwestern Uganda
REFNo: HS37ES

1) To evaluate biomass fuel exposure as an ESCC risk factor by comparing personal carbon monoxide exposure among ESCC patients to that of age and gender matched controls with normal esophageal epithelia. We hypothesize that individuals with ESCC have greater exposure to biomass fuel compared to matched age and gender controls. \r\n\r\n2) To assess food preparation methods and dietary patterns as risk factors for ESCC in southwestern Uganda. We hypothesize that patients with ESCC have unique food preparation methods and consumed foods with high polycyclic aromatic hydrocarbons content compared with age and gender-matched controls with normal esophageal epithelia.\r\n
 Uganda 2017-03-28 2020-03-28 Medical and Health Sciences Non-degree Award
Samson Okello
ID: UNCST-2019-R001580
 Impact of HIV-infection on Geriatric Health among Older-Age People in Southwestern Uganda.
REFNo: HS97ES

Our main objective for this study is to provide data to help answer the following question: How does the prevalence of and risk factors for frailty, decreased physical functioning, visual/auditory impairment, and neurocognitive disorders differ between HIV-infected people versus HIV-uninfected controls in Uganda.
Uganda 2017-11-08 2020-11-08 Medical and Health Sciences Non-degree Award
Samson Okello
ID: UNCST-2019-R001580
 Epidemiology of Coronary Artery Disease among People with HIV in Rural sub-Saharan Africa
REFNo: HS267ES

Our over-arching goals are to demonstrate the extent to which coronary artery disease (CAD) burden may be greater among PLWH in rural Uganda, to discern which risk factors are responsible for this greater burden, and to propose a risk score and promising intervention targets to improve the health of this population. Aim 1: Determine whether CAD is more prevalent and severe among PLWH than HIV-uninfected comparators in rural Uganda. We will complete coronary CT angiography in 600 participants and compare the prevalence and severity of CAD between PLWH and HIV uninfected comparators, before and after adjustment for traditional risk factors Aim 2: Determine the extent to which the association between HIV infection and CAD is modified by sex and region. Within our cohort, we will test for effect modification by sex Aim 3: Identify regional correlates of CAD, and develop a risk prediction score for the presence of CAD among PLWH in rural sub-Saharan Africa. We will collect data on traditional (e.g. age, smoking, diabetes), HIV-specific (e.g. macrophage activation, CD4 count, ART history), and region-specific factors (e.g. biomass exposure, K:T ratio, tuberculosis infection). In Aim 3a we will include traditional, HIV-specific and regional risk factors in models to identify correlates of CAD. In Aim 3b, we will propose a simplified risk score to identify PLWH with CAD.
Uganda 2019-01-29 2022-01-29 Medical and Health Sciences Non-degree Award
Samson Okello
ID: UNCST-2019-R001580
 Experiences and Perspectives of Patients with Hypertension in Mbarara, Uganda
REFNo: HS343ES

To understand the patient experience of hypertension, including diagnosis, understanding of disease, medical adherence, and treatment regimens.

 Uganda 2019-06-06 2022-06-06 Medical and Health Sciences Non-degree Award
Samson Okello
ID: UNCST-2019-R001580
 Cardiovascular risk factor profiles and outcomes in rural Uganda: The Bugoye Hypertension Improvement Project (B-HIP)
REFNo: HS487ES

1. To assess the baseline (at time of enrollment to BHIP) prevalence of various cardiovascular risk factors (obesity, dyslipidemia, and diabetes mellitus) in adults visiting the Bugoye Hypertension Improvement Project.
2. To determine incidence of sustained blood pressure control among persons with hypertension enrolled in BHIP.
3. To assess the costs of hypertension care in a Level III healthcare center in rural Uganda.
 Uganda 2020-02-07 2023-02-07 Medical and Health Sciences Non-degree Award
Samson Okello
ID: UNCST-2019-R001580
 Epidemiology of cardiac dysfunction in sub-Saharan Africa: Heart Failure Registry of HIV-infected and HIV-uninfected persons in Uganda and Zambia
REFNo: HS788ES

1. To describe the clinical characteristics, treatment outcomes, and predictors of all-cause and CV mortality among HIV-infected and HIV-uninfected heart failure adults hospitalized at Mbarara Regional Referral Hospital (Mbarara, Uganda) and University of Zambia Hospital (Lusaka, Zambia).
2. To describe echocardiographic etiology of heart failure among HIV-infected and uninfected adults hospitalized at Mbarara Regional Referral Hospital (Mbarara, Uganda) and University of Zambia Hospital (Lusaka, Zambia).
3. To determine the differences in the serum markers of cardiac fibrosis, cardiac injury, oxidative stress, and hypercoagulability in HIV-infected and HIV-uninfected individuals hospitalized with heart failure at Mbarara Regional Referral Hospital and the University of Zambia Hospital.

 Uganda 2022-03-30 2025-03-30 Medical and Health Sciences Non-degree Award
Samson Okello
ID: UNCST-2019-R001580
 EsophaCap for the Detection of Early Esophageal Carcinoma
REFNo: HS3248ES

Using our POC approach to carry out a diagnostic pilot study of ESCC in Uganda,In order to achieve fully automatic high-speed biomarker assaying, to design a small,light apparatus,In order to achieve a sample-to-answer assay, to implement DNA extraction, bisulfitetreatment, and methylation-specific PCR into a magnetofluidic chip with dried reagents.,Using a sponge-capsule swallowed/tethered collection device, to construct amethylation marker-based strategy to detect ESCC,To evaluate and validate the performance of the combined sponge methylation biomarker strategy in vivo in PRoBE-compliant, among prospective live cohorts od patients with EAC/HGD, ESCC and gastric cancer and controls in Uganda.,
 Uganda 2024-04-26 9:27:48 2027-04-26 Medical and Health Sciences Non-Clinical Trial 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
Elizabeth Ayebare Ombeva
ID: UNCST-2020-R003666
 Translation and validation of the Perinatal Grief Intensity Scale in Kenya and Uganda
REFNo: HS2296ES

1. To perform a culturally sensitive translation and adaptation of the Perinatal Grief Intensity Scale in Kiswahili and Luganda 2. To assess validity and reliability via face, content and construct validity and internal consistency 3. To obtain statistical estimates pertaining to the use of the tool
Uganda 2022-07-13 10:47:29 2025-07-13 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Elizabeth Ayebare Ombeva
ID: UNCST-2020-R003666
 Development of a meta-core outcome set for stillbirth prevention and bereavement care following stillbirth
REFNo: HS2332ES

1) To identify a list of outcomes used in current stillbirth research together with outcomes reported in qualitative literature in an Low and Middle income Country (LMiC) setting relevant to stillbirth. 2) To prioritise outcomes from a health care professional, researcher and parent perspective from an LMic setting. 3) To integrate the outcomes important to all stakeholders in order to ratify a Core Outcome Set.
Uganda 2022-08-25 12:09:48 2025-08-25 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Elizabeth Ayebare Ombeva
ID: UNCST-2020-R003666
 EVALUATING THE EFFECT OF A LOW-COST FOETAL HEART RATE MONITOR AND EDUCATIONAL PACKAGE ON MONITORING INTERVALS AND NEWBORN OUTCOMES IN GULU DISTRICT.
REFNo: HS2868ES

1. To assess the effect of a low-cost Foetal Heart Rate Monitoring device (Moyo) on the Foetal Heart Rate monitoring intervals.
2. To assess the effect of a low-cost FHRM device (Moyo) on detection of fetal heart rate abnormalities
3. To evaluate the effect of the intervention package on immediate newborn outcomes
4. To explore health care providers experiences of Foetal Heart Rate Monitoring before and after the intervention.
Uganda 2023-07-06 17:16:36 2026-07-06 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Elizabeth Ayebare Ombeva
ID: UNCST-2020-R003666
 Development and testing of a tool to assess health workers' clinical confidence to provide perinatal bereavement care in Sub-Saharan Africa (MAKSHSREC-2024-703)
REFNo: HS4959ES

To assess the validity and reliability of the tool across health workers providing care to parents in maternity facilities, including internal consistency and factor structure,
 Uganda 2024-10-21 15:14:14 2027-10-21 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Elizabeth Ayebare Ombeva
ID: UNCST-2020-R003666
 Evaluation of a multicomponent intervention to improve perinatal bereavement support for women and families after stillbirth and neonatal death in Kenya and Uganda: A pragmatic cluster randomised controlled trial.
REFNo: HS3205ES

To explore factors influencing future scale up and sustainability of the intervention ,To explore potential mechanisms of impact of the intervention through understanding womens’, families’, health workers’ and service managers’ views and experiences of the intervention and usual care after stillbirth and neonatal death,To evaluate whether the intervention was implemented as intended during the trial by assessing fidelity, ‘dose’, reach and adaptations made in the study context. ,To assess the cost effectiveness of the intervention from the perspective of the local health systems in Kenya and Uganda ,To assess the mediating effect of perceived social support on intervention impact. ,To assess the impact of the intervention on maternal anxiety, risk of depression and development, diagnosis, and treatment of mental health conditions.,To assess the effectiveness of the co-produced multicomponent interventions in reducing perinatal grief intensity at 8-12 weeks post birth for women who have experienced stillbirth or early neonatal death. ,
 Uganda 2024-01-24 23:23:30 2027-01-24 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Elizabeth Ayebare Ombeva
ID: UNCST-2020-R003666
 Experiences of the CEI members and Researchers working together during Global Health Research on Stillbirth Prevention and Bereavement Care: A grounded theory study in Sub-Saharan Africa and South Asia.
REFNo: SS4036ES

To produce an explanatory theory to underpin a working framework to support relevant research projects and programmes,To understand social processes that guide relationships between CEI members and researchers within a large global health programme,To understand researchers’ experiences of engaging with the CEI group within a large global health programme,To understand CEI group member experiences of contributing to research within a large global health programme,To gain better understanding of facilitators and barriers to effective community engagement through a grounded theory approach,
 Uganda 2025-08-18 13:51:30 2028-08-18 Social Science and Humanities Non-Clinical Trial Non-degree Award
Agnes Kiragga
ID:
Tracing non-rEtained HIV PoSitivE Pregnant Women enrolled in Option B+ and ascertaining their BabIeS outcomes (sTEPWISe)
REFNo: HS35ES

Specific Aim 1: Trace women, initiated ART under option B+ who disengaged from care and assess reasons for disengagement, as well as obtain corrected estimates of retention by evaluating the proportion of mothers who have re-engaged or died.\r\nSpecific Aim 2: Assess and compare HIV transmission rates among infants born to retained and disengaged mothers. \r\nSub-aim 2.1. Perform HIV DNA PCR testing on the infants of disengaged women \r\nSub-aim 2.2 Obtain HIV status data on infants of retained women from existing medical records, or by providing HIV DNA-PCR testing for untested-infants or those whose test was performed within the previous month.\r\nSpecific Aim 3: To measure efavirenz (EFV) levels in the blood collected from all re-engaged and a matched sample of retained women. \r\nSpecific Aim 4: To perform genotypic testing among retained and disengaged women with virologic failure defined as viral load ≥1,000 copies/ml in order to describe mutations that are known to confer drug resistance. \r\n
 Uganda 2017-05-05 2020-05-05 Medical and Health Sciences Non-degree Award
Agnes Kiragga
ID:
Men at Gaming Centers: Point of Care HIV and STI Testing
REFNo: HS70ES

• To test the acceptability and feasibility of same day testing of HIV and syphilis testing, test result notification, prevalence of HIV and syphilis, and proportion linked to care among men attending at gaming/betting centers • To identify the proportion of men involved in other self-reported risky behaviors such as hazardous alcohol intake, illicit drug use, having sex with men and having multiple sexual partners, • To test the diagnostic performance of the ChemBio duo HIV-syphilis point of care test.
Uganda 2017-05-30 2020-05-30 Medical and Health Sciences Non-degree Award
Agnes Kiragga
ID:
Locating disengaged HIV positive women on Option B+ and ascertainment of outcomes among their infants
REFNo: HS175ES

1. To describe the pregnancy outcomes and HIV care status among women (and their exposed infants) who initiate Option B+ 2. To correct 6 week and 18 month estimates of MTCT through tracing of a random sample of HIV positive women who initiated Option B+ during pregnancy and disengaged from care. 3. To identify factors associated with HIV sero-positivity among infants born to women initiated on Option B+. 4. To establish the frequency of Multiclass Resistance among HIV positive infants born to women initiated on Option B+ 5. To estimate the proportion of disengaged women with viral failure and correct estimates of viral suppression (3 rd UN 90 goal) in the facilities.
 Uganda 2018-04-04 2021-04-04 Medical and Health Sciences Non-degree Award
Agnes Kiragga
ID:
A Pilot Test of a Technology-delivered HIV Self-Testing Intervention in Kampala, Uganda
REFNo: HS307ES

1) An established 24-hour call-in center staffed by medical providers who will deliver accurate HIV/STI information, perform pre- and post-test counselling, assist with conducting HIVST and interpreting the HIVST results, and referral and linkage to appropriate post-test prevention and treatment care; and 2) The use of SMS and social media streams – specifically private Facebook and Twitter messages - to “push” theoretically-grounded messages that promote HIVST and provide additional private communication routes between participants and medical provider research staff. The study aims are: Aim 1: Develop HIVST messages and finalize study procedures and materials with input from a Community Advisory Board (CAB), and beta test the intervention with 6 sexually active Ugandan adults (18-49 years old; 50% female). Aim 2: Using a pre-post design, assess the feasibility, acceptability and preliminary impact of the HIVST intervention developed in Aim 1 for Ugandan adults (n=100; 70% 18-24 years old, 30% 25-49 years old; 50% female). Feasibility will be assessed by whether enrollment targets are reached and the proportion of completed 1- and 3-month follow-ups calls. Acceptability items will be gathered at 1- and 3-month assessments. Preliminary impact will be determined by the percentage of participants who perform HIVST in the 3 months after enrollment. Aim 3: Analyze process indicators of the overall use of the HIVST intervention, including the number of HIVST kits requested, the volume of callers requesting HIVST during the study period, the number of persons calling for assistance with self-testing procedures, the number of post-test counseling calls received, and the number of persons linked to follow-up prevention and care services.
Uganda 2019-02-26 2022-02-26 Medical and Health Sciences Non-degree Award
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