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

项目摘要/摘要 这项研究的目标是确定有效的方法和实施战略，以增强年轻人的能力 南非艾滋病毒高危妇女使用和坚持接触前预防(PrEP) 在艾滋病毒感染风险较高的时期进行预防。年轻女性对预科药物的接受率仍然很低 FSW和AGYW的使用量减半1个月，并在前3-6个月继续急剧下降； 需要制定针对这些关键时期的有效战略。这项拟议的研究嵌入了结核病艾滋病毒 CARE现有的大规模PrEP分娩计划，面向南非12个地点的年轻女性。这个 设计利用常规收集的数据与从头开始的数据和修改的战略性收集相结合 提供现有的执行战略，以便有效扩大PrEP的规模。具体目标1： 衡量正在进行的PrEP实施(例如，可接受性、采用率、保真度、成本)并确定实施情况 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、提供者评估、实施日志)，并进行 使用现有计划数据的中断时间序列分析(2016-2020年)和对PrEP遵守情况的更改 随着时间的推移引入干预措施(例如PrEP同行大使、忠诚度奖励计划等)。这些数据 将用于确定计划内有效的PrEP干预措施，并进一步完善PrEP 实施战略。具体目标2：评价改良PrEP的相对有效性 在边缘化人群中增加吸毒率和持续遵守PrEP的实施战略 年轻女性。2A。方法：采用整群随机设计评价PrEP的含量和覆盖范围 社会影响运动及其对PrEP摄取和坚持的影响。2B。方法：开展集群 随机试验侧重于修改现有同伴支持干预的实施战略，以 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。相对的 将比较实现1个月、4个月和7个月遵守的实施战略的有效性，并 通过编程的PrEP重新填充数据进行测量。具体目标3：确定一套首选的PrEP 基于预测的人口层面艾滋病毒预防的年轻妇女执行战略 传输建模和成本效益分析。方法：我们将扩展、重新参数化和 分析我们先前验证的异性传播HIV的确定性数学模型 南部非洲，它捕捉到了PrEP在#年人口中的直接和间接(溢出)预防益处 关注(AGYW和FSW)和更广泛的人口。这将量化人口受益(感染 反)，并将包括全面的经济评估。

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.