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 HIV 暴露前预防 (PrEP) 的接受度和依从性

• 批准号: 10469457
• 负责人: Karen MacDonell
• 金额: $ 17.56万
• 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/10469457
• 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; 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.

变性妇女（TGW），尤其是年轻TGW（18-29岁），是增长最快的HIV+之一 艾滋病毒患病率为15-28％的全球人口。泰国的成人艾滋病毒最高 亚洲的血清阳性，TGW中的HIV感染率很高（18％）。尽管有风险，但很少 干预措施针对年轻的TGW。有效的发育和文化限制干预措施是 需要在这种高危人群中防止艾滋病毒传播。广泛的技术提供了机会 用于创新的移动（MHealth）干预措施。暴露前预防（PREP）是有效的HIV 疾病预防控制中心（CDC）推荐的预防策略以及包括HIV阴性TGW在内的高危个人。 按规定服用时，PREP非常有效，但是准备和依从性较低，很高 TGW中的停药率。为了应对这些挑战，我们建议开发和驾驶 组件，基于技术的干预措施以促进准备使用。我们将适应现有的两项经验， 通过技术提供的，激励性的访谈干预措施专注于年轻泰国TGW的准备工作， 导致动机增强系统以进行准备和依从性（MES-PREP）。我们也会 完善并增强了“ Yacool”，这是一款移动应用程序，其集成的文本消息传递在我们的临床上开发和临床使用 泰国团队，开发“增强的Yacool”，用于TGW性别/性健康的自我管理（包括PREP）。 我们的主要目的是开发和评估由此产生的MHealth干预的初步效率。我们将 利用多相优化策略（大多数）来确定最有效的干预组件或 组件的组合以解决该人群中的准备使用情况。拟议的研究包括2个阶段 对应于R21和R33研究期。 IA期（R21）包括与Key的定性访谈 利益相关者通过主题分析来探索使用障碍和促进者的障碍和促进者 适应。 IB期（R21）由MES-PREP的适应和Beta测试和增强的Yacool组成 使用HIV阴性泰国TGW的社区顾问委员会的功能和可行性。在第二阶段（R33）中， 我们将进行最大的基于设计的试验，以评估可行性，可接受性和初步效率 Mes-Prep和Yacool。八十名HIV阴性的年轻TGW和80岁的年轻TGW 开始准备将被随机分为四个实验条件：1）标准准备咨询（SPC，控制）， 2）MES-PREP + SPC，3）增强的Yacool + SPC和4）Mes-Prep +增强的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。 初步影响将通过评估准备计划的比例和遵守水平的比例来评估 准备。 TGW将在基线和干预后1、3、6、9和12个月完成评估。生物标志物 将收集依从性和艾滋病毒/STI。项目完成后，我们将进行优化 使用PREP支持TGW的MHealth干预措施将准备在更大的效率试验中进行测试。