Global Health Research, FHI 360, Durham, NC, USA.
Treatment Action Group, New York, NY, USA.
J Int AIDS Soc. 2018 Oct;21 Suppl 7(Suppl Suppl 7):e25181. doi: 10.1002/jia2.25181.
Inadequate community and stakeholder engagement can lead to accusations that research is unethical and can delay or slow research or translation of results to practice. Such experiences have led major funders as well as regulatory and advisory bodies to establish minimal requirements for community and stakeholder engagement in HIV and other clinical research. However, systematic efforts to formally evaluate the contributions and impact of particular practices are lacking.
A theory of change framework aligned with Good Participatory Practice for TB clinical trials was used to develop a set of measures for use in a minimally burdensome survey of trial implementing sites. The survey was pre-piloted with three TB trial sites in North America, South America and Asia to assess the feasibility of surveying global research sites in a systematic way, and to see if the measures captured informative variation in the use of engagement strategies and desired outcomes. Surveys were conducted at baseline and six months. In-depth interviews were conducted with site staff prior to the baseline survey to understand how sites conceptualized the concepts underlying the framework and the extent to which they viewed their work as aligned with the framework.
Survey measures captured considerable variability in the intensity and variety of engagement strategies, both across sites and within sites over time, and moderate variability in outcomes. Interviews indicated that underlying concepts were often unfamiliar to staff at baseline, but the goals of engagement aligned well with existing values.
Brief, targeted surveys of trial sites to characterize use of broad strategies, specific practices and some outcomes are a feasible option for evaluating good participatory practice. Additional testing is warranted to assess and enhance validity, reliability and predictive value of indicators. Options for collecting outcome measures through additional objective means should be explored.
社区和利益相关者参与不足可能会导致研究不道德的指责，并可能导致研究延迟或减缓，或研究结果难以转化为实践。这些经历促使主要资助者以及监管和咨询机构为艾滋病毒和其他临床研究制定了社区和利益相关者参与的最低要求。然而，缺乏对特定实践的贡献和影响进行系统评估的努力。
采用与结核病临床试验良好参与实践一致的变革理论框架，制定了一套用于对试验实施地点进行非强制性调查的措施。该调查在北美、南美和亚洲的三个结核病试验点进行了预试点，以评估以系统的方式调查全球研究点的可行性，并了解这些措施是否可以捕捉到参与策略的使用和期望结果的信息变化。调查在基线和六个月时进行。在基线调查之前，对现场工作人员进行了深入访谈，以了解现场工作人员如何理解框架背后的概念，以及他们在多大程度上认为自己的工作与框架保持一致。
调查措施在参与策略的强度和多样性方面，无论是在各个站点之间还是在站点内部随时间的变化，都捕捉到了相当大的变化，并且在结果方面也有一定的变化。访谈表明，基线时工作人员对基本概念往往不熟悉，但参与的目标与现有价值观非常吻合。
对试验点进行简短、有针对性的调查，以描述广泛策略、具体实践和一些结果的使用情况，是评估良好参与实践的可行选择。需要进一步测试来评估和提高指标的有效性、可靠性和预测价值。应探讨通过其他客观手段收集结果衡量标准的选择。
