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

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很高。保护 世界卫生组织建议， 向艾滋病毒阴性孕妇和产后妇女提供口服替诺福韦（TFV）暴露前预防（PrEP） 高负担环境中的妇女。尽管大多数有艾滋病毒风险因素的肯尼亚孕妇在接受PrEP时， 在提供的情况下，>50%的人在开始后30天内停止PrEP，并且次优依从性很常见。至今没有 改善PrEP依从性的干预研究包括孕妇或产后妇女。我们改编了一条短信 通信平台（mWACh）发送PrEP定制的，基于理论的SMS，以促进遵守之间 在一项非随机试验中，我们发现mWACh-PrEP接受者更多 可能坚持使用PrEP并自我报告高依从性。我们建议进行一项随机试验， mWACh-PrEP工具对妊娠期间至产后期间PrEP依从性的影响。我们 还将利用普罗克特实施成果框架收集成本和交付数据， 转化为日常实践。我们的总体假设是，mWACh-PrEP将提高PrEP依从性 在有感染艾滋病毒风险的母亲中，这种做法应能为患者和提供者所接受，并具有成本效益。通过利用我们 团队在肯尼亚西部的研究基础设施，我们处于独特的地位，以执行以下AIMS： 目的1-确定mWACh-PrEP工具对妊娠期间PrEP依从性的影响， 在ANC-PrEP中开始PrEP的女性中，我们将进行一项2组随机试验 在未感染HIV的患者中比较mWACh-PrEP与标准治疗（SOC，即门诊依从性咨询） 启动PrEP的艾滋病毒感染风险高的孕妇（由经验证的风险评分定义）。 结果将是产后6个月时的依从性（TFV毛发水平>0.038 ng/mg;与每周7片一致）。 次要结局将包括STI发病率、依从性辅助因素和预防有效依从性（时间- 与风险行为的不同一致性）。探索性结果将包括艾滋病毒发病率和 假设：与SOC相比，mWACh-PrEP将增加PrEP依从性。 目标2-评估常规ANC中实施mWACh-PrEP的障碍和促进因素。使用普罗克特 框架，我们通过与ANC-PrEP进行访谈和焦点小组来评估可接受性和可行性 使用者、提供者和健康规划者。假设：将确定mWACh-PrEP准备就绪的指示。 目标3-估计在ANC-PrEP内实施mWACh-PrEP的成本效益，每例艾滋病毒感染， 避免了残疾调整生命年（DALY）。我们使用目标1中的数据，进行微观成本计算和时间- 从付款人的角度估计mWACh-PrEP的成本的动议研究。增量成本- 将计算与SOC相比，每例HIV感染和避免的DALY的有效性比（ICER）。假设： 通过改善mWACh-PrEP的ICER来验证PrEP和ANC结果的数据。

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.