Optimizing an mHealth intervention to improve uptake and adherence of the HIV pre-exposure prophylaxis (PrEP) in vulnerable adolescents and emerging adults

变性妇女(TGW)，特别是年轻的TGW(18-29岁)，是艾滋病毒+增长最快的人群之一 全球艾滋病毒流行率为15%-28%的人群。泰国成人艾滋病病毒感染率最高 亚洲的血清阳性率，TGW中艾滋病毒感染率很高(18%)。尽管存在风险，但很少有人 干预措施针对的是年轻的TGW。有效的针对发展和文化的干预措施是 需要防止艾滋病毒在这一高危人群中传播。普及的技术提供了机会 用于创新的移动(MHealth)干预。暴露前预防是一种有效的艾滋病毒 疾控中心和世卫组织为高危个人，包括艾滋病毒阴性的TGW建议的预防战略。 PREP按处方服用非常有效，但PrEP的摄取率和依从性一直较低，而PREP的依从性较高 TGW中的停牌率。为了应对这些挑战，我们建议开发和试行一种多 组件、基于技术的干预措施，以促进PrEP的使用。我们将调整现有的两节课， 技术提供的激励性访谈干预措施，重点关注年轻的泰国TGW使用PrEP， 导致PrEP摄取和依从性的激励增强系统(MES-PrEP)。我们还将 完善和增强“YaCool”，这是一款集成了文本消息的移动应用程序，由我们的 泰国团队，为TGW性别/性健康自我管理(包括PrEP)开发“增强型YaCool”。 我们的主要目标是开发和评估由此产生的mHealth干预的初步效果。我们会 利用多阶段优化策略(MOST)确定最有效的干预组件或 解决这一人群中PrEP使用情况的组件组合。建议的研究包括两个阶段。 与R21和R33学习周期相对应。阶段IA(R21)包括与KEY的定性访谈 利益攸关方通过主题分析探索PrEP使用的障碍和促进者，为干预提供信息 适应。IB阶段(R21)包括MES-PrEP和增强型YaCool的改编和测试版测试 使用艾滋病毒阴性的泰国TGW的社区咨询委员会的功能性和可行性。在第二阶段(R33)， 我们将进行一项基于设计的试验，以评估该方案的可行性、可接受性和初步疗效 MES-PrEP和YaCool。服用PrEP的80名HIV阴性的年轻TGW和没有服用PrEP的80名年轻TGW 启动PrEP将被随机分为四种实验条件：1)标准PrEP咨询(SPC，对照)， 2)MES-PrEP+SPC，3)增强YaCool+SPC，4)MES-PrEP+增强YaCool+SPC。可行性和 干预的可接受性将通过使用模式和系统可用性量表进行评估。 初步影响将通过评估PrEP启动的比例和遵守 准备好了。TGW将在基线以及干预后1、3、6、9和12个月完成评估。生物标志物 将收集遵守预防接种计划和艾滋病毒/性传播感染的情况。项目完成后，我们将拥有一个优化的 MHealth干预使用PrEP支持TGW，将准备在更大的疗效试验中进行测试。

Transgender women (TGW), particularly young TGW (ages 18-29), are among the fastest growing HIV+ populations worldwide with HIV prevalence rates of 15-28%. Thailand has the highest adult HIV seroprevalence in Asia, with high prevalence rates of HIV infection among TGW (18%). Despite their risk, few interventions have targeted young TGW. Effective developmentally- and culturally-tailored interventions are needed to prevent HIV transmission in this high-risk population. Widespread technology offers opportunities for innovative mobile (mHealth) interventions. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended by the CDC and WHO for at-risk individuals, including HIV-negative TGW. PrEP is highly effective when taken as prescribed, but PrEP uptake and adherence have been low, with high discontinuation rates among TGW. To address these challenges, we propose to develop and pilot a multi- component, technology-based intervention to promote PrEP usage. We will adapt an existing two-session, technology-delivered, Motivational Interviewing intervention to focus on PrEP use in young Thai TGW, resulting in the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also refine and enhance “YaCool,” a mobile app with integrated text messaging developed and used clinically by our Thai team, to develop “enhanced YaCool” for TGW self-management of gender/sexual health (including PrEP). Our primary aim is to develop and assess preliminary efficacy of the resulting mHealth intervention. We will utilize a Multiphase Optimization Strategy (MOST) to identify the most effective intervention component or combination of components to address PrEP usage in this population. The proposed study includes 2 phases corresponding to the R21 and R33 study periods. Phase IA (R21) includes qualitative interviews with key stakeholders to explore barriers and facilitators of PrEP usage through thematic analysis to inform intervention adaptation. Phase IB (R21) consists of adapting and beta testing of MES-PrEP and enhanced YaCool for functionality and feasibility using a community advisory board of HIV-negative Thai TGW. In Phase II (R33), we will conduct a MOST design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and YaCool. Eighty HIV-negative young TGW who are on PrEP and 80 young TGW who are not starting PrEP will be randomized to four experimental conditions: 1) Standard PrEP Counseling (SPC, control), 2) MES-PrEP + SPC, 3) enhanced YaCool + SPC, and 4) MES-PrEP + enhanced YaCool + SPC. Feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. Preliminary impact will be assessed by evaluating the proportion of PrEP initiation and level of adherence to PrEP. TGW will complete assessments at baseline and 1, 3, 6, 9, and 12 months post-intervention. Biomarkers of adherence to PrEP and HIV/STI will be collected. Upon project completion, we will have an optimized mHealth intervention to support TGW using PrEP which will be ready for testing in a larger efficacy trial.