eSTEP: An integrated mHealth intervention to engage high-risk individuals along the full PrEP care continuum

eSTEP：一种综合移动医疗干预措施，让高危人群参与整个 PrEP 护理连续过程

• 批准号: 10675096
• 负责人: Keith Joseph Horvath
• 金额: $ 23.08万
• 依托单位: SAN DIEGO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10675096
• 关键词: AIDS prevention; Address; Adherence; Agreement; Appointment; Awareness; Behavioral; Biological; Bisexual; Black race; Blood; Caring; Clinic; Clinical; Communities; Continuity of Patient Care; Data; Databases; Development; Devices; Dose; Dryness; Electronics; Eligibility Determination; Epidemic; Feedback; Focus Groups; Follow-Up Studies; Gays; Gender; Goals; HIV; HIV Infections; HIV Seronegativity; Health; Hearing; Human immunodeficiency virus test; Individual; Internet; Intervention; Interview; Latinx; Minority; Modeling; Monitor; Motivation; Outcome; Participant; Patient Self-Report; Persons; Preparation; Procedures; Process; Provider; Publishing; Qualifying; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Resources; Risk Factors; Risk Reduction; Running; Series; Services; Sexual Health; Sexuality; Site; Spottings; Stigmatization; Surveys; Testing; Time; Universities; Visit; acceptability and feasibility; care outcomes; eHealth; eligible participant; ethnic minority; flexibility; high risk; high risk population; human centered design; improved; innovation; mHealth; meetings; member; men; men who have sex with men; pre-exposure prophylaxis; prevent; primary outcome; programs; racial minority; scale up; secondary outcome; skills; social stigma; therapy development; transgender women; treatment arm; uptake; usability; web site; willingness

Pre-exposure prophylaxis (PrEP) is highly-effective in preventing new HIV infections among gay, bisexual and other men who have sex with men (GBMSM) and transgender women (TW), but relies on engaging these high- risk communities at multiple steps along the PrEP continuum of care. Studies show that a minority of PrEP- eligible GBMSM are taking PrEP, and TW are less likely than GBMSM to have heard of PrEP, talked with their provider about PrEP, used PrEP in the past 6 months, and been adherent to PrEP. An existing HIV testing and PrEP program led by members of our study team in San Diego, CA found that over 60% of GBMSM and TW participants eligible for PrEP were not interested in starting it; of those who did start PrEP, only 5.8% remained on PrEP after 3 months. Clearly, innovative interventions that optimize the PrEP continuum of care for diverse GBMSM and TW are needed. We propose here a theoretically-grounded (in the IMB model), effective, accessible and sustainable mHealth PrEP care continuum intervention for GBMSM and TW, called eSTEP (Electronic Support To Engage with PrEP). The eSTEP WebApp will be tailored by sexuality and gender status and include a set of interactive components delivered before in-person HIV testing (e.g., PrEP information on the benefits of PrEP) and after the participant tests HIV-negative and agrees to start PrEP (e.g., adherence self-monitoring). Aim 1: Use an iterative development process to gain feedback on eSTEP content and features through focus groups with GBMSM and TW and a community advisory board (CAB). 6 focus groups with 18-45 year-old GBMSM and TW (6 participants/group; > 50% Black/Latinx) will be conducted at 3 key points in the intervention development cycle to create the tailored (separately for GBMSM & TW) IMB-related content and features of eSTEP. A CAB of GBMSM (n=3) and TW (n=3) will be established to provide guidance between rounds of focus groups. Aim 1 will culminate in usability testing among 3 GBMSM and 3 TW to finalize eSTEP. Aim 2: Conduct a pilot randomized controlled trial of eSTEP to assess its feasibility, acceptability, and preliminary impact among GBMSM and TW in preparation for a large-scale R01. 120 (50% racial/ethnic minority) GBMSM (n=85) and TW (n=35) who report risk factors that qualify for PrEP eligibility will be randomized (2:1) to the eSTEP intervention (n=80) or a usual HIV testing control (n=40). The eSTEP group will have immediate access to pre-HIV testing components. All study participants will be offered free in-person HIV testing and, if eligible, PrEP at a university-based HIV prevention and treatment clinic. eSTEP participants who begin PrEP will unlock PrEP adherence and persistence components. Follow-up study visits will be conducted at 3- and 6-months to collect biological, clinical, and self-reported outcomes to assess eSTEP’s feasibility, acceptability, and preliminary outcomes (HIV test completion, PrEP initiation, PrEP adherence, and PrEP appointment attendance). Finally, 10 GBMSM and 10 TW in the intervention arm will participate in an exit interview to gain feedback on eSTEP in anticipation of a large-scale R01 study.

暴露前预防（PrEP）在预防同性恋、双性恋和同性恋者中新的艾滋病毒感染方面非常有效