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  
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19
REFNo: HS2642ES

The main intent of the study is to evaluate the efficacy of S-217622 vs. placebo. The study will be conducted in the setting of the locally available standard-of-care COVID-19 treatment. High-risk and low-risk participants will be analyzed together for the primary analysis and separately for secondary analyses. The following primary, secondary, and exploratory objectives will be addressed in the modified intent-to-treat (mITT) population, except for the safety analyses, which will be analyzed in the Safety population, and pharmacokinetic (PK) analyses, which will be analyzed in the PK population.
Uganda 2023-02-06 17:17:04 2026-02-06 Medical and Health Sciences Clinical Trial Non-degree Award
Afiz Kibuuka Kibuuka
ID: UNCST-2021-R012755
A phase III, Multicenter, Randomized, Placebo Controlled, Double blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5365ES

To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52 week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the Screeening visit
To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period: • VOCs that are HCP-managed at a health care facility • VOCs that are HCP-managed via remote consultation • VOCs that are self-managed without recommendations from HCP during the event • VOCs that are HCP-managed via remote consultation or self-managed without recommendations from HCP during the event
To evaluate the time to first VOC that is HCP managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
Uganda 2024-12-23 11:34:49 2027-12-23 Medical and Health Sciences Clinical Trial Non-degree Award
Dickens Akena Howard
ID: UNCST-2019-R000179
Neuropsychiatric Genetics of African Populations - Psychosis (NeuroGAP-P)
REFNo: HS14ES

i) Expand knowledge of the genetic architecture of schizophrenia and bipolar disorder in Africa through large-scale sample collection, analysis and follow-up.\r\n\r\nii) Increase understanding of the genetics of African populations\r\n\r\niii) Enhance neuropsychiatric genetic research capacity in Africa through the training of scientists and support the development of locally led research programs\r\n
Uganda 2016-11-01 2019-11-01 Medical and Health Sciences Non-degree Award
Dickens Akena Howard
ID: UNCST-2019-R000179
Developing a peer support model for depression care in patients with diabetes mellitus, and testing it’s efficacy on patient outcomes; a randomized control trial.
REFNo: HS20ES

The main study objective will be developing a peer support model of depression care for patients with DM and testing its efficacy on clinical outcomes
Uganda 2017-02-24 2020-02-24 Medical and Health Sciences Non-degree Award
Dickens Akena Howard
ID: UNCST-2019-R000179
The effect of psycho-education on clinical outcomes among patients with a first episode psychosis in central Uganda - A pilot randomized control trial
REFNo: HS1026ES

The study objectives are to (a) Conduct formative work and develop a manual for delivering psycho-education messages by Village Health Team (VHTs) members to individuals with first episode psychosis (FEP) and their families in central Uganda. (b) Examine the efficacy of psycho-education on symptom severity, stigma and retention in care. (c) Document feasibility and acceptability of implementing this intervention as well as barriers to its implementation
Uganda 2021-03-12 2024-03-12 Medical and Health Sciences Non-degree Award
Dickens Akena Howard
ID: UNCST-2019-R000179
Integration of mental health care in communities affected by the COVID-19 pandemic - A cluster randomized trial of 24 villages in central Uganda
REFNo: HS1009ES

Our objectives will include: (a) Documenting MHL, PD, MDD, GAD, PTSD and SUD levels in the study population, (b) Determining the effectiveness of a psycho-education intervention delivered by village health team (VHT) members on study outcomes, (c) Determining the cost and cost effectiveness of delivering a psycho-education intervention, and (d) linking individuals in need of mental health care with the MOH psychosocial teams.
Uganda 2020-12-15 2023-12-15 Medical and Health Sciences Non-degree Award
Dickens Akena Howard
ID: UNCST-2019-R000179
Genetics of Post-Traumatic Stress Disorders (PTSD) in African Ancestry Populations
REFNo: HS3156ES

(i) Expand knowledge of the genetic architecture of PTSD in the African continent through large-scale sample collection and analysis, (ii) Increase understanding of the high burden of trauma and PTSD faced by African populations and (iii) Enhance neuropsychiatric genetic research capacity in Uganda through the training of scientists and support the development of locally led research programs


Uganda 2023-09-19 8:11:56 2026-09-19 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Dickens Akena Howard
ID: UNCST-2019-R000179
NeuroGAP follow up study on Anhedonia, OCD, Discrimination, and Suicidality
REFNo: HS3158ES

1.Characterize anhedonia, OCD, stigma, and suicidality using diagnoses and item-level data collected across the NeuroGAP samples. 2. Generate high-quality harmonized phenotype data across psychiatric conditions in the study population, and 3. Conduct genetic analyses aimed at identifying genes linked to anhedonia, OCD, stigma and suicidality in the NeuroGAP-Psychosis the Ugandan populations, develop population-valid polygenic risk scores and contribute data to global meta-analyses aimed at identifying genes for these psychiatric conditions in African and trans-ethnic populations.
Uganda 2023-09-08 14:00:44 2026-09-08 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Dickens Akena Howard
ID: UNCST-2019-R000179
Cultural adaptation of the coordinated specialty care (NAVIGATE) in Uganda
REFNo: HS6280ES

Study objective: The study objectives will include

Objective 1. Culturally adapting and locally contextualizing NAVIGATE into a CSC manual (NAVIGATE-UG) for use in Uganda.

Objective 2: Documenting the feasibility and acceptability of using the adapted NAVIGATE-UG manual

Uganda 2025-08-18 13:24:11 2028-08-18 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Dickens Akena Howard
ID: UNCST-2019-R000179
Neuropsychiatric Genetics of African Populations - Psychosis, II NeuroGAP-Psychosis II
REFNo: HS6452ES

i). Expand knowledge of the genetic architecture of schizophrenia and bipolar disorder in the African continent
through large-scale sample collection and analysis in Uganda
ii) Increase understanding of the genetics of African populations, through various methods for biospecimen
collection
iii) Enhance neuropsychiatric genetic research capacity in Africa through the training of scientists and supporting
the development of locally-led research programs
Uganda 2025-08-27 14:38:09 2028-08-27 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Jackline  Akello
ID: UNCST-2023-R005827
Sickle cell disease in pregnancy: Experiences in provision and access to care and adverse pregnancy outcomes at Mbale and Kawempe Referral Hospitals
REFNo: HS5315ES

4.To explore health providers experiences in providing care to pregnant women with SCD at Mbale and Kawempe referral hospitals. ,To explore experiences of pregnant women with SCD in accessing health care at Kawempe and Mbale referral Hospitals. ,2.To determine risk factors for adverse fetal outcomes among pregnant women with SCD at Mbale and Kawempe Referral Hospitals,To determine risk factors for adverse maternal outcomes among pregnant women with SCD at Mbale and Kawempe Referral Hospitals ,The general objective is to determine the adverse maternal and fetal outcomes associated with pregnancies complicated by SCD and explore experiences in access and provision of care at Mbale and Kawempe Referral Hospitals. ,
Uganda 2025-01-10 11:54:49 2028-01-10 Medical and Health Sciences Non-Clinical Trial Degree Award
AKELLO REBECCA AGNESS
ID:
PREVALENCE, SEVERITY AND FACTORS ASSOCIATED WITH ANAEMIA AMONG WOMEN ADMITTED FOR DELIVERY AT TERM AT MBARARA REGIONAL REFERRAL HOSPITAL
REFNo: HS3067ES

3. To identify the factors associated with anaemia among women admitted for delivery at term at Mbarara Regional Referral Hospital,2. To describe the severity of anaemia among women admitted for delivery at term at Mbarara Regional Referral Hospital ,1. To determine the prevalence of anaemia among women admitted for delivery at term at Mbarara Regional Referral Hospital ,To determine the prevalence, severity and factors associated with anaemia among women admitted for delivery at term at Mbarara Regional Referral Hospital.,
Uganda 2023-10-23 13:09:03 2026-10-23 Medical and Health Sciences Non-Clinical Trial Degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
End of Project Evaluation for the Baylor Uganda SNAPS WEST Project
REFNo: HS227ES

Evaluation goal The goal of the evaluation is to establish the impact of SNAPS WEST project on HIV service delivery in the Rwenzori region. Evaluation Objectives General objective The general objective is to conduct an end of project evaluation to assess the extent to which the project has met the objectives as stated in the Funding Opportunity Announcement that led to this award. Specific objectives 1) To determine the extent to which “Strengthening National Paediatric HIV/AIDS and Scaling up Comprehensive HIV/AIDS Services in the Republic of Uganda under The President’s Emergency Plan For AIDS Relief project”: i. Scaled up access to paediatrics and adolescent HIV/AIDS/TB care and treatment at COE between 2012 and 2018 ii. Scaled up access to comprehensive HIV care and treatment services in the 7 districts of Rwenzori region between 2012 and 2018. iii. Supported MoH and its partners in a) Strengthening National Paediatric/Adolescent HIV/AIDS Care , b) providing training, mentorship and technical support supervision to RRHs and lower health facilities providing HIV care and ART services, c) providing expert consultation to health workers through the national paediatric and adolescent call centre. iv. Strengthened implementation of district based programming approach as well as support for integration of GHI principles into comprehensive HIV/AIDS care and treatment and other health services over the project period. 2) To assess the relevance of: i. The SNAPS WEST project strategies to the implementers (MOH, districts & Baylor Uganda Clinical Centre of Excellence staff) as well project challenges & recommendations for HIV programing in regard to HTC, PMTCT, Care and Treatment, SMC, OVCs, PP/KPs. ii. The SNAPS WEST project to; a) the HIV care needs of clients in the Rwenzori region and COE, b) as well as information needs for health workers using services of the national paediatric call centre. 3) Document project lessons learnt, challenges faced and make appropriate recommendations
Uganda 2018-08-31 2021-08-31 Medical and Health Sciences Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
Host Genetic Factors in Pediatric HIV/TB Infections II
REFNo: HS236ES

The cohort development core project of CAfGEN has several unique and innovative features. 1. This project will significantly expand what is currently the largest genomic cohort dedicated to pediatric HIV in Africa. 2. We will prospectively identify and recruit a cohort of HIV-positive, isoniazid naïve children with a strong exposure to TB, but without evidence of active TB disease – such TB resistant individuals are unique and highly desired in the field, even more so among children co-infected with HIV. This approach is highly conducive to high-level genetic mapping and thus has the potential to offer novel molecular insights into the development of active TB disease. 3. The current studies propose the expansion of our genomics studies to Swaziland – a Southern African population that is currently not represented on the African genomics map. This creates long-term opportunities to fulfill the stated desire to make the H3Africa initiative truly pan-African in scope. 4. The network will develop and extend the experience gained and lessons learned in implementing and pursuing genomics education and ethics consultation in furtherance of the mandate of engaging communities in genomics studies, which is key to long-term sustainability.
Uganda 2018-09-24 2021-09-24 Medical and Health Sciences Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
Project Evaluation Protocol for the ACE-FORT Project: Entitled; “Accelerating Epidemic Control in Fort Portal Region in the Republic of Uganda under the President’s Emergency Plan for AIDS Relief (PEPFAR)”
REFNo: HS740ES

i) To determine the extent to which the project; a) Increases the proportion of PLHIV with known HIV status by 2020, b) Increases the proportion of people diagnosed with HIV accessing ART by 2020, c) Increases proportion of people receiving ART who are virally suppressed by 2020, d) Achieves coverage of high impact combination prevention interventions in scale-up districts by 2020, e) Provides Healthy, Safe, Stable, Schooled, and case management services along the Continuum of Response to eligible OVC and their families and graduate families out of Vulnerability by 2023, f) Strengthens regional and district governance and systems for sustained epidemic control by 2023.
ii) To Assess the relevance of; a) Prevention services in reducing the incidence of HIV in Fort portal region, b)Treatment and care services in reducing HIV related morbidity and mortality, c) OVC services in reducing the vulnerability of families with HIV.
iii) To assess the potential for sustainability of project components, results achieved and other efforts aimed at achieving HIV epidemic control in Fort Portal region.
iv) To assess the cost of; a) identifying new HIV positive children and adults, b) retaining HIV positive clients in care, c) graduating OVC’s from vulnerability.

Uganda 2020-08-26 2023-08-26 Medical and Health Sciences Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
Novel and Optimized Diagnostics in Pediatric Tuberculosis in Kampala, Uganda(NOD)
REFNo: HS1341ES

The study has the following objectives:
Objective 1: Evaluate and develop novel assays that diagnose TB by detecting Mycobacterium tuberculosis (MTB) bacterial products in non-sputum body fluids. Objective 2: Evaluate and develop novel assays that diagnose TB by detecting host biomarkers in non-sputum body fluids.
Objective 3: Identify combinations of assays that applied together could be used to diagnose TB among children with unconfirmed.

Uganda 2021-05-18 2024-05-18 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
Mortality Surveillance Activity Protocol All-cause Mortality Surveillance in Bunyangabu, Kabarole and Kyenjojo districts, Uganda
REFNo: HS1755ES

the objective of establishing a mortality surveillance system is to enumerate and document all-cause mortality in the 3 districts of Bunyangabu, Kabarole, and Kyenjojo in Uganda. Specifically this will; a) determine HIV/AIDS related and proportionate mortality rate in the three districts, b) determine maternal and neonatal mortality rates in the three districts c) identify causes of death among HIV patients and causes of pregnancy-related deaths in the three districts and d) document the implementation process of mortality surveillance in order to inform future scale up.
Uganda 2021-10-12 2024-10-12 Medical and Health Sciences Non-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

Uganda 2021-11-15 2024-11-15 Medical and Health Sciences Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
Results Based Financing to achieve HIV/AIDS epidemic control in Fort Portal Region, Uganda A case study of Baylor-Uganda
REFNo: HS2227ES

The objectives of the RBF pilot include the following; a) To determine the effect of results-based financing on the performance of HIV and TB indicators in Fort Portal region, b) To estimate and compare cost to outcome ratios for performance on selected HIV/TB indicators before and after RBF implementation in selected health facilities and c) To describe the process and contextual factors affecting implementation of RBF for HIV indicators under the ACE-Fort project in Fort Portal region.
Uganda 2022-05-20 8:30:01 2025-05-20 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Adeodata Rukyalekere Kekitiinwa
ID: UNCST-2019-R000799
IMPAACT 2028: Long-Term Clinical, Immunologic, and Virologic Profiles of Children who Received Early Treatment for HIV; DAIDS Study ID #38693
REFNo: HS2417ES

To characterize the long-term clinical, immunologic, and Virologic profiles of children who received early treatment for perinatally-acquired HIV
Uganda 2023-02-06 16:17:13 2026-02-06 Medical and Health Sciences Non-Clinical Trial Non-degree Award
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