A community-engaged mHealth intervention to increase uptake of HIV Pre-Exposure Prophylaxis (PrEP) among gay, bisexual and other men who have sex with men in China: Study protocol for a pilot randomized controlled trial

Introduction: Emtricitabine-Tenofovir was officially approved as the first medicine for HIV pre-exposure prophylaxis (PrEP) in China on August 11, 2020. The large number of key populations who would benefit from PrEP in the context of limited health system capacity and public awareness will pose challenges for timely PrEP scale-up. This suggests an urgent need for innovative and accessible intervention tools for promoting PrEP. Our overall goal is to develop and pilot test a theory-informed, tailored mobile phone intervention to increase engagement in PrEP education and initiation among Chinese gay, bisexual, and other men who have sex with men (GBMSM). We also aim to generate hypotheses of potential behavioral pathways to PrEP uptake among Chinese GBMSM. Methods and analysis: This two-phase study includes a formative assessment (Phase 1) using in-depth interviews (N=30) and a 12-week experimental pilot study (Phase 2) using a two-arm randomized controlled trial design (N=60). The primary intervention is delivered through a WeChat-based mini-app (a program built into a Chinese multipurpose social media application) developed by young GBMSM from a 2019 crowdsourcing hackathon. This participatory event brought together GBMSM, tech experts, health professionals, and other key stakeholders. This study will further investigate the specific needs and concerns among GBMSM in terms of using PrEP as an HIV prevention strategy, how their concerns and PrEP use behaviors may change with exposure to the mini-app intervention at 8-week and 12-week follow-up, and how we can further refine this intervention tool to better meet GBMSM needs for broader implementation. Ethics and dissemination: This study and its protocols have been reviewed and approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, USA (IRB#19-3481), the Guangdong Provincial Dermatology Hospital, China (IRB#2020031), and the Guangzhou Eighth People Hospital, China (IRB#202022155). Study staff will work with local GBMSM community-based organizations to disseminate the study results to participants and the community via social media, offline workshops, and journal publication. This research addresses a critical need as GBMSM bear a disproportionate burden of HIV infections and remain underserved in the healthcare system in China. Trial Registration: The study was registered on clinicaltrials.gov (Trial#: NCT04426656) on June 11, 2020. https://clinicaltrials.gov/ct2/show/NCT04426656. Prospectively registered.