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

优化移动医疗干预措施，以提高弱势青少年和新生成年人对艾滋病毒暴露前预防 (PrEP) 的接受度和依从性

• 批准号: 10311830
• 负责人: Karen MacDonell
• 金额: $ 22.88万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-13 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10311830
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Advisory Committees; Affect; Age; Asia; Awareness; Biological Markers; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical; Communities; Complex; Counseling; Country; Development; Drug usage; Employment; Epidemic; Face; Gender; Gender Identity; HIV; HIV Infections; HIV Seronegativity; HIV Seroprevalence; HIV/STD; Health; Health Personnel; Health system; High Prevalence; Individual; Intervention; Interview; Joints; Mentors; Methods; Modeling; Monitor; Motivation; Patient Recruitments; Pattern; Persons; Phase; Population; Prevalence; Prevention strategy; Preventive service; Process; Protocols documentation; Provider; Randomized; Recommendation; Research; Risk; Risk-Taking; Self Management; Sexual Health; System; Technology; Testing; Text Messaging; Thailand; Training Programs; Treatment Efficacy; Work; acceptability and feasibility; aged; base; design; effective intervention; efficacy trial; emerging adult; emerging adulthood; feasibility research; group intervention; high risk behavior; high risk population; improved; infection rate; innovation; intervention program; mHealth; mobile application; mobile computing; motivational enhancement therapy; multiphase optimization strategy; participant retention; post intervention; pre-exposure prophylaxis; prevent; recruit; response; satisfaction; scale up; sex; side effect; social stigma; substance use; success; therapy design; transgender women; transmission process; uptake; usability; vulnerable adolescent; webinar

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.

跨性别女性 (TGW)，尤其是年轻的 TGW（18-29 岁），是增长最快的 HIV+ 人群之一 全球艾滋病毒感染率高达 15-28% 泰国是成人艾滋病毒感染率最高的国家。 亚洲的血清流行率，TGW 中 HIV 感染率很高（18%），尽管存在风险，但很少有人这样做。 干预措施针对的是年轻的 TGW。 预防艾滋病毒在这一高危人群中传播所需的技术提供了机会。 创新的移动 (mHealth) 干预措施 暴露前预防 (PrEP) 是一种有效的艾滋病毒治疗方法。 CDC 和 WHO 针对高危人群（包括 HIV 阴性 TGW）推荐的预防策略。 按处方服用时 PrEP 非常有效，但 PrEP 的采用率和依从性较低，且较高 为了应对这些挑战，我们建议开发和试点多 组成部分，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次会议， 技术提供的动机访谈干预，重点关注泰国年轻 TGW 中 PrEP 的使用， 我们还将建立 PrEP 吸收和依从性动机增强系统 (MES-PrEP)。 完善和增强“YaCool”，这是一款集成短信的移动应用程序，由我们的临床医生开发和使用 泰国团队，开发“增强型YaCool”，用于TGW自我管理性别/性健康（包括PrEP）。 我们的主要目标是开发和评估由此产生的移动医疗干预措施的初步效果。 利用多阶段优化策略 (MOST) 来确定最有效的干预措施或 结合各个组成部分来解决该人群中 PrEP 的使用问题 拟议的研究包括 2 个阶段。 对应于 R21 和 R33 研究期的 IA 阶段 (R21) 包括对关键人物的定性访谈。 利益相关者通过主题分析探索 PrEP 使用的障碍和促进因素，为干预措施提供信息 IB 阶段 (R21) 包括 MES-PrEP 和增强型 YaCool 的适应和 beta 测试。 使用 HIV 阴性泰国 TGW 的社区咨询委员会的功能和可行性 在第二阶段 (R33)， 我们将进行基于 MOST 设计的试验，以评估其可行性、可接受性和初步功效 MES-PrEP 和 YaCool。80 名接受 PrEP 的 HIV 阴性年轻 TGW 和 80 名未接受 PrEP 的年轻 TGW。 开始 PrEP 将被随机分配到四种实验条件：1) 标准 PrEP 咨询（SPC，对照）， 2) MES-PrEP + SPC，3) 增强型 YaCool + SPC，以及 4) MES-PrEP + 增强型 YaCool + SPC 可行性和 干预措施的可接受性将通过使用模式和系统可用性量表进行评估。 将通过评估 PrEP 启动比例和坚持水平来评估初步影响 PrEP。TGW 将完成基线和干预后 1、3、6、9 和 12 个月的生物标志物评估。 项目完成后，我们将收集 PrEP 和 HIV/STI 的遵守情况，并进行优化。 使用 PrEP 支持 TGW 的 mHealth 干预措施将准备在更大规模的疗效试验中进行测试。