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

暴露前预防(PrEP)在预防同性恋、双性恋者和 其他与男性(GBMSM)和变性女性(TW)发生性关系的男性，但依赖于这些高- 在PrEP护理连续体系中的多个步骤中的风险社区。研究表明，少数PrEP- 符合条件的GBMSM正在接受PrEP，TW比GBMSM不太可能听说过PrEP，与他们的 关于PrEP的供应商，在过去的6个月中使用PrEP，并一直遵守PrEP。现有的艾滋病毒检测和 由我们在加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 有资格参加PrEP的参与者对启动PrEP不感兴趣；在那些确实启动PrEP的人中，只有5.8%的人留了下来 3个月后服用PrEP。显然，创新的干预措施优化了对各种疾病的PrEP连续护理 需要GBMSM和TW。我们在这里提出了一种理论上有根据的(在IMB模型中)、有效的、可访问的 以及针对GBMSM和TW的可持续的mHealth PrEP护理连续干预，称为ESTEP(电子 支持参与PrEP)。EStep网络应用程序将根据性取向和性别状况进行定制，包括 在亲自进行艾滋病毒检测之前交付的一组互动组件(例如，关于以下项目好处的PrEP信息 准备)，并在参与者检测艾滋病毒呈阴性并同意开始PrEP(例如，依从性自我监测)之后。 目标1：使用迭代开发流程通过以下方式获得对EStep内容和功能的反馈 有GBMSM和TW的焦点小组和一个社区咨询委员会(CAB)。6个18-45岁的焦点小组 成立一年的GBMSM和TW(每组6名参与者；&gt；50%黑人/Latinx)将在 干预开发周期，以创建定制的(分别针对GBMSM和TW)IMB相关内容和 EStep的特点。将建立一个由GBMSM(n=3)和TW(n=3)组成的驾驶室，以在 几轮焦点小组。目标1将在3个GBMSM和3个TW之间的可用性测试中达到高潮，以最终完成EStep。 目的2：进行EStep的先导性随机对照试验，以评估其可行性、可接受性和 在为大规模R01做准备时GBMSM和TW之间的初步影响。120(50%种族/民族 少数)报告符合PrEP资格的风险因素的GBMSM(n=85)和TW(n=35)将被随机抽查 (2：1)至EStep干预组(n=80)或常规HIV检测对照组(n=40)。EStep小组将拥有 立即获得艾滋病毒前检测组件。所有研究参与者将被提供免费的面对面艾滋病毒检测 如果符合条件，还可以在大学艾滋病毒预防和治疗诊所进行PrEP。EStep参与者开始 Prep将解锁PrEP遵从性和持久性组件。跟进考察访问将于以下时间进行： 6个月来收集生物学、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测试完成、PrEP启动、PrEP坚持和PrEP 预约出席者)。最后，干预臂中的10个GBMSM和10个TW将参与退出 采访以获得对EStep的反馈，以期进行大规模的R01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.