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

暴露前预防（PrEP）在预防男同性恋、双性恋和变性人新的艾滋病毒感染方面非常有效。 其他与男性发生性关系的男性（GBMSM）和跨性别女性（TW），但依赖于这些高- 风险社区在多个步骤沿着PrEP护理连续。研究表明，少数PrEP- 符合条件的GBMSM正在服用PrEP，TW比GBMSM更不可能听说过PrEP，与他们的 关于PrEP的提供者，在过去6个月内使用过PrEP，并且一直坚持PrEP。现有的HIV检测和 由我们在加利福尼亚州圣地亚哥的研究团队成员领导的PrEP计划发现，超过60%的GBMSM和TW 符合PrEP资格的参与者对开始它不感兴趣;在那些开始PrEP的人中，只有5.8%的人留下来 三个月后的PrEP。显然，创新的干预措施，优化PrEP护理的多样性 需要GBMSM和TW。我们在这里提出了一个理论上的接地（在IMB模型），有效，可访问 和可持续的mHealth PrEP护理连续干预GBMSM和TW，称为eSTEP（电子 支持参与PrEP）。eSTEP网络应用程序将根据性行为和性别状态进行定制，包括 在亲自进行艾滋病毒检测之前提供的一组互动组件（例如，PrEP信息的好处 PrEP），并在参与者测试HIV阴性并同意开始PrEP（例如，自我监控（self-monitoring）。 目标1：使用迭代开发过程，通过以下方式获得有关eSTEP内容和功能的反馈 与GBMSM和TW以及社区咨询委员会（CAB）的焦点小组。6个重点小组，18-45人 将在3个关键点进行GBMSM和TW（6名参与者/组; > 50%黑人/拉丁裔） 干预开发周期，以创建量身定制的（分别针对GBMSM和TW）IMB相关内容， eSTEP的特点。将建立GBMSM（n=3）和TW（n=3）的CAB，以在以下方面提供指导： 焦点小组的回合。目标1将在3 GBMSM和3 TW之间进行可用性测试，以最终确定eSTEP。 目的2：对eSTEP进行初步随机对照试验，以评估其可行性、可接受性和 GBMSM和TW在准备大规模R 01时的初步影响。120例（50%种族/族裔 少数）GBMSM（n=85）和TW（n=35）报告符合PrEP资格的风险因素将被随机分配 （2：1）与eSTEP干预（n=80）或常规HIV检测对照（n=40）。eSTEP小组将有 立即获得艾滋病毒检测前的服务。所有研究参与者将获得免费的艾滋病毒检测 如果符合条件，还可以在大学艾滋病毒预防和治疗诊所接受PrEP。开始的eSTEP参与者 PrEP将解锁PrEP依从性和持久性组件。随访研究访视将在3- 6个月收集生物学、临床和自我报告的结果，以评估eSTEP的可行性， 可接受性和初步结果（HIV检测完成、PrEP启动、PrEP依从性和PrEP 预约出席）。最后，干预臂中的10个GBMSM和10个TW将参与退出 访谈，以获得对eSTEP的反馈，预期将进行大规模R 01研究。

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.