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。去保护 世界卫生组织建议，妇女和实现消除母婴艾滋病毒传播 为HIV阴性孕妇和产后提供基于替诺福韦(TFV)的暴露前预防(PrEP) 处于高负担环境中的女性。尽管大多数有艾滋病毒风险因素的肯尼亚孕妇在以下情况下接受PrEP 提供的，50%的PrEP在启动后30天内停止使用，遵守情况不佳的情况很常见。到目前为止，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、基于理论的短信，以促进 启动PrEP的孕妇。在一项非随机试验中，我们发现mWACh-PrEP接受者比 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PrEP依从性的影响我们 还将使用Proctor实施成果框架收集关于成本和交付的数据，以加快 将其转化为常规做法。我们的首要假设是mWACh-PrEP将提高PrEP的依从性 在有艾滋病毒风险的母亲中，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，我们处于独特的地位，可以实现以下目标： 目的1-确定mWACh-PrEP工具对孕期PrEP依从性的影响 在ANC-PrEP中启动PrEP的妇女的产后期。我们将进行一项双臂随机试验 未感染HIV者的mWACh-PrEP与标准护理(SOC，即门诊依从性咨询)的比较 启动PrEP的具有高HIV感染风险(由有效风险评分定义)的孕妇。初级阶段 结果将是在产后6个月坚持使用(TFV头发水平&GT；0.038毫克/毫克；每周7片)。 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- 遵守与危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 手臂对围产儿的影响。假设：与SOC相比，mWACh-PrEP将增加PrEP的依从性。 目标2-评估在常规ANC内实施mWACh-PrEP的障碍和促进者。使用Proctor 框架，我们通过与非国大--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。假设：mWACh-PrEP准备就绪的迹象将被确定。 目标3-评估在ANC-PrEP内实施mWACh-PrEP的成本效益，按艾滋病毒感染和 避免了残疾调整生命年(DALY)。我们使用来自AIMS 1的数据，并进行微观成本计算和时间和- 动议研究，从支付者的角度估计mWACh-PrEP的成本。增量成本- 将计算每个HIV感染的有效率(ICER)和与SOC相比避免的DALY。假设： 将PrEP和ANC结果的数据与mWACh-PrEP的改进ICER结合起来。

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.