Shikamana PrEP: A Community Participatory Approach to Integrating PrEP, Sexual Health, and Mental Health Services for GBMSM in Kenya

项目摘要 男同性恋、双性恋和其他男男性行为者(GBMSM)感染HIV-1的风险很高， 特别是在权利受限的情况下，如肯尼亚，男子获得艾滋病毒预防的机会 受到同性恋恐惧症、耻辱和歧视的阻碍。暴露前预防(PrEP)有可能 极大地降低这一关键人群的艾滋病毒感染风险，如果可以获得可持续的PrEP规划， 可以提供量身定制的、有效的遵从性支持。为此，PrEP计划之间密切合作 实施者和GBMSM领导的以社区为基础的组织至关重要。在此R34应用程序中，我们 建议(1)确定影响GBMSM参与PrEP的能力的多层次障碍和促进者 通过检查影响肯尼亚GBMSM生活的社会生态因素，包括性 和PrEP相关的耻辱、性健康促进和复原力，通过与PrEP的定性工作- 从事艾滋病毒检测/咨询或PrEP规划的有经验和幼稚的GBMSM和同龄人；(2) 适应和加强称为Shikamana的基于理论和文化相关的PrEP支持干预 准备工作，包括同伴导航和综合“下一步咨询”，以促进性健康保护 战略，包括PrEP的吸收和遵守，在基苏木的GBMSM中，遵循以下步骤1-6 适应--ITT模式(评估、决策、适应、产生、专家审查和综合 反馈)与我们的GBMSM社区合作伙伴合作；以及(3)为了确定可接受性， Shikamana PrEP干预的可行性和安全性，并与标准比较估计初始效应大小 护理对PrEP摄取和依从性的影响，根据6个月内的药物水平进行评估 审判。这项建议建立在Shikamana研究的成功基础上，该研究开发了一个提供者和同行 成功增加HIV阳性患者血浆病毒载量抑制几率的支持干预 GBMSM接受抗逆转录病毒治疗，以及Anza Mapema项目，该项目招募了600多名艾滋病毒阴性者 在基苏木的GBMSM在艾滋病毒预防服务中进行了12个月的跟踪，目前正在进行PrEP 对167名男性进行为期12个月的队列调查。我们经验丰富、富有成效的多学科合作团队来自 华盛顿大学、密歇根大学和Nyanza生殖健康协会拥有专业知识 在艾滋病毒预防和护理领域(格雷厄姆、奥蒂诺和贝利博士)和行为科学以及 干预设计(Graham，Harper，Amico和Simoni博士)，并与 由研究区域内23个社区LGBTI组织组成的NYARWEK网络。我们期待着这一结果 通过确保GBMSM参与有效的 为肯尼亚的这一关键人群制定PREP方案，并为GBMSM提供同行主导的PrEP支持模式 以及非洲环境中的其他弱势和边缘化人口。

Project Summary Gay, bisexual, and other men who have sex with men (GBMSM) are at high risk for HIV-1 acquisition, especially in rights-constrained settings such as Kenya, where men's access to HIV prevention has been impeded by homophobia, stigma, and discrimination. Pre-exposure prophylaxis (PrEP) has the potential to greatly reduce HIV acquisition risk in this key population, if accessible, sustainable PrEP programming with tailored, effective adherence support can be provided. To this end, close collaboration between PrEP program implementers and GBMSM-led community-based organizations is essential. In this R34 application, we propose (1) to identify multi-level barriers and facilitators that influence GBMSM's ability to engage in the PrEP continuum of care by examining socioecological factors that impact Kenyan GBMSM's lives, including sexual and PrEP-related stigma, sexual health promotion, and resilience, through qualitative work with PrEP- experienced and PrEP-naïve GBMSM and peers engaged in HIV testing/counseling or PrEP programming; (2) to adapt and enhance a theory-based and culturally relevant PrEP support intervention called Shikamana PrEP that includes peer navigation and integrated “Next Step Counseling” to promote sexual health protection strategies, including PrEP uptake and adherence, among GBMSM in Kisumu, following steps 1-6 of the ADAPT-ITT model (assessment, decision-making, adaptation, production, expert review, and integration of feedback) in collaboration with our GBMSM community partners; and (3) to determine the acceptability, feasibility, and safety of the Shikamana PrEP intervention and estimate initial effect size compared to standard of care on PrEP uptake and adherence assessed by drug levels over 6 months in a pilot randomized controlled trial. This proposal builds on the success of the Shikamana study, which developed a provider and peer support intervention that successfully increased the odds of plasma viral load suppression among HIV-positive GBMSM taking antiretroviral therapy, and the Anza Mapema project, which enrolled over 600 HIV-negative GBMSM in Kisumu for 12 months of follow-up in HIV prevention services and is currently following a PrEP cohort of 167 men for 12 months. Our experienced, productive multidisciplinary team of collaborators from the University of Washington, University of Michigan, and the Nyanza Reproductive Health Society, has expertise in the fields of HIV prevention and care (Drs. Graham, Otieno, and Bailey) and behavioral science and intervention design (Drs. Graham, Harper, Amico, and Simoni), and has partnered for this research with the NYARWEK Network of 23 community-based LGBTI organizations in the study area. We anticipate that results of the proposed research will have high impact by ensuring GBMSM involvement in the scale-up of effective PrEP programming for this key population in Kenya and providing a peer-led PrEP support model for GBMSM and other vulnerable and marginalized populations in African settings.