PrEP among high-risk young women in South Africa: real-world barriers to use and patterns of re-initiation and PrEP cycling

项目摘要 重要性：艾滋病毒感染率在少女和年轻妇女中不成比例地高（AGYW）， 年轻女性性工作者（YFSW）PrEP已被证明是一种有效的女性- 控制，生物医学的机会，以防止新的艾滋病毒感染。尽管PrEP的既定功效， 预防艾滋病毒，在临床试验和现实世界环境中， 扶贫南非在全国范围内扩大PrEP的规模也受到了其他地方出现的同样问题的挑战， 包括年轻妇女的入职率和保留率同样很低。为了增加PrEP的挑战， 与治疗需求不同，PrEP需求不仅因个体而异，而且随时间而变化 在个体内部，取决于风险的变化。为了实现本提案的目标，我们将建立一个 与南非最大的年轻女性PrEP提供商TB HIV Care（THC）建立了牢固的现有合作伙伴关系。 具体目标：我们的目标是1）描述个体和结构特征的时间趋势 在参加THC计划的符合PrEP资格的YFSW和AGYW中，与PrEP启动相关 在2016 - 2020年之间，2）评估与PrEP保留相关的特征，并检查总体变化 随着时间的推移，在2016 - 2020年期间在THC计划中发起PrEP的YFSW和AGYW中，以及3）探索 在THC项目中启动PrEP的YFSW和AGYW之间的重新启动和PrEP循环模式 2016 - 2020年之间。本研究产生的推论将直接反馈并告知THC计划。 方法：对于所有三个目标，我们将利用常规收集的24 000多名高风险年轻妇女的数据 由THC提供，包括个人服务用户临床文件和程序日志。对于目标1，我们将定量地 使用离散事件时间分析比较启动PrEP的患者和未启动PrEP的患者的特征 考虑竞争风险，并模拟PrEP启动的纵向模式。对于目标2，我们将研究 作为该计划的一部分发起的妇女中保留PrEP，并定量比较特征 对于那些谁是和不保留在PrEP。我们还将模拟模式的PrEP保留在日历上 时间对于目标3，我们将使用限制性平均生存时间分析来表征重新启动的模式， PrEP循环（女性停止和重新开始），包括最初 发起的人是a。保留在PrEP上，B.参与该计划，但不再使用PrEP（低风险和高风险）， C.输给了节目组，D。随着时间的推移感染艾滋病毒。 奖学金信息：拟议的PI Rao将利用培训计划，包括选定的课程， 量身定制的指导和专业发展，以进一步她的知识，技能和经验， 完成拟议的研究，并成为一个成功的学术流行病学家，研究实施 科学和常规数据的使用，以改善艾滋病毒服务，特别是对边缘化妇女的服务。

PROJECT SUMMARY Significance: HIV incidence is disproportionately high among adolescent girls and young women (AGYW) and young female sex workers (YFSW) in South Africa. PrEP has been shown to be an efficacious, female- controlled, biomedical opportunity to prevent new HIV infections. Despite the established efficacy of PrEP to prevent HIV, initiation of and retention on PrEP by women in both clinical trial and real-world settings has been poor. National scale-up of PrEP in South Africa has been challenged by the same issues seen elsewhere, including similarly low levels of initiation and retention among young women. To add to this challenge of PrEP retention, PrEP need, unlike treatment need, not only differs among individuals, but also can vary over time within individuals, depending on changing risk. To accomplish the goals of this proposal, we will build on a strong existing partnership with TB HIV Care(THC), the largest PrEP provider to young women in South Africa. Specific Aims: We aim to 1) characterize temporal trends of and individual and structural characteristics associated with PrEP initiation, among PrEP eligible YFSW and AGYW who participated in the THC program between 2016-2020, 2) assess characteristics associated with PrEP retention and examine aggregate changes over time, among YFSW and AGYW who initiated PrEP at the THC program between 2016-2020, and 3) explore patterns of re-initiation and PrEP cycling among YFSW and AGYW who initiated PrEP at the THC program between 2016-2020. Inference generated by this study will directly feed back and inform the THC program. Approach: For all three aims, we will utilize routinely collected data on over 24,000 high-risk young women served by THC, including individual service user clinical files and program logs. For Aim 1, we will quantitatively compare characteristics for those who initiated PrEP and those who did not using discrete time-to-event analysis accounting for competing risks, and model the longitudinal patterns of PrEP initiation. For Aim 2, we will examine retention on PrEP among women who initiated as part of the program, and quantitatively compare characteristics for those who are and are not retained on PrEP. We will also model patterns of PrEP retention over calendar time. For Aim 3, we will use a restricted mean survival time analysis to characterize patterns of re-initiation and PrEP cycling (women discontinuing and re-initiating), including the proportion of women who had originally initiated who are a. retained on PrEP, b. engaged in the program, but no longer on PrEP (both low and high risk), c. lost to the program, and d. HIV-infected over time. Fellowship Information: Proposed PI Rao will leverage the training program, including selected courses, tailored mentorship, and professional development, to further her knowledge, skills, and experience to complete the proposed research and become a successful academic epidemiologist, studying implementation science and the use of routine data to improve HIV services particularly for marginalized women.