Article type
Abstract
Background
Community engagement (CE) is increasingly recognized as foundational to ethical and scientifically rigorous clinical research involving human participants. However, there is uncertainty about what CE entails, and there are critiques that CE is not systematically and meaningfully embedded in research processes.
Objectives
This study aimed to identify barriers, facilitators, and strategies of CE in infectious disease clinical trials (CTs) in sub-Saharan Africa (SSA) to aid the development of a contextualized, validated, and accessible framework for strengthening CE in CTs.
Methods
Phase 1 involved a qualitative evidence synthesis (QES) to gain a holistic understanding of CE in infectious disease CTs in SSA. Screening and data extraction was done in duplicate, followed by critical appraisal. Twenty-six studies were included in the QES, and data were analyzed using thematic analysis. GRADE-CERQual was used to assess confidence in the findings.
Phase 2 involved semistructured telephone interviews with 20 community and clinical trial stakeholders in SSA. Transcribed interviews were analyzed using thematic analysis. The interviews enabled stakeholders to reflect on and validate the barriers, facilitators, and strategies reported in the QES and those not captured in the literature.
Results
The QES findings revealed barriers (eg, gaps in trial literacy; legacies of colonialism, inequality, and scientific exploitation; limited room for local context), facilitators (eg, early and consistent engagement; incorporating context into plans) and known strategies for CE (eg, role of community coalitions, emphasis on priority-setting forums).
Themes from the telephone interviews were 1) communities as abandoned research entities, 2) community engagement teams versus investigators, 3) ethical concerns and gaps, and 4) opportunities for improved CE practices.
Conclusion
The study gave insight into various factors facilitating and threatening CE. Key messages include that there are gaps in trial literacy among clinical trial staff, who often found it difficult to communicate scientific terminology to communities. It is urged that standardized CE strategies accounting for community and linguistic diversity and that incorporate appropriate communication of scientific information be developed. Lessons learned provide comprehensive insight into additional facilitators and barriers for enhanced CE practices, and findings can inform recommendations and interventions for strengthening CE in infectious disease CTs in SSA.
Community engagement (CE) is increasingly recognized as foundational to ethical and scientifically rigorous clinical research involving human participants. However, there is uncertainty about what CE entails, and there are critiques that CE is not systematically and meaningfully embedded in research processes.
Objectives
This study aimed to identify barriers, facilitators, and strategies of CE in infectious disease clinical trials (CTs) in sub-Saharan Africa (SSA) to aid the development of a contextualized, validated, and accessible framework for strengthening CE in CTs.
Methods
Phase 1 involved a qualitative evidence synthesis (QES) to gain a holistic understanding of CE in infectious disease CTs in SSA. Screening and data extraction was done in duplicate, followed by critical appraisal. Twenty-six studies were included in the QES, and data were analyzed using thematic analysis. GRADE-CERQual was used to assess confidence in the findings.
Phase 2 involved semistructured telephone interviews with 20 community and clinical trial stakeholders in SSA. Transcribed interviews were analyzed using thematic analysis. The interviews enabled stakeholders to reflect on and validate the barriers, facilitators, and strategies reported in the QES and those not captured in the literature.
Results
The QES findings revealed barriers (eg, gaps in trial literacy; legacies of colonialism, inequality, and scientific exploitation; limited room for local context), facilitators (eg, early and consistent engagement; incorporating context into plans) and known strategies for CE (eg, role of community coalitions, emphasis on priority-setting forums).
Themes from the telephone interviews were 1) communities as abandoned research entities, 2) community engagement teams versus investigators, 3) ethical concerns and gaps, and 4) opportunities for improved CE practices.
Conclusion
The study gave insight into various factors facilitating and threatening CE. Key messages include that there are gaps in trial literacy among clinical trial staff, who often found it difficult to communicate scientific terminology to communities. It is urged that standardized CE strategies accounting for community and linguistic diversity and that incorporate appropriate communication of scientific information be developed. Lessons learned provide comprehensive insight into additional facilitators and barriers for enhanced CE practices, and findings can inform recommendations and interventions for strengthening CE in infectious disease CTs in SSA.