PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM

PrEP2Prevent：YMSM 的在线 PrEP 导航和激活干预

• 批准号: 10231214
• 负责人: Lisa B Hightow-Weidman
• 金额: $ 27.95万
• 依托单位: CHILDREN'S HOSPITAL OF LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10231214
• 关键词: Address; Adoption; Anti-Retroviral Agents; Belief; Biological Markers; Caring; Centers for Disease Control and Prevention (U.S.); Complex; Data; Development; Ensure; Epidemic; Focus Groups; Future; Goals; HIV; HIV Seropositivity; Health Services Accessibility; Hearing; Homophobia; Incidence; Individual; Intention; Intervention; Knowledge; Latino; Maintenance; Measures; Mental Depression; Participant; Patients; Persons; Pharmaceutical Preparations; Population; Populations at Risk; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reporting; Research; Resources; Risk; Sampling; Self Efficacy; Services; Sexually Transmitted Diseases; Social support; Source; Structure; Surveys; Technology; Testing; Text; Time; United States; United States Dept. of Health and Human Services; Videoconferencing; Youth; acceptability and feasibility; antiretroviral therapy; base; behavioral outcome; care providers; cohort; cost; efficacy evaluation; ethnic diversity; experience; implementation research; innovation; intervention effect; mHealth; men' s group; peer; pre-exposure prophylaxis; prevent; primary outcome; racial and ethnic; recruit; response; service engagement; skills; social culture; social stigma; social structure; standard of care; substance use; success; therapy development; tool; trend; uptake; usability; virtual intervention; young men who have sex with men

This is a revised (A1) R34 application entitled, PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, which proposes to develop and pilot test a PrEP activation, navigation and support intervention for young men who have sex with men (YMSM). This population has the highest annual incidence of HIV and is also the least likely to have ever used PrEP. Our own data with a large cohort of YMSM indicates that while 90% have heard about PrEP and 86% meet CDC’s eligible criteria for PrEP, only 23% have ever used PrEP and 8% are currently on PrEP. In this same cohort, 26% tested positive for one or more sexually transmitted infections (STIs) and the HIV seroconversion rate was 4.3% during a 2 years period. Thus, it is very clear that there is an urgent need for interventions that specifically target PrEP uptake while also addressing a complex array of individual (e.g. substance use, depression), sociocultural (e.g., PrEP- related stigma), and structural (e.g., medication costs) barriers to PrEP uptake. Based on our own research, we are proposing an intervention that includes PrEP navigation; patient activation to reduce PrEP-related stigma and increase PrEP self-efficacy; and peer/social support. The intervention will be delivered using mobile health (mHealth) or similar technology. The specific aims are to: 1) Conduct formative research to inform the development of a PrEP activation, navigation and support intervention, which we call PrEP2Prevent. Qualitative working/focus group data will be collected from YMSM and focus groups will be conducted with PrEP care providers/navigators; 2) Develop and then conduct usability testing of PrEP2Prevent, including both the intervention content and mHealth delivery platform; and 3) Evaluate the feasibility and acceptability of PrEP2Prevent with a racially/ethnically diverse sample of 150 YMSM (ages 16-24 years). Participants will be randomly as assigned to the intervention (PrEP2Prevent) or control (standard of care) group. Primary outcomes are feasibility and acceptability. A secondary aim is to evaluate the impact of the intervention on our targeted meditating mechanisms and proximal behavioral outcomes (e.g., PrEP stigma and self- efficacy). We will also assess participants’ PrEP uptake (using verified service use and a biomarker of PrEP use) to determine if there are any trends associated with participation in the intervention. Assessments will occur at baseline and at 3- (intervention completion) and 6-months. These data will provide estimates of possible intervention effect sizes (group means, SDs) for a future RCT. Implementation research will also be conducted, drawing upon the RE-AIM framework. The proposed research is highly significant, timely and innovative. It targets an intervention for YMSM where they need it most — i.e., on PrEP uptake. It recognizes that YMSM require tools and support to successfully navigate PrEP services, and uses mHealth to deliver the intervention. Moreover, the intervention can be used to both engage and re-engage YMSM in PrEP uptake, and it can potentially be adapted to address uptake of long-acting PrEP and antiretroviral therapy (ART).

这是修订版 (A1) R34 应用程序，标题为 PrEP2Prevent：在线 PrEP 导航和激活 YMSM 的干预措施，建议开发和试点测试 PrEP 激活、导航和支持 对男男性行为者 (YMSM) 的干预 该人群的年发病率最高。 HIV 感染者，也是使用过 PrEP 的可能性最小的人。 表明虽然 9​​0% 的人听说过 PrEP 并且 86% 的人符合 CDC 的 PrEP 合格标准，但只有 23% 曾经使用过 PrEP，8% 目前正在使用 PrEP 在同一队列中，26% 的人的一项或多项检测结果呈阳性。 2 年内，性传播感染 (STI) 和 HIV 血清转化率为 4.3%。 因此，很明显，迫切需要专门针对 PrEP 摄取的干预措施，同时 还涉及一系列复杂的个人问题（例如药物滥用、抑郁症）、社会文化问题（例如 PrEP- 根据我们自己的研究，相关耻辱）和结构性（例如药物费用）障碍。 我们建议采取包括 PrEP 导航在内的干预措施，以减少与 PrEP 相关的情况； 耻辱并提高 PrEP 自我效能；以及同伴/社会支持将通过移动设备进行。 健康 (mHealth) 或类似技术的具体目标是： 1) 进行形成性研究，为人们提供信息。 开发 PrEP 激活、导航和支持干预措施，我们称之为 PrEP2Prevent。 定性工作/焦点小组数据将从 YMSM 收集，焦点小组将与 PrEP 护理提供者/导航者；2) 开发 PrEP2Prevent，然后进行可用性测试，包括两者 干预内容和移动医疗交付平台；以及 3) 评估可行性和可接受性 PrEP2Prevent 的参与者包括 150 名 YMSM（年龄 16-24 岁）。 随机分配至干预组 (PrEP2Prevent) 或对照组（标准护理）。 结果是可行性和可接受性。第二个目的是评估干预措施的影响。 我们有针对性的冥想机制和近端行为结果（例如，PrEP 耻辱和自我 我们还将评估参与者的 PrEP 吸收情况（使用经过验证的服务使用情况和 PrEP 生物标志物）。 使用）来确定是否存在与参与干预相关的任何趋势。 发生在基线以及 3 个月（干预完成）和 6 个月时。这些数据将提供估计值。 未来随机对照试验实施研究的可能干预效果大小（组均值，SD）也将是。 所提出的研究非常重要、及时且有效。 它的目标是在 YMSM 最需要的地方进行干预——即 PrEP 的采用。 YMSM 需要工具和支持来成功导航 PrEP 服务，并使用 mHealth 来提供 此外，干预措施可用于吸引和重新吸引 YMSM 参与 PrEP 的吸收， 它有可能适用于解决长效 PrEP 和抗逆转录病毒治疗 (ART) 的问题。