Project Title

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

Project Objectives

The objectives of the "Strengthening community engagement in TB and HIV vaccine trials in South Africa" (CETH) project are: 1. To identify current barriers and facilitators of community engagement in infectious disease clinical trials in sub-Saharan Africa. 2. To identify and evaluate existing strategies for engaging community stakeholders in infectious disease clinical trials in sub-Saharan Africa. 3. To explore current understandings, experiences and practices of community engagement at two vaccine trial sites (TB and HIV) in South Africa 4. 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

Results & Outcomes

Host Organisation

EDCTP Project Call

Career Development Fellowship (CDF)

Study Design

Qualitative evidence synthesis, qualitative case studies

Project Summary

Community engagement (CE) should involve a bi-directional partnership between community and research stakeholders to inform, consult, involve, collaborate and empower each other across the different stages of health research. There is debate around the adequacy of CE in new infectious disease vaccine clinical trials (CT) in South Africa, which highlights longstanding critiques that CE is not properly embedded in research processes. There was therefore a need to explore the issues affecting CE and identify potential strategies for strengthening CE in vaccine trials in South Africa. We employed a range of data collection strategies across the project to learn about the factors informing CE at various levels. The first stage of the study included a Cochrane qualitative evidence synthesis (QES), which was used to gain an in-depth understanding of factors affecting CE in infectious diseases CTs in SSA. Screening and data extraction using duplicate was followed by critical appraisal. Twenty-four studies were included in the QES, and thematic analysis was used. GRADE CERQual was used to assess the confidence in findings. This stage also included qualitative telephone interviews with twenty diverse community and clinical trial stakeholders across sub-Saharan Africa. Interviews were transcribed using thematic analysis. Gaps in scientific literacy emerged as a threat to sustainable CE from the QES results and interviews. Some CT staff were anxious as they did not understand the scientific terminology they used to communicate to communities. The need for a holistic understanding of communities was another theme, and it was apparent that socio-cultural nuances play a pivotal role in fostering engagement. The use of creative audio-visual tools was a valuable strategy for communicating scientific information to communities. For the second stage of the study, we conducted qualitative case studies at two clinical sites in South Africa (focused on HIV and TB, respectively). We purposively selected two case studies in the Western Cape Province (South Africa), with a total of 17 participants. Case study 1 had 4 CT staff/community advisory board members (CABs) who were individually interviewed (Zoom), including a senior research officer/principal investigator, a research officer, a CAB coordinator/researcher and a site manager. A further 4 CAB members were part of two in-person group interviews. Case study 2 entailed two in-person group interviews and four individual interviews, and participants included a community liaison officer, fieldworkers, CAB members, a clinical research worker and a doctor. Thematic analysis was used and Case study 2 revealed that CABs were allies to CT staff and that selecting CABs were tied to who could encourage access to participants and who is respected by communities. Moreover, staff mentioned that approaching communities in a considerate manner aids effective CE. From Case study 1 it was notable that staff viewed CE as outreach – with successful activities having been implemented. In addition, staff positioned CABs as responsible for CE and its challenges, and there was an overlap between the roles of CT staff/CABs (leading to role-confusion). At both sites, it appeared necessary to improve CE strategies through trial literacy, collaboration, and reduced role-confusion. For stage 2, we also conducted collaborative research, which involved an interactive webinar with CE/CT stakeholders globally. During this webinar, we disseminated key findings to a diverse group of stakeholders regarding barriers, facilitators and strategies for CE and asked them to verify these findings. For more information on the project please visit the project site at https://soph.uwc.ac.za/project-item/strengthening-community-engagement-in-tb-and-hiv-vaccine-trials-in-south-africa-ceth/

Current Organisation

South African Medical Research Council

Current Job Title

Senior Specialist Scientist

Biography

Publications