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

优化南非艾滋病毒感染高风险女性的 PrEP 实施和有效性

• 批准号: 10238808
• 负责人: Sheree Renae Schwartz
• 金额: $ 63.91万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-14 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10238808
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Adherence; Adoption; Advertising; Age; Awareness; Behavioral; Biological; Caring; Cluster randomized trial; Collection; Communities; Cost Effectiveness Analysis; Country; Couples; Data; Effectiveness; Epidemic; Epidemiologist; Family; Female Adolescents; Friends; Funding; Generations; Goals; Government; HIV; HIV risk; HIV/TB; Health; Health Personnel; Health Status; Heterosexuals; High Risk Woman; Human immunodeficiency virus test; Incidence; Individual; Infection; Infrastructure; Interruption; Intervention; Mathematics; Measures; Methods; Modeling; Modification; Nonprofit Organizations; Outcome; Pharmaceutical Preparations; Population; Prevention; Provider; Province; Randomized; Research Design; Rewards; Risk; Scientist; Self Efficacy; Site; Social support; South Africa; South African; Southern Africa; Structure; Time; Time Series Analysis; Validation; Woman; Work; aged; base; condoms; cost; cost effectiveness; critical period; design; economic evaluation; experience; female sex worker; health literacy; high risk; implementation outcomes; implementation science; implementation strategy; improved; interest; mathematical model; multiphase optimization strategy; peer; peer support; pre-exposure prophylaxis; prevent; programs; recruit; relative cost; relative effectiveness; response; scale up; sexual risk behavior; side effect; social; social media; social stigma; tool; transmission process; uptake; young woman

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.

项目概要/摘要 本研究的目的是确定有效的方法和实施策略，以增强年轻人的能力 南非艾滋病毒高危女性应利用并坚持艾滋病毒暴露前预防 (PrEP) 年轻女性感染艾滋病毒风险较高期间的预防措施仍然较低。 FSW 和 AGYW 的使用量减少了 1 个月，并在前 3-6 个月继续急剧下降； 需要针对这些关键时期采取有效的策略。拟议的研究嵌入到结核病艾滋病毒中。 Care 在南非 12 个地点为年轻女性提供大规模的 PrEP 服务。 设计利用常规收集的数据以及从头开始数据和修改的战略收集 落实现有战略，为有效扩大 PrEP 规模提供信息。 具体目标 1： 衡量持续的 PrEP 实施（例如可接受性、采用性、保真度、成本）并确定实施情况 与 PrEP 吸收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（2016-2020）进行中断时间序列分析以及 PrEP 依从性的变化 随着时间的推移引入的干预措施（例如 PrEP 同伴大使、忠诚度奖励计划等）。 将用于确定计划内有效的 PrEP 干预措施并进一步完善 PrEP 具体目标 2：评估修改后的 PrEP 的相对有效性。 提高无家可归者的接受率和持续坚持 PrEP 的实施策略 2a. 方法：使用整群随机设计来评估 PrEP 的内容和范围。 社会影响力活动及其对 PrEP 吸收和持久性的影响 方法：开展集群活动。 随机试验的重点是修改现有同伴支持干预措施的实施策略，以 通过改变实施策略的参与者、强度和持续时间来提高 PrEP 的持久性。 将比较实施策略在实现 1、4 和 7 个月坚持时的有效性 通过程序化 PrEP 补充数据进行测量 具体目标 3：确定一组首选 PrEP。 根据预测的人口层面艾滋病毒预防制定针对年轻妇女的实施战略 传输建模和成本效益分析：我们将扩展、重新参数化和 分析我们之前验证的异性 HIV 传播的确定性数学模型 南部非洲，该地区人口获得了 PrEP 的直接和间接（溢出）预防效益 利益（AGYW 和 FSW）和更广泛的人群 这将量化人群利益（感染）。 PrEP 实施策略的倒置），并将包括全面的经济评估。