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 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).
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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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Vandana Sharma
ID:
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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.
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Canada |
2021-08-16 |
2024-08-16 |
Social Science and Humanities |
Non-Clinical Trial |
Non-degree Award |
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Achilles Katamba
ID: UNCST-2019-R000540
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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.
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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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Denis Muhangi
ID:
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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.
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Uganda |
2021-08-16 |
2024-08-16 |
Agricultural Sciences |
Non-Clinical Trial |
Non-degree Award |
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