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 NxTekâ„¢ Malaria Pf Plus Rapid Test Device and NxTekâ„¢ 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 NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ 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 NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using a VWB sample, will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ 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 NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using VWB samples that have been exposed to 1x Freeze/Thaw cycle will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ 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 NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ 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 NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ 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
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