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)是一种战略，如果坚持下去，就有可能提供对艾滋病毒的高度保护 是高的。关于向非洲年轻妇女提供PrEP的两个关键问题需要评估：1)如何确定 并激励处于风险中的您使用PrEP，以及2)如何有效地支持他们遵守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商驱动的方法 风险评分，以及以患者为导向的方法，鼓励患者评估他们接受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接受率 并遵守PrEP，而不是仅由提供商驱动的方法。对于PrEP遵从性，尚不清楚 非洲青年会需要遵守支持的类型；一些妇女可能高度遵守标准 短暂咨询或双向短信，在这种情况下，只需使用更密集的 为不遵守规定的妇女提供坚持支持。我们将使用随机化的顺序多重分配 试验(SMART)设计，评估从简短咨询开始的阶梯式PrEP遵守支持模式，或者 双向短信，两者都很容易扩展，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 在使用PrEP 3个月后粘连。我们假设，如果您有动力使用PrEP，他们会坚持使用 通过简短的咨询，提醒和分类，提供简单的支持。那些需要额外坚持的人 支持将对药物水平反馈和每月咨询做出回应，以解决依从性挑战。我们的 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定- 除了提供商管理的风险评分之外，支持工具还会对PrEP启动产生积极影响 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您的风险 感知和PrEP启动；目标1b：确定决策工具是否改变了您的决策 提供者对PrEP的咨询。目标2.使用智能设计测试可伸缩的阶梯式模型 发起PrEP的南非年轻女性中的坚持支持策略。我们将随机选择330人 约翰内斯堡16-25岁的女性，开始PrEP到标准护理，简短的咨询，有或没有两个- 用短信的方式。将在第三个月使用替诺福韦水平对女性的依从性进行评估，将女性归类为“应答者” 和“无回应者”。无响应者将接受二次随机分组，每季度就他们的 药物水平或每月CBT咨询。主要结果将在12个月后检测到药物的PrEP。 在此项目中，我们将确定促进PrEP采用和可扩展遵从性支持的最佳策略 对于南非青年党来说，这是全球新增艾滋病毒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.