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: 10175041
• 负责人: CONNIE L CELUM
• 金额: $ 58.42万
• 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 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10175041
• 关键词: AIDS prevention; Accounting; Address; Adherence; Affect; African; Age; Alcohol consumption; Anti-Retroviral Agents; Behavioral; Cellular Phone; Characteristics; Clinic; Cognitive; Conflict (Psychology); Contraceptive Agents; Counseling; Country; Couples; Decision Making; Feedback; HIV; HIV Infections; HIV Seronegativity; 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; Sequential Multiple Assignment Randomized Trial; Sexually Transmitted Diseases; South Africa; South African; Tenofovir; Testing; Triage; Visit; Woman; Youth; base; birth control; clinical risk; design; digital; effectiveness evaluation; experience; female sex worker; improved; men who have sex with men; patient oriented; placebo controlled study; pre-exposure prophylaxis; primary outcome; responders and non-responders; risk perception; screening; side effect; 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 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使用 PrEP， 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渴望以患者为中心的决策工具能够提高使用率。 对于 PrEP 的坚持程度，目前尚不清楚。 非洲 YW 需要某种类型的遵守支持；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，仅使用更密集的方式即可节省资源 对不依从的女性的依从性支持我们将使用随机的连续多重分配。 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 个月后坚持使用 我们承诺，如果 YW 有动力使用 PrEP，他们就会坚持使用。 通过简短的咨询、分类提醒等简单的支持，就可以很好地帮助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，以解决我们的依从性挑战。 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 YW 的决策和 目标 2. 使用 SMART 设计（可扩展的阶梯模型）进行测试。 我们将对 330 名启动 PrEP 的南非年轻女性进行随机分组。 约翰内斯堡 16-25 岁的女性开始 PrEP 进行标准护理简短咨询，有或没有两次 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 咨询的主要结果将是在 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。

项目成果

Adaptive HIV pre-exposure prophylaxis adherence interventions for young South African women: Study protocol for a sequential multiple assignment randomized trial.

南非年轻女性的适应性艾滋病毒暴露前预防依从性干预措施：序贯多重分配随机试验的研究方案。

• 发表时间: 2022
• 影响因子: 3.7
• 作者: Velloza, Jennifer;Poovan, Nicole;Ndlovu, Nontokozo;Khoza, Nomhle;Morton, Jennifer F;Omony, Jeanne;Mkwanazi, Edwin;Grabow, Cole;Donnell, Deborah;Munthali, Richard;Baeten, Jared M;Hosek, Sybil;Celum, Connie;Delany
• 通讯作者: Delany

A decision support tool has similar high PrEP uptake and increases early PrEP persistence in adolescent girls and young women in South Africa: results from a randomized controlled trial.

决策支持工具具有类似的高 PrEP 吸收率，并提高了南非少女和年轻女性的早期 PrEP 持久性：随机对照试验的结果。

• 发表时间: 2023-08
• 影响因子: 6
• 作者: Celum, Connie;Seidman, Dominika;Travill, Danielle;Dehlendorf, Christine;Gumede, Sanele;Zewdie, Kidist;Wilson, Whitney;Morton, Jennifer F;Baeten, Jared M;Donnell, Deborah;Delany
• 通讯作者: Delany