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  
Stella Muyanja Zawedde
ID: UNCST-2021-R014037
Computer aided detection of Tuberculosis using chest radiography: A clinical validation of the CAD4TB version 7 system.
REFNo: HS1575ES

The primary objective will be to:
a) To determine the sensitivity and specificity of different CAD4TB v7 scores for the detection of bacteriologically confirmed tuberculosis (using Xpert Ultra® as the reference standard) in the Ugandan population.

The secondary objectives will be to
b) To determine the optimal combination of symptoms and chest x-ray features to be used to when triaging patients at the outpatient and HIV clinics.
To determine the most cost-effective algorithm to be used while to screen for TB among patients presenting to the outpatient and HIV clinics in Gulu and Kitgum.

Uganda 2021-08-16 2024-08-16 Medical and Health Sciences Non-Clinical Trial Non-degree Award
VICTOR TUMUKUNDE SPECTOR
ID:
Assessment of the validity of the measurement of kangaroo mother care duration in a hospital in Uganda: an observational study
REFNo: HS1589ES

o To assess the accuracy of caregiver report on duration of skin-to-skin contact (SSC) in the KMC position among neonates ≤2000g before stabilization.
o To assess the accuracy of healthcare workers’ report on duration of SSC in the KMC position among neonates ≤2000g before stabilization.
o To assess the reproducibility of the two methods of measuring KMC duration.
o To assess the reliability (inter-observer agreement) of gold standard direct observation.

Uganda 2021-08-16 2024-08-16 Medical and Health Sciences Non-Clinical Trial Degree Award
Stephen Watya
ID: UNCST-2025-R021507
UNDERSTANDING PROSTATE CANCER IN MEN OF AFRICAN ANCESTRY.
REFNo: HS1514ES

GENERAL OBJECTIVE
The goal of this project is to understand the genetics and epidemiology of prostate cancer in men of African ancestry.
Specific Objectives (SO):
1. To study common and rare germline variation in association with prostate cancer risk in men of African ancestry, using cutting edge genotyping and sequencing techniques. (UGPCS)
2. To determine non-genetic risk factors associated with prostate cancer among men of African ancestry. (UGPCS)
3. To identify germline and tumor genomic/molecular determinants of aggressive prostate cancer and disease progression in men of African ancestry. (UGPCS)
4. To determine the acceptability and validity of a rapid screening kits for prostate cancer in the Ugandan population. (UGPCS-epi)
5. To assess population level determinants of high PSA (≥4 n/gm) in men of African ancestry (UGPCS-epi).
6. To explore whether circulating tumor cells and circulating tumor DNA can be detected in the blood of men with aggressive prostate cancer and may be used to screen for aggressive disease (UGPCS-screen).
7. To determine disease progression of prostate cancer from the time of presentation among Ugandan men. (UGPCS-screen).

Uganda 2021-08-16 2024-08-16 Medical and Health Sciences Non-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.,
Uganda 2021-08-16 2024-08-16 Medical and Health Sciences Clinical Trial Non-degree Award
Helen Ndagije Byomire
ID: UNCST-2021-R013939
Skepticism on the Safety and Quality of Generic Medicines from countries with Non-stringent Regulatory Authorities in Uganda.
REFNo: HS1550ES

3. To establish knowledge, attitude and perceptions of health workers and the general population towards generic medicines from countries with the SRAs and those from the N-SRA including Uganda.,2. To compare the quality of selected registered generic medicines on the Ugandan market sourced from countries with SRAs and those from N-SRA including Uganda against the innovator product. ,1. To compare the nature and proportion of adverse drug reactions (ADRs) received by NDA in the period of June 2016 to June 2020 for selected generics from SRAs and those from the N-SRA against the innovator product.,To compare the quality and safety of selected generic medicines on the Ugandan market sourced from countries with Stringent Regulatory Authorities (SRAs) with those from non-stringent regulatory authorities N-SRAs including Uganda. ,
Uganda 2021-08-16 2024-08-16 Medical and Health Sciences Non-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 NxTek™ Malaria Pf Plus Rapid Test Device and NxTek™ 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 NxTek™ Malaria Pf/Pv Plus and NxTek™ 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 NxTek™ Malaria Pf Plus and NxTek™ Malaria Pf/Pv Plus Rapid Test using a VWB sample, will be evaluated against the NxTek™ Malaria Pf Plus and NxTek™ 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 NxTek™ Malaria Pf Plus and NxTek™ Malaria Pf/Pv Plus Rapid Test using VWB samples that have been exposed to 1x Freeze/Thaw cycle will be evaluated against the NxTek™ Malaria Pf Plus and NxTek™ 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 NxTek™ Malaria Pf/Pv Plus and NxTek™ 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 NxTek™ Malaria Pf/Pv Plus and NxTek™ 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).

Uganda 2021-08-16 2024-08-16 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.
Uganda 2021-08-16 2024-08-16 Medical and Health Sciences Clinical Trial Non-degree Award
Vandana Sharma
ID:
Assessing StrongMinds’ Community-based Therapy Groups with a Gender Lens
REFNo: SS954ES

The overall objective of this research is to better understand gender outcomes of StrongMinds programming, including the experience of women participants of both in-person and remote IPT-G with respect to safety and GBV risks.
Canada 2021-08-16 2024-08-16 Social Science and Humanities Non-Clinical Trial Non-degree Award
Achilles Katamba
ID: UNCST-2019-R000540
Validating a Clinical Risk Score for early Management of Tuberculosis in Ugandan Primary Health Clinics - PredicTB study
REFNo: HS1622ES

1. To evaluate the effectiveness of the PredicTB clinical risk score on clinical outcomes. 2. To evaluate the implementation of the PredicTB clinical risk score. 3. To project the long-term impact and cost-effectiveness of PredicTB implementation.
Uganda 2021-08-16 2024-08-16 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Denis Muhangi
ID:
Enhancing Institutional Capacity for Ethical Conduct of Research Involving Animals
REFNo: A141ES

Program objectives
1. To enhance technical capacity of MakSVAR-IACUC to international accreditation level.
2. Establish an Institutional Biosafety committee at the College of Veterinary Medicine, Animal Resources and Biosecurity.
3. To enhance awareness of the national guidelines for the use of animals in research and teaching among researchers and training institutions.

Specific study objectives

1. To determine the status of practices for the ethical conduct for research involving animals in Uganda.
2. To evaluate the available practices for ethical conduct for intervention.

Uganda 2021-08-16 2024-08-16 Agricultural Sciences Non-Clinical Trial Non-degree Award
Kenneth Ssebambulidde Ssebambulidde
ID: UNCST-2021-R013976
Relationship between maternal or newborn cholesterol levels and neonatal septicaemia: A Ugandan cohort of mother-new-born pairs
REFNo: HS1204ES

Primary objective: To elucidate a relationship between maternal and neonatal cholesterol levels and neonatal septicaemia

Secondary objectives:
1. To determine whether abnormal maternal cholesterol levels are associated with a risk for neonatal septicaemia.
2. To describe the correlation between maternal cholesterol levels and cord blood neonatal cholesterol levels at birth.
3. To determine the association between cord blood cholesterol levels and neonatal septicaemia

Uganda 2021-08-11 2024-08-11 Medical and Health Sciences Non-degree Award
ANTHONY KAYIIRA
ID: UNCST-2020-R014108
Prognostic value of serum hCG-β level, 12 days after embryo transfer, on predicting live birth among Ugandan women.
REFNo: HS1569ES

4. To determine the sensitivity and specificity of serum hCG-β level cut offs, 12 days after embryo transfer, on predicting pregnancy loss,3. To determine the sensitivity and specificity of serum hCG-β level cut offs, 12 days after embryo transfer, on predicting clinical pregnancy ,2. To determine the sensitivity and specificity of serum hCG-β level cut offs, 12 days after embryo transfer, on predicting biochemical pregnancy ,1. To determine the sensitivity and specificity of serum hCG-β level cut offs, 12 days after embryo transfer, on predicting live birth,To evaluate the prognostic value of serum hCG-β level cut off, 12 days after embryo transfer, on predicting pregnancy outcome among Ugandan women following an IVF-ET cycle.,
Uganda 2021-08-11 2024-08-11 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Abel Atukwase
ID:
EXPOSURE ASSESSMENT AND ANALYSIS OF HEALTH RISKS ASSOCIATED WITH CONSUMPTION OF AFLATOXIN CONTAMINATED STAPLES IN UGANDA
REFNo: A132ES

The overall objective of the project is to generate information that will guide the development of evidence-based policies and strategies for management of health risks associated with aflatoxins in Uganda. The specific objectives are to;
1. Determine the levels of aflatoxins in maize, sorghum and groundnuts produced and consumed in Uganda
2. Assess aflatoxin exposure among children (6-59 months) and women of reproductive age (15-49 years)
3. Characterise the health risks associated with consumption of maize, sorghum and groundnuts among children 6-59 months and women of reproductive age (15-49 years)
4. Develop policy briefs aimed at improving awareness amongst policy makers and stimulate formulation of policies and strategies for mitigating aflatoxin associated health risks.
Uganda 2021-08-11 2024-08-11 Agricultural Sciences Non-Clinical Trial Non-degree Award
Maxensia owor
ID: UNCST-2021-R014003
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. Version 3.0, dated 13 August 2020
REFNo: HS1356ES

Primary Objectives:
Cohort 1
1.To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents
2.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
Cohort 2:
1.To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents
Secondary Objectives: Cohort 1
• To monitor maintenance of viral suppression through Week 16 in HIV-infected, virologically suppressed adolescents
• To evaluate the tolerability and acceptability of CAB LA through Week 16 in HIV-infected,virologically suppressed adolescents
• To evaluate the tolerability and acceptability of RPV LA through Week 16 in HIV-infected,virologically suppressed adolescents
Secondary Objectives: Cohort 2
• To assess safety of oral CAB + oral RPV followed by CAB LA + RPV LA through Week 48 in HIVinfected, virologically suppressed adolescents
• To evaluate repeat-dose pharmacokinetics of CAB LA + RPV LA through Week 24, and through
Week 48 in HIV-infected, virologically suppressed adolescents.
• To assess antiviral activity of CAB LA + RPV
Uganda 2021-08-11 2024-08-11 Medical and Health Sciences Clinical Trial Non-degree Award
John Gitta Kavuma
ID:
Corporate Governance and Christian Organisational Culture in Anglican Church Founded Universities in Uganda
REFNo: SS794ES

1-To analyse the effect of corporate governance on university policies in Ndejje and UCU.

2-To assess the relationship between governing Policies and Christian values at Ndejje and UCU

3-To evaluate the influence of Christian values on organizational culture of Ndejje and UCU.

4-To compute the contribution of Corporate Governance on promoting Christian
organizational culture.
Uganda 2021-08-11 2024-08-11 Social Science and Humanities Non-Clinical Trial Degree Award
Jimmy, Maguru Mugisha Maguru
ID:
The ‘unexpected visitors’ and ‘good-host’ discourse: Social Accountability, Policy and Realities of Sexual and Reproductive Health of young people in two refugee settlements in Uganda
REFNo: SS828ES

1. To examine governance and accountability mechanisms of sexual and reproductive
health service delivery of the young refugees in refugee settlements in Uganda.
2. To examine the role of young refugees in the governance mechanisms of SRH and the
accountability chain and how this influences their ability to voice and to access SRH
services in refugee settings
3. To explore the challenges faced by young refugees and their coping mechanisms in
accessing and utilizing the ASRH services in refugee settlements in Uganda.

Uganda 2021-08-11 2024-08-11 Social Science and Humanities Non-Clinical Trial Degree Award
Violet Nakibuuka
ID: UNCST-2021-R003675
PREVALENCE AND FACTORS ASSOCIATED WITH HUMAN PAPILLOMA VIRUS VACCINATION AMONG ADOLESCENTS GIRLS AGED 9 TO 19 YEARS LIVING WITH HIV AT MULAGO ISS CLINIC, KAMPALA, UGANDA
REFNo: HS1436ES

1. To determine the prevalence of HPV vaccination among HIV positive adolescent girls aged 9-19 years at Mulago ISS Clinic, Kampala, Uganda.
2. To determine the factors associated with HPV vaccination among HIV positive adolescent girls aged 9-19 years at Mulago ISS Clinic Kampala, Uganda
3. To explore the perspectives, perceptions and experiences of healthcare providers, adolescent girls and their care takers at Mulago ISS Clinic regardingHPV vaccination among HIV positive adolescent girls.

Uganda 2021-08-11 2024-08-11 Medical and Health Sciences Non-Clinical Trial Degree Award
Derry Taylor James
ID:
Learned social knowledge in chimpanzees
REFNo: NS269ES

To understand the nature of chimpanzee social knowledge and how it is acquired
UK 2021-08-11 2024-08-11 Natural Sciences Non-Clinical Trial Non-degree Award
MOSES EGESA
ID: UNCST-2025-R015361
Epitope mapping of schistosome tegument and alimentary tract proteins in humans
REFNo: HS1463ES

1. To determine the change in antibody reactivity profile of individuals of an endemic area to epitopes of tegument and alimentary tract proteins before and after PZQ treatment
2. To identify antibody reactivity to epitopes putatively associated with protection against reinfection


Uganda 2021-08-11 2024-08-11 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Pontiano  Kaleebu
ID: UNCST-2020-R019901
Field Performance Evaluation of the m-PIMA™ 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-PIMA™ 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-PIMA™ 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-PIMA™ HIV-1/2 VL plasma assay by the study participants

Uganda 2021-08-11 2024-08-11 Medical and Health Sciences Clinical Trial Non-degree Award
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