Optimizing PrEP implementation and effectiveness among women at high risk for HIV acquisition in South Africa

项目总结/摘要 本研究的目标是确定有效的方法和实施策略来增强年轻人的权能 南非艾滋病毒高危妇女利用并坚持接受艾滋病毒暴露前预防（PrEP） 在艾滋病毒感染风险升高期间进行预防。年轻女性的PrEP摄取率仍然很低 FSW和AGYW的使用量在1个月内减半，并在前3-6个月内继续急剧下降; 需要针对这些关键时期制定有效的战略。拟议的研究是嵌入在结核病艾滋病毒 Care为南非12个地点的年轻女性提供的大规模PrEP交付计划。的 设计利用常规收集的数据，结合重新收集的战略数据和修改 提供现有的实施战略，为有效扩大PrEP规模提供信息。具体目标1： 衡量正在进行的PrEP实施情况（例如，可接受性、采用性、忠实性、成本），并确定实施 与PrEP摄取和持续使用相关的策略。方法：评估正在进行的计划 实施（例如直接观察方法、提供商评估、实施日志）并进行 使用现有项目数据（2016-2020年）和PrEP依从性变化进行中断的时间序列分析 随着时间的推移引入的干预措施（例如PrEP同伴大使，忠诚奖励计划等）。这些数据 将用于在计划中确定有效的PrEP干预措施，并进一步完善PrEP 执行战略。具体目标2：评价改良PrEP的相对有效性 关于提高边缘化人群对PrEP的接受率和持续坚持PrEP的实施战略 年轻女性。2a.方法：使用分组随机设计来评估PrEP的内容和覆盖范围 社会影响运动，及其对PrEP吸收和持久性的影响。2b.方法：进行分组 一项随机试验，重点是修改现有同伴支持干预措施的实施策略， 通过改变实施战略的参与者、强度和持续时间，提高PrEP的持久性。相对 将比较实现1个月、4个月和7个月依从性的实施策略的有效性， 通过程序性PrEP补充数据进行测量。具体目标3：确定一套首选的PrEP 根据预计的人口艾滋病毒预防工作， 传输建模和成本效益分析。方法：我们将扩展，重新参数化， 分析我们以前验证的确定性数学模型的异性恋艾滋病毒传播， 南部非洲，该地区获得了PrEP在以下人群中的直接和间接（溢出）预防效益： 利益（AGYW和FSW）和更广泛的人口。这将量化人口效益（感染 反向）的PrEP实施战略，并将包括一个全面的经济评估。

Project Summary/Abstract The goal of this study is to identify effective approaches and implementation strategies to empower young women at high risk for HIV in South Africa to utilize and persist on pre-exposure prophylaxis (PrEP) for HIV prevention during periods of elevated risk for HIV acquisition. PrEP uptake remains low among young women and use by FSW and AGYW halves by 1 month and continues a sharp decline during the first 3-6 months; effective strategies to target these critical periods are needed. The proposed study is embedded within TB HIV Care’s large-scale existing PrEP delivery program for young women across 12 sites in South Africa. The design leverages routinely collected data combined with strategic collection of de novo data and modifications to the delivery of existing implementation strategies to inform effective PrEP scale-up. Specific Aim 1: Measure ongoing PrEP implementation (e.g., acceptability, adoption, fidelity, cost) and identify implementation strategies associated with PrEP uptake and sustained use. Approach: Assess ongoing program implementation (e.g. direct observation methods, provider assessments, implementation logs) and conduct an interrupted time-series analysis using existing, program data (2016-2020) and changes to PrEP adherence interventions introduced over time (e.g. PrEP peer ambassadors, loyalty rewards program, etc.). These data will be used to identify effective PrEP interventions within the program and to further refine PrEP implementation strategies. Specific Aim 2: Evaluate the relative effectiveness of modified PrEP implementation strategies on increasing uptake and sustained PrEP adherence among marginalized young women. 2a. Approach: Use a cluster randomized design to evaluate the content and reach of PrEP social influence campaign, and its effect on PrEP uptake and persistence. 2b. Approach: Conduct a cluster randomized trial focused on modifying implementation strategies of existing peer support interventions to improve PrEP persistence, by varying the actor, intensity and duration of the implementation strategy. Relative effectiveness of implementation strategies at achieving 1, 4 and 7-month adherence will be compared and measured through programmatic PrEP refill data. Specific Aim 3: Identify a set of preferred PrEP implementation strategies for young women based on the projected population-level HIV prevention transmission modeling and cost-effectiveness analyses. Approach: We will extend, re-parameterize, and analyze our previously validated deterministic mathematical model of heterosexual HIV transmission in Southern Africa, which captures direct and indirect (spillover) prevention benefits of PrEP in the population of interest (AGYW and FSW) and the wider population. This will quantify the population benefits (infections inverted) of the PrEP implementation strategies and will include a full economic evaluation.