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

基本信息

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
项目类别：
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

项目摘要

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) 对于预防同性恋、双性恋和新发艾滋病毒感染非常有效。其他与男性发生性关系的男性（GBMSM）和跨性别女性（TW），但依赖于与这些高研究表明，少数 PrEP 患者在 PrEP 连续护理过程中处于多个阶段。符合资格的 GBMSM 正在采取 PrEP，而 TW 比 GBMSM 听说过 PrEP、与他们交谈过的可能性更低提供者了解 PrEP，在过去 6 个月内使用过 PrEP，并且一直遵守 PrEP 现有的 HIV 检测和治疗。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 项目发现，超过 60% 的 GBMSM 和 TW 符合 PrEP 资格的参与者对开始 PrEP 不感兴趣；在那些确实开始 PrEP 的参与者中，只有 5.8% 仍然存在显然，创新的干预措施可以优化不同人群的 PrEP 连续护理。我们在这里提出了一个有理论依据的（在 IMB 模型中）、有效的、可访问的。 GBMSM 和 TW 的可持续 mHealth PrEP 护理连续干预措施，称为 eSTEP（电子支持参与 PrEP）。 eSTEP Web 应用程序将根据性取向和性别状况进行定制，并包括以下内容：在进行现场 HIV 检测之前提供的一组互动组件（例如，关于以下益处的 PrEP 信息） PrEP），并且在参与者检测出 HIV 阴性并同意开始 PrEP（例如，坚持自我监测）后。目标 1：使用迭代开发流程，通过以下方式获取有关 eSTEP 内容和功能的反馈： GBMSM 和 TW 以及社区咨询委员会 (CAB) 组成的焦点小组 6 个焦点小组，成员人数为 18-45 人。岁 GBMSM 和 TW（6 名参与者/组；> 50% 黑人/拉丁裔）将在 3 个关键点进行干预开发周期，以创建定制的（分别针对 GBMSM 和 TW）IMB 相关内容和 eSTEP 的特征将建立 GBMSM (n=3) 和 TW (n=3) 之间的指导。目标 1 将在 3 个 GBMSM 和 3 个 TW 之间进行可用性测试，以最终确定 eSTEP。目标 2：开展 eSTEP 试点随机对照试验，以评估其可行性、可接受性和 GBMSM 和 TW 之间的初步影响，为大规模 R01（50% 种族/族裔）做准备。报告符合 PrEP 资格的风险因素的 GBMSM (n=85) 和 TW (n=35) 将被随机分配 (2:1) eSTEP 干预 (n=80) 或常规 HIV 检测对照 (n=40)。所有研究参与者都将获得免费的现场艾滋病毒检测。如果符合条件，可以在大学的 HIV 预防和治疗诊所开始进行 PrEP。 PrEP 将解锁 PrEP 依从性和持久性组成部分，后续研究访问将在下午 3 点进行。 6 个月的时间收集生物学、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 依从性和 PrEP 最后，干预组中的 10 名 GBMSM 和 10 名 TW 将参与退出。采访以获得有关 eSTEP 的反馈，以期进行大规模 R01 研究。