PrEP for Young South African Women: Evaluating Uptake by Risk Screening or a Decision Support Tool and Scaled Adherence Support Using a SMART Design

摘要 在最近的艾滋病毒预防试验中，南非年轻妇女（YW）的艾滋病毒年发病率为5 - 10%。 暴露前预防（PrEP）是一种策略，如果坚持， 很高需要评估关于向非洲年轻妇女提供PrEP的两个关键问题：1）如何确定 并激励有风险的YW使用PrEP，以及2）如何有效地支持他们坚持PrEP。对于PrEP摄取， 我们将通过VOICE评估基于行为和临床风险评估的提供者驱动的方法 风险评分，以及以患者为导向的方法，以鼓励患者评估其PrEP的风险和动机 使用决策支持工具。我们假设，以患者为中心的决策工具将导致更高的吸收， 和坚持PrEP比单独提供者驱动的方法。对于PrEP依从性，尚不清楚什么水平 非洲青年工作者需要遵守支持的类型;一些妇女可能高度遵守标准 简短的咨询或双向短信，在这种情况下，只使用更密集的服务可以节省资源。 为不遵守的妇女提供遵守支持。我们将使用顺序多重分配随机 试验（SMART）设计，以评估从简短咨询开始的分步PrEP依从性支持模型，或 双向短信，这两个都是很容易扩展，然后评估两种策略的有效性， 强化依从性支持（药物水平反馈和认知行为咨询）仅适用于那些没有 使用PrEP 3个月后粘附。我们假设，如果YW有动机使用PrEP，他们会坚持 通过简短的咨询，提醒和分类来提供简单的支持。那些需要额外坚持的人 支持将响应药物水平反馈和每月咨询，以解决依从性挑战。我们 具体目标是：目标1。使用随机设计，测试是否使用面向患者的决策- 除了提供者管理的风险评分外，支持工具对PrEP启动有积极影响 与单独使用风险评分相比。目标1a：评估决策工具的使用是否影响YW的风险 感知和PrEP启动;目标1b：确定决策工具是否改变YW的决策， 提供者关于PrEP的咨询。目标2。测试，使用SMART设计，可扩展的阶梯模型 在南非年轻女性谁启动PrEP坚持支持策略。我们将随机330 约翰内斯堡16 - 25岁的妇女，她们开始接受PrEP标准护理的简短咨询， SMS的方式。坚持将在第3个月使用替诺福韦水平进行评估，将女性归类为“反应者” “无反应者”。无应答者将接受二次随机分组至季度咨询， 药物水平或每月CBT咨询。主要结局将是在12个月时检测到药物的PrEP。 在本项目中，我们将确定促进PrEP吸收和可扩展依从性支持的最佳策略 南非YW是全球艾滋病毒新感染人数最多的国家。

Abstract South African young women (YW) have annual HIV incidence rates of 5-10% in recent HIV prevention trials. Pre-exposure prophylaxis (PrEP) is a strategy with potential to provide high protection against HIV if adherence is high. Two key questions about PrEP delivery to African young women need to be assessed: 1) how to identify and motivate at-risk YW to use PrEP, and 2) how to efficiently support their PrEP adherence. For PrEP uptake, we will evaluate a provider-driven approach based on behavioral and clinical risk assessment through the VOICE risk score, and a patient-directed approach to encourage patients to assess their risks and motivations for PrEP using a decision support tool. We hypothesize that a patient-centered decision tool will result in higher uptake of and adherence to PrEP than a provider-driven approach alone. For PrEP adherence, it is unknown what level and type of adherence support is needed for African YW; some women may be highly adherent with standard brief counseling or two-way SMS, in which case resources would be saved by only using more intensive adherence support for women who are not adherent. We will use a sequential multiple assignment randomized trial (SMART) design to evaluate a stepped PrEP adherence support model that begins with brief counseling, or two-way SMS, both of which are readily scalable, and then assesses the effectiveness of two strategies for more intensive adherence support (drug level feedback and cognitive behavioral counseling) only in those not adherent after 3 months of PrEP use. We hypothesize that if YW are motivated to use PrEP, they will adhere well with simple support through brief counseling, reminders with triage. Those who need additional adherence support will respond to drug level feedback and monthly counseling to address adherence challenges. Our Specific Aims are: Aim 1. Using a randomized design, test whether use of a patient-facing decision- support tool in addition to a provider-administered risk score positively influences PrEP initiation compared to use of a risk score alone. Aim 1a: Evaluate if use of the decision tool affects YW’s risk perception and PrEP initiation; Aim 1b: Determine if the decision tool alters YW’s decision-making and providers’ counseling about PrEP. Aim 2. Test, using a SMART design, a stepped model of scalable adherence support strategies in South African young women who initiate PrEP. We will randomize 330 women ages 16-25 in Johannesburg who initiate PrEP to standard of care brief counseling with or without two- way SMS. Adherence will be assessed at month 3 using tenofovir levels to categorize women as ‘responders’ and ‘non-responders.’ Non-responders will undergo secondary randomization to quarterly counseling about their drug levels or monthly CBT counseling. The primary outcome will be on PrEP with drug detected at 12 months. In this project, we will determine optimal strategies for facilitating PrEP uptake and scalable adherence support for South African YW, accounting for the greatest number of new HIV infections globally.