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

跨性别妇女，特别是年轻的跨性别妇女（18-29岁），是艾滋病毒阳性人数增长最快的群体之一。 艾滋病毒感染率为15- 28%。泰国成人艾滋病毒感染率最高 亚洲的艾滋病毒感染率最高，在图瓦卢妇女中艾滋病毒感染率很高（18%）。尽管有风险，但很少有人 干预措施针对的是年轻的过渡妇女。有效的针对发展和文化的干预措施是 预防艾滋病毒在这一高危人群中的传播。广泛的技术提供了机会 创新的移动的（mHealth）干预措施。暴露前预防（Pre-exposure prophylaxis，PrEP） CDC和WHO为高危人群推荐的预防策略，包括HIV阴性的TGW。 当按规定服用时，PrEP是非常有效的，但PrEP的摄取和依从性很低， TGW中的中断率。为了应对这些挑战，我们建议开发和试点一个多- 组件，基于技术的干预，以促进PrEP的使用。我们将调整现有的两个会议， 技术交付，动机访谈干预，重点是在年轻的泰国TGW的PrEP使用， 这就是“PrEP吸收和坚持的动机增强系统”（MES-PrEP）。我们还将 完善和增强“YaCool”，这是一款由我们开发并在临床上使用的带有集成文本消息的移动的应用程序。 泰国团队，为TGW的性别/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干预措施的初步疗效。我们将 利用多阶段优化策略（MOST）确定最有效的干预措施，或者 这些组件的组合，以解决该人群中的PrEP使用。拟议研究包括两个阶段 对应于R21和R33研究期。第一阶段（R21）包括与关键人员进行定性访谈， 利益相关者通过专题分析探索PrEP使用的障碍和促进因素，为干预提供信息 适应IB阶段（R21）包括MES-PrEP和增强型YaCool的适应和beta测试， 功能性和可行性，使用艾滋病毒阴性泰国TGW的社区咨询委员会。在第二阶段（R33）， 我们将进行一项基于MOST设计的试验，以评估以下方法的可行性、可接受性和初步疗效： MES-PrEP和YaCool。80名正在接受PrEP的艾滋病毒阴性年轻TGW和80名未接受PrEP的TGW 将开始的PrEP随机分为四种实验条件：1）标准PrEP咨询（SPC，对照）， 2)MES-PrEP + SPC，3）增强型YaCool + SPC，和4）MES-PrEP +增强型YaCool + SPC。可行性和 将通过使用模式和系统可用性量表评估干预的可接受性。 初步影响将通过评估PrEP启动的比例和遵守的水平进行评估。 制备型TGW将在基线和干预后1、3、6、9和12个月完成评估。生物标记 将收集遵守PrEP和HIV/STI的情况。在项目完成后，我们将有一个优化的 mHealth干预，以支持TGW使用PrEP，这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.