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HIV预防试验中，南非年轻妇女（YW）的年HIV发病率为5-10％。 暴露前预防（PREP）是一种策略，具有对HIV提供高保护的潜力 高。需要评估有关向非洲年轻女性提供准备的两个关键问题：1）如何识别 并激励高危YW使用PREP，以及2）如何有效地支持其准备依从性。为了进行准备， 我们将根据声音根据行为和临床风险评估评估提供者驱动的方法 风险评分以及一种以患者为导向的方法来鼓励患者评估他们的风险和准备动机 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 与仅提供提供商驱动的方法相比，对准备的依从性。为了依从性，尚不清楚什么级别 非洲YW需要依从性支持的类型；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 对不遵守的妇女的依从性支持。我们将使用随机分配的顺序多个分配 试用（智能）设计，以评估从简短咨询或 双向SMS，两者都很容易扩展，然后评估两种策略的有效性 仅在不在 预备使用3个月后，粘附。我们假设，如果YW有动力使用准备，他们将遵守 通过简短的咨询提供简单的支持，提醒分类。那些需要额外遵守的人 支持将响应药物水平的反馈和每月咨询，以应对依从性挑战。我们的 具体目的是：目标1。使用随机设计，测试是否使用面向患者的决策 - 支持工具除了提供者管理的风险评分积极影响准备启动 与仅使用风险评分相比。目标1A：评估决策工具的使用是否影响YW的风险 感知和准备计划；目标1B：确定决策工具是否改变了YW的决策和 提供者关于准备的咨询。 AIM 2。测试，使用智能设计，逐步的可扩展模型 持续支持启动预备的南非年轻妇女的依从性策略。我们将随机化330 约翰内斯堡16-25岁的妇女在有或没有两次的情况下为标准的护理简短咨询做准备 方式短信。依从性将在第3个月使用Tenofovir水平进行评估，以将女性归类为“响应者” 和“非反应者”。非反应者将进行次要随机化以进行季度咨询 药物水平或每月CBT咨询。主要结果将在12个月时检测到药物。 在这个项目中，我们将确定促进预备吸收和可扩展依从性支持的最佳策略 对于南非YW，全球新的艾滋病毒感染数量最多。

项目成果

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.

• DOI: 10.1002/jia2.26154
• 发表时间: 2023-08
• 期刊: Journal of the International AIDS Society
• 影响因子: 6

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

• DOI: 10.1371/journal.pone.0266665
• 发表时间: 2022
• 期刊: PLOS ONE
• 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-Moretlwe, Sinead
• 通讯作者: Delany-Moretlwe, Sinead