Predicting PrEP Uptake and Adherence among Adolescent Girls and Young Women in Sub-Saharan Africa: Leveraging Programmatic and Clinical Trials Data

摘要 总体而言，全世界15%的艾滋病毒携带者年龄在15-24岁之间，其中大多数(80%)生活在亚 撒哈拉非洲。尽管艾滋病毒护理和治疗倡议以及预防活动的扩大 撒哈拉以南非洲(SSA)大部分地区的艾滋病毒感染率大幅下降，那里的年轻女性经历了 是世界上艾滋病毒发病率最高的国家之一。最近的研究已经证明了几种药物的疗效 通过减少艾滋病毒感染来降低青春期女孩和年轻妇女感染艾滋病毒风险的干预措施 通过男性包皮环切术或通过早期抗逆转录病毒治疗减少艾滋病毒感染男性的传播 治疗(ART)。AGYW本身的干预措施包括生物医学干预，如抗逆转录病毒治疗- 使用杀微生物剂或暴露前预防，以及包括安全空间在内的社会保护干预措施， 现金转账用于留校、生活技能培训和社区对性别规范变化的支持。 因为没有单一的生物医学、行为或结构干预对AGYW非常有效，大多数 有效的方法可能需要多种干预措施相结合。组合的成功 预防干预措施不仅取决于其组成部分的效力，而且取决于可行性。 广泛实施和个别组成部分的可接受性，这反过来又影响吸收和 坚持不懈。计划实施者面临的一个挑战是从临床试验到计划实施的桥梁 由于试验人群不同于AGYW的总体人群--因此来自试验参与者的数据 可能无法预测真实世界的可接受性以及个人、提供商和社区属性对 AGYW对艾滋病毒预防战略的采纳和坚持。另一个挑战是编程数据 通常不是由假设驱动的，并且在研究设计、数据方面不保持同样的研究严谨性 收集和注释，随机临床试验所做的。因此，仅依靠节目数据进行多层次 因子分析极有可能产生有偏见的结果。在此应用程序中，我们解决了以下挑战 分析多种因素对AGYW吸收和依从性的影响 在撒哈拉以南非洲AGYW的DREAMS倡议计划和临床试验。我们的具体目标是： 目标1.确定与PrEP摄取有关的多层次个人和社区风险因素 AGYW的坚持成果，使用DREAMS倡议的方案数据。 目的2.加强对已确定的影响AGYW吸收和依从性因素的多层次分析 目标1，利用DREAMS倡议和HPTN随机临床试验的数据。 目的3.预测多层次因素对AGYW吸收和坚持HIV预防的影响 并评估其对人口的影响。 目的4.评估组合的随机临床试验和实施研究之间的桥梁 为AGYW的吸收和坚持提供更高精确度的预防干预方案。

ABSTRACT Overall, 15% of women living with HIV worldwide are aged 15-24 years, with the majority (80%) living in sub- Saharan Africa. Although HIV care and treatment initiatives as well as scale-up of prevention activities have dramatically reduced HIV infection rates in much of sub-Saharan Africa (SSA), young women there experience among the highest HIV incidence rates in the world. Recent research has demonstrated the efficacy of several interventions to reduce risk of HIV in adolescent girls and young women (AGYW) by reducing HIV acquisition in men through male circumcision or reducing transmission from HIV-infected men through early antiretroviral therapy (ART). Interventions for AGYW themselves have included biomedical interventions such as ART- based microbicides or pre-exposure prophylaxis, and social protection interventions including safe spaces, cash transfers for staying in school, life skills training, and community support for changes in gender norms. Because no single biomedical, behavioral or structural intervention is highly effective for AGYW, the most effective approach will likely involve multiple interventions in combination. The success of combination prevention interventions will depend not only on the efficacy of their component parts but also on the feasibility of broad implementation and the acceptability of individual components which, in turn, affect uptake and adherence. One challenge for program implementers is bridging from clinical trials to program implementation since the trial populations are different from the overall population of AGYW – thus data from trial participants may not predict real-world acceptability and the influence of individual, provider and community attributes on AGYW’s uptake of and adherence to HIV prevention strategies. An additional challenge is programmatic data are usually are not hypothesis-driven, and do not maintain the same research rigor in study design, data collection and annotation, that randomized clinical trials do. Thus, relying on program data alone for multi-level factor analysis is highly likely to produce biased results. In this application, we tackle the challenges of analyzing the influence of multiple factors on AGYW’s uptake and adherence leveraging data from both the DREAMS Initiative program and clinical trials in sub-Saharan African AGYW. Our specific aims are: Aim 1. Determine multi-level individual and community risk factors associated with the PrEP uptake and adherence outcomes among AGYW, using programmatic data from the DREAMS Initiative. Aim 2. Enhance multi-level analysis of the factors identified to influence uptake and adherence by AGYW in Aim 1, leveraging data from both the DREAMS Initiative and the HPTN randomized clinical trials. Aim 3. Predict the influence of the multi-level factors on AGYW uptake and adherence to HIV prevention packages, and assess their population impact. Aim 4. Bridge between the randomized clinical trials and the implementation studies to assess combination prevention intervention packages with better precision for AGYW’s uptake and adherence.