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

基本信息

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
项目类别：
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

项目摘要

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.

在艾滋病毒高流行地区，妇女在怀孕和哺乳期间感染艾滋病毒的风险较高。世界卫生组织建议，消除艾滋病毒母婴传播为 HIV 阴性孕妇和产后提供基于口服替诺福韦 (TFV) 的暴露前预防 (PrEP) 尽管大多数有艾滋病毒危险因素的肯尼亚孕妇在接受 PrEP 时仍会接受。超过 50% 的人在开始后 30 天内停止 PrEP，并且依从性不佳的情况很常见。我们对怀孕或产后妇女进行了提高 PrEP 依从性的干预研究。通信平台 (mWACh) 发送根据 PrEP 定制的、基于理论的短信，以促进患者的遵守在一项非随机试验中，我们发现 mWACh-PrEP 接受者更多。可能会坚持使用 PrEP 并自我报告高依从性，我们建议进行一项随机试验来确定。 mWACh-PrEP 工具对孕期至产后期 PrEP 依从性的影响。还将使用 Proctor 实施成果框架收集有关成本和交付的数据，以加快我们的总体假设是 mWACh-PrEP 将提高 PrEP 的依从性。在有感染艾滋病毒风险的母亲中，患者和提供者可以接受，并且具有成本效益。团队在肯尼亚西部的研究基础设施，我们具有独特的优势来执行以下目标：目标 1- 通过以下方法确定 mWACh-PrEP 工具对妊娠期间 PrEP 依从性的影响在 ANC-PrEP 内启动 PrEP 的女性的产后期我们将进行一项 2 组随机试验。在未感染 HIV 的人群中比较 mWACh-PrEP 与标准护理（SOC，即诊所依从性咨询）启动 PrEP 的具有高 HIV 感染风险（由经过验证的风险评分定义）的孕妇。结果是产后 6 个月坚持服用（TFV 毛发水平 >0.038 ng/mg；与每周 7 粒药一致）。次要结果将包括 STI 发病率、依从性辅助因素和预防有效依从性（时间- 探索性结果将包括艾滋病毒发病率和假设：与 SOC 相比，mWACh-PrEP 会提高 PrEP 依从性。目标 2 – 使用 Proctor 评估常规 ANC 中 mWACh-PrEP 实施的障碍和促进因素。框架中，我们通过 ANC-PrEP 进行访谈和焦点小组来评估可接受性和可行性用户、提供者和健康规划者：将确定 mWACh-PrEP 的准备情况。目标 3 – 评估在 ANC-PrEP 中实施 mWACh-PrEP 的成本效益，针对每个 HIV 感染者和我们使用目标 1 中的数据并进行微观成本计算和时间和- 从付款人的角度估计 mWACh-PrEP 成本的运动研究增量成本。将计算每次 HIV 感染的有效性比率 (ICER) 以及与 SOC 相比避免的 DALY：将 PrEP 和 ANC 结果数据与改进 mWACh-PrEP 的 ICER 相结合。