Provider and Peer Support Intervention to Improve ART Adherence among Kenyan Men

描述(由申请人提供)：尽管男男性行为者(MSM)在全球范围内感染艾滋病毒的风险非常高，但这一群体最近才成为撒哈拉以南非洲国家艾滋病毒/艾滋病项目的重要重点。虽然抗逆转录病毒疗法(ART)显然可以减少艾滋病相关的发病率和死亡率，并防止艾滋病毒感染的男男性接触者的性传播，但对非洲男男性接触者中的抗逆转录病毒依从性和护理障碍知之甚少。自2005年以来，我们一直在肯尼亚海岸与涉及性工作的男男性接触者合作，发现这一群体在艾滋病毒治疗参与度、抗逆转录病毒治疗依从性和临床结果方面存在显著差异，至少部分原因是耻辱和社会孤立。让BOT提供者和同行参与干预，在MSM发起抗逆转录病毒治疗时支持他们，并结合定期信息传递以促进遵守，是解决这一治疗缺口的创新战略。在这份R34申请中，根据PAR-11-278“发现、开发和测试推进艾滋病毒预防和护理的新干预措施”，我们提出了一个为期3年的开发项目，以设计和试点测试一种文化上合适的、可推广的非洲MSM抗逆转录病毒依从性干预措施。该项目是华盛顿大学、肯尼亚医学研究所、牛津大学和布朗大学经验丰富的研究人员之间的多学科合作，基于7年来与肯尼亚MSM进行研究的基础，这些经验支持了这项建议的意义和创新。我们的具体目标是：(1)对HIV-1血清阳性的MSM、有治疗经验的同龄人及其提供者进行包括深入访谈和焦点小组在内的定性研究，以确定共同的障碍和可能的ART依从性促进者；(2)设计并现场测试结合提供者和同伴支持的MSM理论驱动的干预措施，以鼓励参与护理，建立信任，并提供定期依从性信息；以及(3)对产生的多成分干预与标准护理进行试点随机对照试验(RCT)，共有60名MSM参与者。我们将开发用于干预的培训模块和支持材料，包括以患者为中心的护理、激励性访谈、同行支持和遵守信息，以适应我们定性研究的具体结果。这项拟议的研究符合美国国立卫生研究院艾滋病研究办公室关于减少艾滋病毒相关差异和改善艾滋病毒感染者疾病结局的优先事项，也符合2011年医学研究所关于女同性恋者、男同性恋者、双性恋者和变性人的健康报告中提出的建议，以实施旨在促进对LGBT健康的了解和理解的研究议程。这项R34形成研究的结果将提供有关可行性、可接受性、耐受性、安全性和初步效果大小的数据，或R01提案，以在全功率随机对照试验中测试这种干预及其组成部分，包括来自撒哈拉以南非洲多个地点的更大、更多样化的男男性接触者样本。

DESCRIPTION (provided by applicant): Although men who have sex with men (MSM) are at very high risk for HIV globally, this group has only recently become an important focus of national HIV/AIDS programs in sub-Saharan Africa. While it is clear that antiretroviral therapy (ART) can reduce AIDS-related morbidity and mortality and prevent sexual transmission from HIV-infected MSM, little is known about antiretroviral adherence and barriers to care among African MSM. We have worked with MSM involved in sex work on the Kenyan coast since 2005, and have found significant disparities in HIV treatment engagement, ART adherence, and clinical outcomes in this group, due at least in part to stigma and social isolation. Involving bot providers and peers in an intervention to support MSM as they initiate ART, combined with regular messaging to promote adherence, is an innovative strategy to address this treatment gap. In this R34 application, prepared in response to PAR-11-278 "Discovery, Development, and Testing of Novel Interventions to Advance HIV Prevention and Care," we propose a 3-year developmental project to design and pilot test a culturally appropriate and generalizable antiretroviral adherence intervention for African MSM. The project is a multidisciplinary collaboration among experienced investigators at the University of Washington, Kenya Medical Research Institute, University of Oxford, and Brown University, based on a foundation of 7 years' experience conducting research with Kenyan MSM that underpins the significance and innovation of this proposal. Our specific aims are to: (1) conduct qualitative research including in-depth interviews and focus groups with HIV-1-seropositive MSM, treatment-experienced peers, and their providers to identify common barriers and likely facilitators of ART adherence; (2) design and field test a theoretically driven intervention for MSM combining provider and peer support to encourage engagement in care, build trust, and deliver regular adherence messaging; and (3) implement a pilot randomized controlled trial (RCT) of the resulting multi-component intervention versus standard care with 60 MSM participants. We will develop training modules and supporting materials for an intervention including patient-centered care, motivational interviewing, peer support, and adherence messaging adapted to the specific findings of our qualitative study. The proposed research is consistent with and responds to priorities set by the NIH Office of AIDS Research on reducing HIV-related disparities and improving disease outcomes for HIV-infected individuals, and is also consistent with the recommendation set forth in the 2011 Institute of Medicine report on The Health of Lesbian, Gay, Bisexual, and Transgender People to implement a research agenda designed to advance knowledge and understanding of LGBT health. Findings from this formative R34 study will provide data on the feasibility, acceptability, tolerability, safety, and preliminary effect sizes or an R01 proposal to test this intervention and its components in a fully powered RCT including a larger, more diverse sample of MSM from multiple sites in sub-Saharan Africa.