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]

项目摘要 在实现消除母婴传播的宏伟目标方面取得了令人印象深刻的进展 （EMTCT）全球。在抗逆转录病毒疗法使用率高的有效消除母婴传播方案中， 婴儿感染源于偶然发生产妇感染;在撒哈拉以南非洲， 传播与怀孕或哺乳期间获得的艾滋病毒感染有关。驱动 生理变化和行为变化，包括恢复无避孕套性交，产后 经期是感染艾滋病毒的特别高风险时期。在马拉维，三分之一的儿童艾滋病毒感染者 感染的原因是妇女在哺乳期间感染了艾滋病毒。改善产后艾滋病毒 预防儿科感染是必要的。一个有希望的艾滋病毒预防机会是艾滋病毒预防前- 暴露预防（PrEP）。按规定服用，每日口服PrEP可有效预防HIV， 母乳喂养。不幸的是，在产后妇女中， 包括马拉维在内的撒哈拉非洲一直很贫穷。新型长效PrEP制剂，包括注射剂 PrEP是艾滋病毒预防的一个有希望和潜在的范式转变进展，提供了更多的离散和 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， 必须解决整个预防级联的不足之处-增加产后艾滋病毒检测率， 启动PrEP的障碍，并通过追踪违约者来提高PrEP护理的保留率。这项研究将测试一个 干预，动员一个综合的，任务转移战略，以提高有效的PrEP使用之间 马拉维的产后妇女。利用产妇在婴儿早期接种疫苗的机会， 干预措施部署了有效的战略，以增加艾滋病毒检测，促进伙伴参与， 获得口服或注射PrEP，并保留PrEP护理中的女性。干预使用任务转移， 将艾滋病毒检测和PrEP服务纳入婴儿疫苗接种访问， 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 评估综合“产后预防包”干预措施的有效性， 母乳喂养妇女中PrEP持续12个月的结果。次要结局包括PrEP 摄取、PrEP依从性和血清转化。目标2重点关注实施结果，检查保真度 产后妇女，其男性伴侣的一个子集， 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： 有效性结果和前瞻性收集的成本，每个新PrEP启动的建模成本和每个 预算影响分析确定了成本驱动因素，通知卫生部 人员配置和执行。如果成功地增加有效的PrEP使用和成本效益， 可以推广到马拉维和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.