University of North Carolina at Chapel Hill Project-China, 7 Lujing Road, Guangzhou, 510091, Guangdong Province, China.
Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
BMC Public Health. 2022 Sep 7;22(1):1697. doi: 10.1186/s12889-022-14117-5.
Adherent pre-exposure prophylaxis (PrEP) uptake can prevent HIV infections. Despite the high HIV incidence, Chinese key populations have low PrEP uptake and adherence. New interventions are needed to increase PrEP adherence among key populations in China. Co-creation methods are helpful to solicit ideas from the community to solve public health problems. The study protocol aims to describe the design of a stepped-wedge trial and to evaluate the efficacy of co-created interventions to facilitate PrEP adherence among key populations in China.
The study will develop intervention packages to facilitate PrEP adherence among Chinese key populations using co-creation methods. The study will then evaluate the efficacy of the co-created intervention packages using a stepped-wedge randomized controlled trial. This four-phased closed cohort stepped-wedge design will have four clusters. Each cluster will start intervention at three-month intervals. Seven hundred participants who initiated PrEP will be recruited. Participants will be randomized to the clusters using block randomization. The intervention condition includes receiving co-created interventions in addition to standard of care. The control condition is the standard of care that includes routine clinical assessment every 3 months. All participants will also receive an online follow-up survey every 3 months to record medication adherence and will be encouraged to use a WeChat mini-app for sexual and mental health education throughout the study. The primary outcomes are PrEP adherence and retention in PrEP care throughout the study period. We will examine a hypothesis that a co-created intervention can facilitate PrEP adherence. Generalized linear mixed models will be used for the primary outcome analysis.
Developing PrEP adherence interventions in China faces barriers including suboptimal PrEP uptake among key populations, the lack of effective PrEP service delivery models, and insufficient community engagement in PrEP initiatives. Our study design addresses these obstacles by using co-creation to generate social media-based intervention materials and embedding the study design in the local healthcare system. The study outcomes may have implications for policy and intervention practices among CBOs and the medical system to facilitate PrEP adherence among key populations.
The study is registered in Clinical Trial databases in China (ChiCTR2100048981, July 19, 2021) and the US (NCT04754139, February 11, 2021).
坚持使用暴露前预防（PrEP）可以预防 HIV 感染。尽管 HIV 发病率很高，但中国的重点人群 PrEP 的使用率和坚持率都很低。需要新的干预措施来提高中国重点人群对 PrEP 的接受度和坚持率。共同创造方法有助于从社区征求意见以解决公共卫生问题。本研究方案旨在描述一项阶梯式随机对照试验的设计，并评估共同创造干预措施对提高中国重点人群对 PrEP 的坚持率的效果。
本研究将使用共同创造方法制定有助于中国重点人群坚持使用 PrEP 的干预方案。然后，我们将使用阶梯式随机对照试验评估共同创造干预方案的效果。本研究采用四阶段封闭队列阶梯式设计，有四个群组。每个群组将以每三个月为间隔启动干预。将招募 700 名开始使用 PrEP 的参与者。参与者将使用区组随机化分组。干预条件是在标准护理之外接受共同创造的干预措施。对照条件是标准护理，包括每 3 个月进行一次常规临床评估。所有参与者还将每 3 个月通过在线随访调查记录药物的坚持使用情况，并将在整个研究过程中鼓励他们使用微信迷你应用程序进行性健康和心理健康教育。主要结局指标是整个研究期间 PrEP 的坚持使用和 PrEP 护理的保留率。我们假设共同创造的干预措施可以促进 PrEP 的坚持使用。将使用广义线性混合模型进行主要结局分析。
在中国开发 PrEP 坚持使用的干预措施面临障碍，包括重点人群中 PrEP 的使用率较低、缺乏有效的 PrEP 服务提供模式以及社区参与 PrEP 计划不足。我们的研究设计通过使用共同创造生成基于社交媒体的干预材料，并将研究设计嵌入当地医疗保健系统，解决了这些障碍。研究结果可能对 CBO 和医疗系统在促进重点人群对 PrEP 的坚持使用方面的政策和干预措施产生影响。
本研究在中国临床试验数据库（ChiCTR2100048981，2021 年 7 月 19 日）和美国临床试验数据库（NCT04754139，2021 年 2 月 11 日）注册。
