Project 2 - Improving HIV prevention among postpartum women in Lilongwe, Malawi: the postpartum prevention package [Parent Title: PREVENTING INFANT INFECTIONS WITH IMPLEMENTATION SCIENCE IN MALAWI]

项目概要 在消除母婴传播的宏伟目标方面取得了令人瞩目的进展 (EMCT) 全球范围内。在高效的 EMTCT 项目中，抗逆转录病毒疗法的采用率很高，新来的比例不断增加 婴儿感染源于产妇感染；在撒哈拉以南非洲地区，近三分之一的婴儿 传播与怀孕或母乳喂养期间获得的艾滋病毒感染有关。驱动力 生理变化和行为变化，包括恢复无套性交、产后 这段时期是感染艾滋病病毒的高危时期。在马拉维，三分之一的新感染艾滋病毒儿童 感染归因于母乳喂养期间感染艾滋病毒的妇女。改善产后艾滋病毒 需要预防来预防儿科感染。一个有希望的艾滋病毒预防机会是艾滋病毒预防 暴露预防（PrEP）。按处方服用，每日口服 PrEP 可有效预防 HIV，并且在治疗期间是安全的 母乳喂养。不幸的是，亚健康地区的产后妇女对 PrEP 的采用和充分坚持 包括马拉维在内的撒哈拉非洲地区一直很贫穷。新型长效 PrEP 制剂，包括注射剂 PrEP 是 HIV 预防的一项有前途且可能转变范式的进步，提供了更离散和更 给药方便。然而，为了最大限度地发挥 PrEP（口服、注射或其他）的预防潜力，计划 必须解决整个预防级联的不足——提高产后艾滋病毒检测率，减少 启动 PrEP 的障碍，并通过追踪违约者来提高 PrEP 护理的保留率。这项研究将测试 调动综合的、任务转移策略的干预措施，以提高 PrEP 的使用效率 马拉维的产后妇女。利用孕产妇参加早期婴儿疫苗接种就诊的机会，综合 干预措施部署有效的策略来增加艾滋病毒检测、促进合作伙伴参与、增强 获得口服或注射 PrEP，并让妇女接受 PrEP 护理。干预措施利用任务转移来 将 HIV 检测和 PrEP 服务纳入婴儿疫苗接种就诊中，并建立在高效的基础上 社区-设施联系模型“同伴”，将追踪范围扩大到包括 PrEP 违约者。在目标 1 中，调查人员 评估综合“产后预防包”干预措施的有效性，检查初级 母乳喂养妇女 12 个月时 PrEP 持续性的结果。次要结果包括 PrEP 摄取、PrEP 依从性和血清转化。目标 2 侧重于实施结果，检查保真度 产后妇女（其男性伴侣的一部分）对综合干预的接受程度， 诊所提供者和政策制定者。在目标 3 中，研究人员使用以下方法进行成本效益分析： 有效性结果和预期收集的成本、每次新的 PrEP 启动和每次的建模成本 保留在 PrEP 中的人。预算影响分析确定了成本驱动因素，并通知卫生部 人员配备和实施。如果成功地增加了 PrEP 的有效使用并且具有成本效益，那么这种干预措施 可以扩展到马拉维和整个撒哈拉以南非洲的其他诊所。

PROJECT SUMMARY Impressive progress has been made towards the ambitious goal of eliminating mother to child transmission (EMTCT) globally. In efficient EMTCT programs with high rates of ART uptake, an increasing proportion of new infant infections stem from incident maternal infections; in sub-Saharan Africa nearly one third of infant transmissions are linked to HIV infections that are acquired during pregnancy or breastfeeding. Driven by physiological shifts and behavioral changes, including resumption of condomless intercourse, the postpartum period is a particularly high-risk period for HIV acquisition. In Malawi, one-third of all new pediatric HIV infections are attributed to women who acquired HIV infection while breastfeeding. Improved postpartum HIV prevention is needed to prevent pediatric infections. One promising HIV prevention opportunity is HIV pre- exposure prophylaxis (PrEP). Taken as prescribed, daily oral PrEP effectively prevents HIV and is safe during breastfeeding. Unfortunately, uptake of and adequate adherence to PrEP among postpartum women in sub- Saharan Africa, including in Malawi, has been poor. Newer long-acting PrEP formulations, including injectable PrEP, is a promising and potentially paradigm shifting advance for HIV prevention, offering more discrete and convenient dosing. However, to maximize the prevention potential of PrEP (oral, injectable, or other), programs must address shortfalls across the prevention cascade –increasing rates of postpartum HIV testing, reducing barriers to PrEP initiation, and improving retention in PrEP care by tracing defaulters. This study will test an intervention that mobilizes an integrated, task-shifting strategy to improve effective PrEP use among postpartum women in Malawi. Leveraging maternal attendance at early infant vaccination visits, the integrated intervention deploys effective strategies to increase HIV testing, promote partner engagement, enhance access to oral or injectable PrEP, and retain women in PrEP care. The intervention uses task-shifting to integrate HIV testing and PrEP services into infant vaccination visits, and builds on the highly-effective community-facility linkage model “peers”, expanding tracing to include PrEP defaulters. In Aim 1, investigators evaluate the effectiveness the integrated “postpartum prevention package” intervention, examining primary outcome of PrEP persistence at 12 months among breastfeeding women. Secondary outcomes include PrEP uptake, PrEP adherence, and seroconversions. Aim 2 focuses on implementation outcomes, examining fidelity to and acceptability of the integrated intervention among postpartum women, a subset of their male partners, clinic providers, and policymakers. In Aim 3 investigators conduct a cost-effectiveness analysis using effectiveness outcomes and prospectively collected costs, modelling cost per new PrEP initiation and per person retained on PrEP. A budget impact analysis identifies drivers of cost, informing Ministry of Health staffing and implementation. If successful at increasing effective PrEP use and cost-effective, this intervention can be scaled to other clinics in Malawi and across sub-Saharan Africa.