Stephen Watya
ID: UNCST-2025-R021507
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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).
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Uganda |
2021-08-16 |
2024-08-16 |
Medical and Health Sciences |
Non-Clinical Trial |
Non-degree Award |
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Violet Korutaro
ID: UNCST-2019-R000618
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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.,
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Uganda |
2021-08-16 |
2024-08-16 |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Helen Ndagije Byomire
ID: UNCST-2021-R013939
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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. ,
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Uganda |
2021-08-16 |
2024-08-16 |
Medical and Health Sciences |
Non-Clinical Trial |
Non-degree Award |
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Jonathan Kayondo
ID: UNCST-2021-R008325
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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).
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Uganda |
2021-08-16 |
2024-08-16 |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Rhoda Wanyenze
ID: UNCST-2021-R013352
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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.
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Uganda |
2021-08-16 |
2024-08-16 |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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