PrEP Seguro: Antiretrovial-based HIV prevention among men at high risk in Mexico

摘要 依从性对于暴露前预防（PrEP）减少艾滋病毒传播的有效性至关重要。 男性性工作者（MSW），向其他男性出售性服务的男性，可以从PrEP中受益，因为他们处于高风险状态 艾滋病毒的获得和传播。然而，他们很难坚持每天服用药丸，因为他们 通常对风险认识不足，对新的预防工具了解有限， 预防服务。我们的长期目标是推进PrEP的实施，以降低艾滋病毒的发病率。 在低收入和中等收入国家（LMIC）的关键人群中。此R34应用程序的目标是 准备测试以用户为中心的创新方法，以促进PrEP的大规模遵守。我们的核心假设 如果PrEP与高度定制的PrEP一起沿着免费提供， 有条件经济激励（CEI）。具体目标是： 目的1：完善以用户为中心的条件性PrEP依从性干预设计 经济激励，以最大限度地提高持续的遵守行为，通过用户响应 计算机化调查（n=200）。我们通过用户将定量识别的偏好纳入CEI- 响应式计算机化调查。我们使用联合分析来了解CEI干预的偏好 这些问题包括如何将CEI集成到目标2中测试的最佳组合包中。 目标2：衡量以用户为中心的CEI干预在多大程度上可以帮助MSW增加其 在随机对照试验中坚持使用免费PrEP（n=100）。在接受免费取用的都市固体废物中， PrEP，并在第1个月返回第二个药瓶，我们将n=100 MSW随机分配至以下任一组：标准治疗 (SoC：信息、处方、免费PrEP）或CEI（SoC +奖励，取决于高依从性 PrEP）。我们将在3个月时评估主要结局（使用头皮毛发分析的依从性生物标志物） 和6，以及次要结果：门诊出勤/保留，药物拥有率，自我报告 PrEP使用和性行为解除抑制（伴侣数量，避孕套使用，STI事件）。 目标3：估计PrEP依从性激励措施的初步成本效益， 这一有希望的干预战略的未来政策和实践相关性。我们的假设是 有条件的经济激励PrEP依从性将具有成本效益的成本方面，每完全- PrEP依从月数、避免的每例艾滋病毒感染成本以及节省的每残疾调整生命年成本 与未接受有条件激励的对照组相比。 这个R34的预期结果是一个示范，是可行的，以实现以用户为中心的CEI在这 背景，以及初步的功效和成本效益数据。该项目将产生积极影响 因为这是在高危人群中扩大PrEP实施的关键一步 在墨西哥，这对世界各地城市固体废物中的其他集中流行病有影响。

ABSTRACT Adherence is essential for the effectiveness of pre-exposure prophylaxis (PrEP) in reducing HIV transmission. Male sex workers (MSW), men who sell sex to other men, can benefit from PrEP because they are at high risk of HIV acquisition and transmission. However, they have difficulties adhering to a daily pill because they commonly have low awareness of their risk and limited knowledge of new prevention tools, and face barriers to access prevention services. Our long-term goal is to advance implementation of PrEP to reduce HIV incidence in key populations in low- and middle-income countries (LMICs). The objective of this R34 application is to prepare for testing innovative user-centered ways to promote PrEP adherence at scale. Our central hypothesis is that adherence to PrEP can be improved among MSW if PrEP is provided for free along with highly-tailored conditional economic incentives (CEI). The specific aims are: Aim 1: To refine the design of PrEP adherence intervention with user-centered conditional economic incentives to maximize sustained adherence behaviors through a user-responsive computerized survey (n=200). We incorporate quantitatively identified preferences for CEIs through a user- responsive computerized survey. We use conjoint analysis to understand preferences for CEI intervention components and how CEIs should be integrated into an optimal combination package to be tested in Aim 2. Aim 2: Measure the extent to which a user-centered CEI intervention can help MSW increase their adherence to free PrEP in a randomized controlled pilot (n=100). Among MSW who accept to take free PrEP, and return at month 1 for a second pill bottle, we will randomize n=100 MSW to either: standard of care (SoC: information, prescription, free PrEP) or CEI (SoC + incentives contingent on sufficiently-high adherence to PrEP). We will assess the primary outcome (biomarker of adherence using scalp hair analysis) at months 3 and 6, as well as secondary outcomes: clinic attendance/retention, medication possession ratio, self-reported PrEP use, and sexual behavioral disinhibition (number of partners, condom use, incident STI). Aim 3: Estimate the preliminary cost-effectiveness of incentives for PrEP adherence to maximize future policy and practice relevance of this promising intervention strategy. Our working hypothesis is that conditional economic incentives for PrEP adherence will be cost-effective in terms of cost per fully- adherent month on PrEP, cost per HIV infection averted, and cost per disability-adjusted life year saved when compared to controls not receiving the conditional incentives. The expected outcome of this R34 is a demonstration that is feasible to implement user-centered CEIs in this context, as well as preliminary efficacy and cost-effectiveness data. The project will have positive impact because it is a critical step toward scaled-up implementation of PrEP in this highly-at-risk population of MSWs in Mexico, with implications for other concentrated epidemics among MSW worldwide.