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 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 |
|
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.
|
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
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Uganda |
2021-08-11 |
2024-08-11 |
Medical and Health Sciences |
|
Non-degree Award |
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ANTHONY KAYIIRA
ID: UNCST-2020-R014108
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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.,
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Uganda |
2021-08-11 |
2024-08-11 |
Medical and Health Sciences |
Non-Clinical Trial |
Non-degree Award |
|
Abel Atukwase
ID:
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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.
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Uganda |
2021-08-11 |
2024-08-11 |
Agricultural Sciences |
Non-Clinical Trial |
Non-degree Award |
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Maxensia owor
ID: UNCST-2021-R014003
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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. 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 |
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