School of Public Health, University of the Western Cape, Cape Town, Western Cape, South Africa.
Division of Social and Behavioural Sciences, University of Cape Town, Cape Town, Western Cape, South Africa.
PLoS One. 2024 Aug 2;19(8):e0308128. doi: 10.1371/journal.pone.0308128. eCollection 2024.
Community engagement (CE) is pertinent to ethically and scientifically rigorous infectious disease clinical trials in sub-Saharan Africa (SSA). However, there are critiques that CE is not properly embedded in research processes and that there is uncertainty about what CE entails. The aim of this study was to gain an understanding of CE in infectious disease clinical trials in SSA, specifically factors affecting CE and existing strategies for engaging with communities.
Semi-structured telephone interviews were conducted with 20 community and clinical trial (CT) stakeholders who worked in SSA. The audio-recorded interviews were transcribed verbatim and analysed inductively using thematic analysis.
Themes are as follows: 1) Communities are abandoned research-entities-a disconnect between scientific teams and communities was observed and knowledge translation was not prioritised at the community-level. 2) Us and them: community engagement teams vs investigators-CE teams expressed that researchers did not account for CE processes and often did not involve CE staff in their planning, and felt that their roles were not valued. 3) Ethical considerations: concerns and gaps-there were concerns that procedures were not standardised and that ethics processes were not adhered to. 4) Opportunities for improved CE practices-training needs were expressed, including for standardised practices, ethics, and for developing a holistic understanding of collaborating with communities.
CE role players require intensive training to ensure ethical CE and that communities are treated with dignity. This includes 1) using collaborative strategies involving research and CE staff, 2) protocol-adherence that recognises CE as pertinent, 3) viewing communities as complex and building relationships that are sustainable, and 4) ensuring that knowledge translation is considered at a community-level. Further research is necessary to investigate potential training programmes that integrate these elements.
社区参与（CE）与撒哈拉以南非洲（SSA）的传染病临床研究的伦理和科学严谨性密切相关。然而，有人批评说，CE 并没有恰当地嵌入研究过程中，并且对于 CE 包含哪些内容存在不确定性。本研究旨在了解 SSA 传染病临床研究中的 CE，特别是影响 CE 的因素和与社区接触的现有策略。
对在 SSA 工作的 20 名社区和临床试验（CT）利益相关者进行了半结构式电话访谈。对录音的访谈进行了逐字转录，并使用主题分析进行了归纳分析。
主题如下：1）社区是被抛弃的研究实体——观察到科学团队与社区之间存在脱节，知识转化在社区层面没有得到优先考虑。2）我们和他们：社区参与团队与研究者——CE 团队表示，研究人员没有考虑 CE 流程，并且经常不邀请 CE 工作人员参与他们的计划，他们觉得自己的角色没有得到重视。3）伦理考虑：关注和差距——有人担心程序没有标准化，伦理程序没有得到遵守。4）改进 CE 实践的机会——表达了培训需求，包括标准化实践、伦理以及对与社区合作的整体理解。
CE 角色扮演者需要接受强化培训，以确保 CE 的伦理，并尊重社区。这包括 1）使用涉及研究和 CE 工作人员的协作策略，2）遵守承认 CE 重要性的方案，3）将社区视为复杂的，并建立可持续的关系，4）确保在社区层面考虑知识转化。需要进一步研究，以调查整合这些要素的潜在培训计划。
