mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence during Pregnancy and Breastfeeding

mWACh-PrEP：基于短信的支持干预措施，以增强怀孕和母乳喂养期间 PrEP 的依从性

• 批准号: 10656582
• 负责人: John Kinuthia
• 金额: $ 57.4万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-18 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10656582
• 关键词: Acute; Address; Adherence; African; Behavioral; Birth; Blood; Breast Feeding; Characteristics; Childbirth; Clinic; Collaborations; Communication; Communication Tools; Counseling; Country; Data; Diphosphates; Dose; Dryness; Event; Face; Focus Groups; Future; Growth; HIV; HIV Infections; HIV Seronegativity; HIV risk; Hair; Health; Health system; High Risk Woman; Incidence; Individual; Intervention; Intervention Studies; Interview; Kenya; Life; Maternal Health; Maternal and Child Health; Mental Depression; Modeling; Mother-to-child HIV transmission; Mothers; Motivation; Nurses; Oral; Outcome; Patient Self-Report; Patients; Perinatal; Pharmaceutical Preparations; Population; Positioning Attribute; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Prevalence; Prevention; Prevention Research; Proctor framework; Provider; Qualitative Evaluations; Randomized; Readiness; Recommendation; Reporting; Research Infrastructure; Risk; Risk Behaviors; Risk Factors; Spottings; Symptoms; Tenofovir; Time; Time and Motion Studies; Translations; Use Effectiveness; Visit; Woman; World Health Organization; acceptability and feasibility; antenatal care; antiretroviral therapy; arm; care delivery; care outcomes; cofactor; cost; cost effective; cost effectiveness; cost estimate; cost-effectiveness ratio; critical period; disability-adjusted life years; follow-up; implementation outcomes; improved; incremental cost-effectiveness; member; microcosting; motherhood; neonatal death; perinatal outcomes; pill; pre-exposure prophylaxis; pregnant; prevent; primary outcome; randomized trial; routine practice; scale up; secondary outcome; side effect; skills; standard of care; theories; therapy adherence; tool; trial comparing; two way texting

In high HIV prevalence regions, women are at high risk for HIV during pregnancy and breastfeeding. To protect women and reach elimination of mother-to-child HIV transmission, the World Health Organization recommends offering oral tenofovir (TFV)-based pre-exposure prophylaxis (PrEP) to HIV-negative pregnant and postpartum women in high-burden settings. Although most pregnant Kenyan women with HIV risk factors accept PrEP when offered, >50% discontinue PrEP within 30 days of initiation and sub-optimal adherence is common. To date, no intervention studies to improve PrEP adherence include pregnant or postpartum women. We adapted an SMS communication platform (mWACh) to send PrEP-tailored, theory-based SMS to facilitate adherence among pregnant women who initiate PrEP. In a non-randomized pilot, we found that mWACh-PrEP recipients were more likely to persist with PrEP use and to self-report high adherence. We propose a randomized trial to determine the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy through the postpartum period. We will also gather data on cost and delivery using the Proctor Implementation Outcomes Framework to expedite translation into routine practice. Our overarching hypothesis is that mWACh-PrEP will improve PrEP adherence among mothers at-risk for HIV, be acceptable to patients and providers, and be cost-effective. By leveraging our team’s research infrastructure in Western Kenya, we are uniquely positioned to execute the following AIMS: Aim 1- To determine the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy through the postpartum period among women who initiate PrEP within ANC-PrEP. We will conduct a 2-arm randomized trial comparing mWACh-PrEP vs standard of care (SOC, i.e. in-clinic adherence counseling) among HIV-uninfected pregnant women with high HIV acquisition risk (defined by validated risk score) who initiate PrEP. The primary outcome will be adherence at 6 months postpartum (TFV hair levels >0.038 ng/mg; consistent with 7 pills/ week). Secondary outcomes will include STI incidence, adherence cofactors, and prevention-effective adherence (time- varying alignment of adherence with risk behaviors). Exploratory outcomes will include HIV incidence and perinatal outcomes by arm. Hypothesis: mWACh-PrEP will increase PrEP adherence compared to SOC. Aim 2– Evaluate barriers and facilitators of mWACh-PrEP implementation within routine ANC. Using the Proctor framework, we assess acceptability and feasibility by conducting interviews and focus-groups with ANC-PrEP users, providers, and health planners. Hypothesis: Indications for readiness of mWACh-PrEP will be identified. Aim 3– Estimate the cost-effectiveness of implementing mWACh-PrEP within ANC-PrEP, per HIV infection and disability-adjusted life-year (DALY) averted. We use data from Aims 1 and conduct micro-costing and time-and- motion studies to estimate the cost of mWACh-PrEP from a payer perspective. The incremental cost- effectiveness ratio (ICER) per HIV infection and DALY averted compared to SOC will be calculated. Hypothesis: Incorporating data on PrEP and ANC outcomes with improve ICERs for mWACh-PrEP.

在高艾滋病毒患病率地区，妇女在怀孕和母乳喂养期间患HIV的高风险。保护 妇女并消除母子艾滋病毒的传播，世界卫生组织建议 提供口服替诺福韦（TFV）的预防前预防（PREP） 妇女处于高负荷环境中。尽管大多数怀孕的肯尼亚妇女患有艾滋病毒危险因素 提供的是，在启动后30天内停止使用> 50％的准备，而次优的依从性很常见。迄今为止，没有 改善预科依从性的干预研究包括孕妇或产后妇女。我们调整了短信 通信平台（MWACH）发送预算基于理论的SMS，以促进依从性 发起准备的孕妇。在非随机飞行员中，我们发现MWACH-PREP接收者更多 可能会持续使用准备和自我报告高依从性。我们提出了一项随机试验以确定 MWACH-PREP工具对产后期间怀孕期间的依从性的影响。我们 还将使用Proctor实施成果框架收集有关成本和交付的数据，以加快 转化为常规实践。我们的总体假设是MWACH-PREP将提高准备依从性 在母亲在艾滋病毒中处于危险中，患者和提供者可以接受，并具有成本效益。通过利用我们的 团队在肯尼亚西部的研究基础设施，我们处于执行以下目标的独特位置： 目标1-确定MWACH-PREP工具对通过该怀孕期间的准备依从性的影响 在ANC-PREP内发起准备的妇女的产后时期。我们将进行2臂随机试验 在HIV未感染的 启动PREP的艾滋病毒收购风险高的孕妇（由经过验证的风险评分定义）。主要 结果将是产后6个月的依从性（TFV头发水平> 0.038 ng/mg；与7粒/周一致）。 次要结果将包括STI事件，依从性辅助因子和预防有效的依从性（时间 - 依从性与风险行为的一致性不同）。探索结果将包括HIV事件和 围产期结局。假设：与SOC相比，MWACH-PREP将提高预依从性。 目标2 - 评估常规ANC内MWACH-PREP实施的障碍和促进者。使用Proctor 框架，我们通过与ANC-PREP进行访谈和重点组来评估可接受性和可行性 用户，提供者和健康计划者。假设：将确定MWACH-PREP准备的适应症。 目标3 - 估计在ANC-PREP内实施MWACH-PREP的成本效益，每个艾滋病毒感染和 避免了残疾调整的生活年度（DALY）。我们使用AIM 1的数据并进行微构成和时间和时间 从付款人的角度来看，运动研究以估算MWACH-PREP的成本。增量成本 - 将计算每只HIV感染的有效性比（ICER）与SOC相比避免的Daly。假设： 将有关PREP和ANC结果的数据与MWACH-PREP改进的ICER相结合。