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

南非年轻女性的 PrEP：通过风险筛查或决策支持工具以及使用 SMART 设计的大规模依从性支持来评估其接受情况

• 批准号: 9404078
• 负责人: CONNIE L CELUM
• 金额: $ 70.04万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-22 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9404078
• 关键词: AIDS prevention; Accounting; Address; Adherence; Adverse effects; Affect; African; Age; Alcohol consumption; Anti-Retroviral Agents; Behavioral; Cellular Phone; Characteristics; Clinic; Cognitive; Conflict (Psychology); Contraceptive Agents; Counseling; Country; Couples; Decision Making; Effectiveness; Feedback; HIV; HIV Infections; HIV prevention trial; Health; Heterosexuals; Incidence; Infection; Interview; Medicine; Modeling; Motivation; Patients; Pharmaceutical Preparations; Placebos; Population; Process; Provider; Psychological reinforcement; Qualitative Methods; Randomized; Reaction; Resources; Risk; Risk Assessment; Safety; Sexually Transmitted Diseases; South Africa; South African; Tenofovir; Testing; Triage; Visit; Woman; Youth; base; birth control; clinical risk; design; digital; experience; female sex worker; improved; men who have sex with men; patient oriented; placebo controlled study; pre-exposure prophylaxis; primary outcome; randomized trial; responders and non-responders; risk perception; screening; social stigma; standard of care; support tools; tool; trial design; uptake; young woman

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.

抽象的 在最近的艾滋病毒预防试验中，南非年轻女性 (YW) 的艾滋病毒年发病率为 5-10%。 暴露前预防 (PrEP) 是一种有潜力提供针对 HIV 的高度保护的策略，如果坚持的话 是高的。需要评估向非洲年轻女性提供 PrEP 的两个关键问题：1) 如何识别 并激励有风险的 YW 使用 PrEP，以及 2) 如何有效支持他们坚持 PrEP。对于 PrEP 的摄取， 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方法 风险评分，以及以患者为导向的方法，鼓励患者评估其风险和 PrEP 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采用率 并坚持 PrEP，而不是仅采用提供者驱动的方法。对于 PrEP 依从性，尚不清楚什么水平 非洲 YW 需要何种类型的依从性支持；有些女性可能高度遵守标准 简短的咨询或双向短信，在这种情况下，仅使用更密集的方式即可节省资源 对不依从的女性提供依从支持。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阶梯式 PrEP 依从性支持模型，或 双向短信，两者都易于扩展，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）仅适用于那些不这样做的人 使用 PrEP 3 个月后坚持。我们假设，如果 YW 有动机使用 PrEP，他们就会坚持 通过简短的咨询、分类提醒等简单的支持，效果很好。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策- 除了提供者管理的风险评分之外，支持工具也会对 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会影响 YW 的风险 感知和 PrEP 启动；目标 1b：确定决策工具是否改变了 YW 的决策并 提供者有关 PrEP 的咨询。目标 2. 使用 SMART 设计测试可扩展的阶梯模型 南非年轻女性发起 PrEP 的坚持支持策略。我们将随机抽取 330 约翰内斯堡 16-25 岁的女性开始 PrEP 并接受标准护理简短咨询，有或没有两次： 方式短信。将在第 3 个月使用替诺福韦水平评估依从性，将女性归类为“反应者” 和“无反应者”。无反应者将接受二次随机分组，每季度接受一次关于他们的情况的咨询。 药物水平或每月 CBT 咨询。主要结果将是在 12 个月时检测到药物的 PrEP。 在这个项目中，我们将确定促进 PrEP 的采用和可扩展的依从性支持的最佳策略 南非 YW 是全球新增艾滋病毒感染人数最多的人。