Peer Navigation to Improve Engagement in Care for HIV-Positive MSM in South Africa

 描述(由申请人提供)：南非男男性行为者(MSM)艾滋病毒阳性男子不是最佳的艾滋病毒护理对象。在姆普马兰加省Ehlanzeni区农村的男男性接触者社区，那里的流行率估计为23%，发病率接近每100人年30人，只有不到10%的艾滋病毒阳性男男性接触者从事护理或接受抗逆转录病毒治疗。缩小男男性接触者的治疗需求和吸入率之间的巨大差距至关重要，因为南非正在实施2015年的指导方针，在CD4500推荐抗逆转录病毒治疗。迫切需要有针对性的干预方法，以提高艾滋病毒阳性男男性行为者的护理参与度，但目前还没有可以规模化的经证实有效的干预措施。患者导航策略，特别是同行导航(PN)，已经在多个背景下实施，并为多个人群量身定做，并在改善艾滋病毒连续护理结果方面显示出希望，包括参与、保留、对ART的坚持和病毒抑制。为了应对南非男男性接触者这种干预的迫切需求，我们提议进行研究，以适应、手册和实施南非男男性接触者的PN干预模式(目标1)，评估对Ehlanzeni区100名HIV阳性MSM进行PN干预的可行性和可接受性(目标2)，并通过比较这100名MSM和50名HIV阳性MSM接受临床治疗的连续护理结果，为未来的PN干预的全面、多地点疗效试验做准备(目标3)。我们将在两个阶段实现这些目标：1)系统的、定性的干预适应研究，2)MSM随机分配到PN或标准护理条件下的试点随机对照试验。我们将利用NIAID赞助的姆普马兰加男性研究(R01AI089292，Lane)、NIMH赞助的HIV自我检测研究(R21MH103038，Lippman)以及PEPFAR赞助的普通人群客户同行导航试验(Current Control Trials NCT02417233)期间开发的结果和基础设施来开展拟议的研究。我们假设，对于HIV阳性的MSM来说，PN干预将是可行和可接受的；那些随机接受PN的人在参与度、保留率、依从性和病毒抑制方面将比在护理标准组中表现出更大的改善；可行和可接受的PN干预可能与其他预防方法相结合，这些方法最终将显示出降低这一高负担关键人群发病率所必需的连续护理指标的社区水平影响。

 DESCRIPTION (provided by applicant): HIV-positive men who have sex with men (MSM) in South Africa are not optimally engaged in HIV care. In MSM communities in rural Ehlanzeni district of Mpumalanga province, where prevalence is estimated at 23% and incidence at nearly 30 per 100 person-years, less than 10% of HIV-positive MSM are engaged in care or taking ART. Closing the substantial gap between treatment need and uptake among MSM is critical as South Africa implements 2015 guidelines recommending ART at CD4<500. Targeted intervention approaches to improve HIV-positive MSM's engagement in care are urgently needed, yet there are presently no interventions of proven efficacy that can be taken to scale. Patient navigation strategies, particularly peer navigation (PN), have been implemented in multiple contexts and tailored to multiple populations, and show promise in improving HIV continuum of care outcomes, including engagement, retention, ART adherence, and viral suppression. To address the urgent need for such an intervention for South African MSM, we propose research to adapt, manualize, and implement a PN intervention model for South African MSM (Aim 1), to assess the feasibility and acceptability of the PN intervention with 100 HIV-positive MSM in Ehlanzeni district (Aim 2), and to prepare for a future full-scale, multi-site efficacy trial of the PN intervention by comparing continuum of care outcomes of those 100 MSM to 50 HIV-positive MSM receiving standard referrals to clinical care (Aim 3). We will achieve these aims in two phases: 1) systematic, qualitative intervention adaptation research, and 2) a pilot randomized controlled trial of MSM randomly assigned to PN or standard-of-care conditions. We will leverage findings and infrastructure developed during the NIAID-sponsored Mpumalanga Men's Study (R01AI089292, Lane), an NIMH-sponsored HIV Self-Testing Study (R21MH103038, Lippman), and a PEPFAR-sponsored trial of peer navigation among general population clients (Current Controlled Trials NCT02417233) to carry out the proposed research. We hypothesize that the PN intervention will be feasible and acceptable to HIV-positive MSM; that those randomized to PN will show greater improvements in engagement, retention, adherence, and viral suppression compared to those in the standard-of-care; and that a feasible and acceptable PN intervention may be combined with other prevention approaches that will ultimately show the community-level effects across the continuum-of-care indicators necessary to reduce incidence in this high-burden key population.