Wits RHI, University of the Witwatersrand, Johannesburg, South Africa.
Department of Health Behavior at the UNC Gillings School of Global Public Health, Johannesburg, South Africa.
J Int AIDS Soc. 2018 Oct;21 Suppl 7(Suppl Suppl 7):e25175. doi: 10.1002/jia2.25175.
The Good Participatory Practice (GPP): Guidelines for Biomedical HIV Prevention Trials, second edition (2011) were developed to provide clinical trial sponsors and implementers with a formal stakeholder engagement framework. As one of the largest African research institutes, Wits Reproductive Health and HIV Institute (Wits RHI) became an early adopter of GPP by implementing its principles within large-scale national and regional clinical trials. This article examines Wits RHI's lessons learned from implementing GPP, its ongoing efforts to institutionalize GPP, and the yet to be realized potential in creating fully sustainable structures for meaningful stakeholder engagement in HIV prevention research, implementation science and beyond.
For the past seven years, Wits RHI has undertaken both centralized leadership roles in implementing GPP across multi-party regional research consortia as well as overseeing GPP for smaller investigator-driven trials. Through this iterative roll-out of GPP, key lessons have emerged. Obtaining upfront funding to support GPP activities throughout and between the research life cycle, and a trained multi-disciplinary team of GPP practitioners have helped facilitate an enabling environment for GPP implementation. We further recommend formally integrating stakeholder engagement into study documents, including monitoring and evaluation plans with indicators and performance metrics, to assist teams to track and refine their GPP strategies. Finally, institutionalizing resources and supporting organization-wide GPP along with ongoing support can help build efficiencies and maximize economies of scale toward a pragmatic and innovative application of the GPP Guidelines.
Thanks to a growing global network of GPP practitioners and a burgeoning GPP Community of Practice, there has been substantive progress in making GPP an integral component of clinical HIV prevention research. The Wits RHI experience highlights the possibilities and the challenges to translating the GPP principles into concrete practices within specific clinical trials and across a research institute. Realizing the full potential of GPP, including direct and indirect - 'collateral benefits' will require the collective buy-in and support from sponsors, implementers and community stakeholders across the research field. As the HIV prevention research field expands, however, a more conscious and systematic implementation of GPP is timely.
《良好参与实践(GPP)指南:第二版(2011 年)》是为生物医学 HIV 预防试验的临床试验赞助商和执行者制定的,为他们提供了一个正式的利益相关者参与框架。威特沃特斯兰德大学艾滋病毒与生殖健康研究所(Wits RHI)是非洲最大的研究机构之一,它通过在大型国家和区域临床试验中实施 GPP 原则,成为 GPP 的早期采用者。本文探讨了 Wits RHI 在实施 GPP 方面的经验教训、将 GPP 制度化的持续努力,以及在为 HIV 预防研究、实施科学和其他领域创造有意义的利益相关者参与的可持续结构方面尚未实现的潜力。
在过去的七年中,Wits RHI 不仅在多党派区域研究联盟中承担了实施 GPP 的集中领导作用,还负责监督较小的研究者驱动试验的 GPP。通过这种迭代式的 GPP 推广,出现了一些关键的经验教训。在整个研究周期内和周期之间获得支持 GPP 活动的前期资金,以及一支训练有素的多学科 GPP 从业者团队,有助于为 GPP 的实施创造有利环境。我们还建议正式将利益相关者的参与纳入研究文件,包括监测和评估计划中的指标和绩效指标,以帮助团队跟踪和完善他们的 GPP 策略。最后,将资源制度化并提供组织范围内的 GPP 支持以及持续的支持,可以帮助提高效率,最大限度地扩大规模经济,从而实现 GPP 指南的务实和创新应用。
由于 GPP 从业者的全球网络不断壮大,以及 GPP 实践社区的蓬勃发展,GPP 已成为临床 HIV 预防研究不可或缺的组成部分。Wits RHI 的经验突显了将 GPP 原则转化为具体临床试验和研究机构内具体实践的可能性和挑战。实现 GPP 的全部潜力,包括直接和间接的“附带利益”,需要研究领域内的赞助商、执行者和社区利益相关者的集体认可和支持。然而,随着 HIV 预防研究领域的扩大,更有意识和系统地实施 GPP 是适时的。