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]

项目总结 在实现消除母婴传播这一宏伟目标方面取得了令人印象深刻的进展 (EMTCT)全球。在高效的抗逆转录病毒治疗方案中，越来越多的新患者 婴儿感染源于意外孕产妇感染；在撒哈拉以南非洲，近三分之一的婴儿 传播与怀孕或哺乳期间感染艾滋病毒有关。驱动者 生理变化和行为变化，包括恢复无套性交、产后 这一时期是艾滋病毒感染的特别高风险时期。在马拉维，三分之一的新的儿科艾滋病毒 感染归因于在母乳喂养期间感染艾滋病毒的妇女。改进的产后艾滋病毒 预防儿科感染需要预防。一个有希望的艾滋病毒预防机会是艾滋病毒前期 暴露预防(PrEP)。按处方服用，每日口服PrEP可有效预防艾滋病毒，并在 母乳喂养。不幸的是，产后妇女对PrEP的接受和足够的依从性 撒哈拉非洲，包括马拉维，一直很贫穷。较新的长效PrEP制剂，包括注射剂 PREP，是艾滋病毒预防的一个有前途的和潜在的范式转变的进步，提供了更离散和 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 PrEP启动的障碍，并通过追踪违约者改善PrEP护理中的保留率。这项研究将测试一个 采取干预措施，调动综合的任务转移战略，提高PrEP的有效使用 马拉维的产后妇女。利用产妇在早期婴儿疫苗接种访问中的参与，综合 干预部署了有效的战略，以增加艾滋病毒检测，促进合作伙伴的参与，增强 获得口服或注射PrEP，并将妇女保留在PrEP护理中。干预使用任务转移来 将艾滋病毒检测和PrEP服务整合到婴儿疫苗接种访问中，并在高效 社区-设施联系模式“同行”，扩大追踪范围，将PrEP违约者包括在内。在目标1中，调查人员 产后综合预防包干预效果评价，初诊 哺乳妇女持续12个月PrEP的结果。次要结果包括PrEP 摄取、PrEP依从性和血清转化率。目标2侧重于实施成果，检查保真度 产后妇女及其男性伴侣的综合干预的接受度和接受度， 诊所提供者和决策者。在AIM 3中，调查人员使用以下工具进行成本效益分析 有效性结果和预期收集的成本、每个新的PrEP启动和PER的建模成本 保留在PrEP上的人。预算影响分析确定成本驱动因素，通知卫生部 人员配置和执行情况。如果成功地提高了PrEP的有效使用率和成本效益，这种干预措施 可以推广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.