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

Countdown to 2030

16 November 2021

Knowledge Translation Platforms for bridging public health and health systems research into Universal Health Coverage related policy and practice in South Africa (KTP-UHC)

10 December 2021

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

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 December 2024

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. The objective of the study was to investigate the multi-level factors that affect CE in infectious disease CTs in sub-Saharan 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 1 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 2 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.

We have presented at several local and international conferences, including at the Public Health Association of South Africa conference (PHASA), Cochrane Colloquium, and the Global Evidence Summit. We have published three journal publications, and we have disseminated infographics (translated into Afrikaans and isiXhosa), a video clip and booklet to 20 telephone interview participants, 17 case study participants, 45 survey respondents, 18 stakeholders representing 13 organisations, and 190 individuals who showed interest in being kept informed about the study.

In conclusion, in this study, we learned valuable lessons about CE. Some barriers included that communities seemed to be left out of the CE and CT conversation during early research stages, and it appeared that community input was not sought throughout the research project. There appeared to be limited room for the local context, and socio-cultural factors that shape CE were not prioritised in research planning. Facilitators of CE included incorporating cultural and contextual nuance in studies and empowering the community on the importance of CTs through dissemination methods. Multicomponent, transdisciplinary, and creative/arts-based methods might be valuable tools for enhancing sustainable CE in research.

The implications of the study include the advocacy for public and patient engagement in health research. We determined that a key strategy that could enhance CE practices in CT research, is to involve different community stakeholders in CT/CE planning throughout the research process, while adequately considering the community as multifaceted and shaped by social/historical/cultural dimensions.