PI

• Dr Bey-Marrié Schmidt

Team Members

*indicates student or postdoctoral fellow

• A/Prof Christopher Colvin, University of Virginia
• Prof Charles Wiysonge, Cochrane South Africa, SAMRC
• Dr Myrna van Pinxteren, University of Cape Town
• Dr Primus Che Chi, KEMRI-Wellcome Trust Research Programme
• Prof Uta Lehmann
• *Dr Carmen Späth

Strengthening community engagement in TB and HIV vaccine trials in South Africa (CETH)

Through evidence synthesis and participatory action research, this EDCTP funded project seeks to gain an in-depth understanding of community engagement in clinical trials. ‘Ceth’ means to accomplish something outstanding and to do something very worthwhile for humanity.

Project period

01 September 2021 – 31 August 2024

Project Summary

Community engagement is increasingly recognised as foundational to ethically and scientifically rigorous clinical trials involving human participants in low- and middle-income country settings. If effective, it involves a bi-directional partnership between community and research stakeholders to inform, consult, involve, collaborate and empower each other across the different stages of beneficial research. There is currently public debate around the adequacy of community engagement in new infectious disease vaccine trials in South Africa. This highlights longstanding critiques that community engagement is not properly embedded in research processes and it is unclear what constitutes community engagement. There is therefore a need to explore the issues and identify potential strategies for strengthening community engagement in vaccine trials in South Africa.

The objectives of the “Strengthening community engagement in TB and HIV vaccine trials in South Africa” (CETH) project are:

• To identify current barriers and facilitators of community engagement in infectious disease clinical trials in sub-Saharan Africa
• To identify and evaluate existing strategies for engaging community stakeholders in infectious disease clinical trials in sub-Saharan Africa
• To explore current understandings, experiences and practices of community engagement at two vaccine trial sites (TB and HIV) in South Africa
• To strengthen community engagement in TB and HIV vaccine trials in South Africa, by developing a contextualised, validated and accessible framework for both community and clinical trial stakeholders

We will use a combination of methodologies, including conducting a Cochrane qualitative evidence synthesis (QES), interviews, observations, document reviews and focus group discussions, through which we expect to gain an in-depth understanding of the experiences and practices of community engagement at two clinical trial sites in South Africa.

This will inform the development of a language and format accessible framework for guiding community and clinical trial stakeholders’ engagement.

‘Ceth’ means to accomplish something outstanding and to do something very worthwhile for humanity.

Funders

• European and Developing Countries Clinical Trials Partnership (EDCTP)

Partners and Collaborators

• South African Tuberculosis Vaccine Initiative, University of Cape Town
• Desmond Tutu HIV Centre, University of Cape Town
• Vaccine Advocacy Resource Group
• South African National Clinical Trials Register, funded by the South African Medical Research Council (SAMRC) and South African Ministry of Health
• Pan African Clinical Trials Registry, funded by the South African Medical Research Council (SAMRC) and EDCTP
• Vaccines for Africa, University of Cape Town

Related Publications