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

预测撒哈拉以南非洲地区青春期女孩和年轻女性的 PrEP 吸收率和依从性：利用计划和临床试验数据

• 批准号: 10201694
• 负责人: Ying Qing Chen
• 金额: $ 11.88万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10201694
• 关键词: AIDS prevention; Address; Adherence; Affect; Africa; Africa South of the Sahara; African; Age; Behavioral; Caring; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Communities; County; Data; Data Collection; Dose; Drug Kinetics; Epidemic; Exclusion Criteria; Factor Analysis; Family; Female Adolescents; Funding Opportunities; Future; Gender; HIV; HIV Infections; HIV prevention trials network; Health; Health Personnel; Incidence; Individual; Intervention; Interview; Kenya; Life; Male Circumcision; Measurement; Mentors; Methods; Modeling; Monitor; Oral; Outcome; Participant; Population; Prevention; Prevention approach; Prevention program; Prevention strategy; Prevention trial; Preventive; Provider; Randomized; Randomized Clinical Trials; Regimen; Research; Research Design; Risk; Risk Factors; Role; Sahara; Sampling Biases; Schools; Sexual Partners; Social Protection; South Africa; Structure; Time; Vulnerable Populations; Weight; Woman; Zambia; aged; antiretroviral therapy; base; clinical trial implementation; condoms; cost effectiveness; design; empowered; experience; falls; high risk; implementation study; improved; infection rate; infection risk; insight; intervention program; mathematical model; men; microbicide; multi-component intervention; multilevel analysis; peer; pre-exposure prophylaxis; preventive intervention; programs; response; scale up; skills training; success; transmission process; uptake; young woman

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.

摘要 总的来说，全世界15%的艾滋病毒感染妇女年龄在15 - 24岁之间，其中大多数（80%）生活在15岁以下。 撒哈拉非洲。尽管艾滋病毒护理和治疗举措以及预防活动的扩大， 在撒哈拉以南非洲（SSA）的大部分地区，艾滋病毒感染率急剧下降，那里的年轻妇女经历了 是世界上艾滋病发病率最高的国家之一。最近的研究表明， 通过减少艾滋病毒感染，降低少女和年轻妇女感染艾滋病毒风险的干预措施 或通过早期抗逆转录病毒治疗减少艾滋病毒感染男子的传播 治疗（ART）。青少年妇女协会本身的干预措施包括生物医学干预措施，如抗逆转录病毒疗法， 基于杀微生物剂或接触前预防措施，以及包括安全空间在内的社会保障干预措施， 现金转移支付，用于继续上学、生活技能培训和社区支持改变性别规范。 因为没有一个单一的生物医学，行为或结构干预是非常有效的AGYW， 有效的方法可能涉及多种干预措施的结合。组合的成功 预防干预措施不仅取决于其组成部分的有效性， 广泛执行和个别组成部分的可接受性，这反过来又影响到 坚持。项目实施者面临的一个挑战是从临床试验过渡到项目实施 由于试验人群与AGYW的总体人群不同-因此来自试验参与者的数据 可能无法预测现实世界的可接受性以及个人、提供者和社区属性对 * 青年女青年协会接受并坚持艾滋病毒预防战略。另一个挑战是程序化数据 通常不是假设驱动的，并且在研究设计、数据和方法上不保持相同的研究严谨性。 随机临床试验所做的收集和注释。因此，仅依靠程序数据进行多级 因素分析很可能产生有偏见的结果。在这个应用程序中，我们解决了以下挑战： 分析多种因素对AGYW的吸收和坚持的影响，利用来自 梦想倡议计划和撒哈拉以南非洲AGYW的临床试验。我们的具体目标是： 目标1.确定与PrEP摄取相关的多水平个人和社区风险因素， AGYW之间的依从性结果，使用DREAMS倡议的计划数据。 目标2.加强对影响AGYW吸收和遵守的因素的多层次分析 目标1，利用来自DREAMS Initiative和HPTN随机临床试验的数据。 目标3。预测多层次因素对AGYW摄入和艾滋病预防依从性的影响 并评估其对人口的影响。 目标4。在随机临床试验和实施研究之间建立桥梁，以评估联合用药 更精确的预防干预一揽子计划，以促进青年妇女协会的吸收和遵守。