Maximizing adherence /retention for women /infants in the context of Option B+, Kenya

描述(由申请人提供)：为了消除新的儿童艾滋病毒感染，挽救产妇的生命，并在艾滋病毒普遍流行的情况下简化抗逆转录病毒疗法(ART)的实施，世卫组织目前的指南建议对所有孕妇和哺乳妇女实施终身三重抗逆转录病毒疗法(备选方案B+)。然而，尽管方案B+承诺消除后勤障碍，并通过终身艺术促进孕产妇健康，但这一战略带来了挑战。这些挑战中的关键是坚持抗逆转录病毒治疗和持续保留艾滋病毒护理，特别是对于不需要抗逆转录病毒治疗的妇女。已在个人、人际、社区和卫生设施一级查明了遵守和保留预防母婴传播护理(母婴传播)的障碍；然而，备选方案B+方面的具体障碍还没有得到很好的理解。我们的研究将在肯尼亚Nyanza省的20个卫生机构和相关社区进行，尽管预防母婴传播服务广泛可用，但在备选方案B+推出之前，那里的母婴传播率保持在近10%。随着备选方案B+在肯尼亚的推广，至关重要的是确定有效的方法，以确保在整个怀孕、哺乳和以后的整个过程中长期坚持和保留照顾母婴对。基于我们团队以前在这方面的研究经验，我们建议通过对HIV阳性孕妇和产后妇女、她们的男性伴侣和医疗保健提供者进行形成性研究，了解并解决个人、社区和卫生设施层面的潜在障碍。这些信息将被用来完善两项拟议的干预措施，这两项干预措施极有可能最大限度地遵守和保留感染艾滋病毒的孕妇和感染艾滋病毒的婴儿的护理。这些干预措施将在肯尼亚农村进行严格的测试；采用整群随机2x2析因设计。将被测试的循证干预措施将包括1)社区指导母亲(CMM)，她们将为社区艾滋病毒阳性妇女的抗逆转录病毒治疗的坚持和保留提供支持，以及2)个人定制的、基于理论的手机短信，以帮助将妇女和婴儿保留在艾滋病毒护理中。我们的总体目标是确定哪种干预措施(或干预措施的组合)在备选方案B+的背景下最大限度地遵守和保留抗逆转录病毒治疗，从而改善孕产妇和婴儿的健康结果。我们的主要结果将包括产后12个月坚持抗逆转录病毒治疗和保留护理，通过产后12个月前90天内有记录的艾滋病毒护理访问来衡量。次要结果将包括6周、12个月和18个月的母婴传播；以及母亲的病毒载量和CD4计数。这项研究的结果将通过确定有效的干预措施和干预措施的组合，在肯尼亚扩大备选方案B+的规模，这些干预措施可以减少障碍，增加最佳抗逆转录病毒疗法的遵守和保留护理的促进者，目的是实现消除艾滋病毒母婴传播的目标，并显著改善产妇健康。

DESCRIPTION (provided by applicant): In order to eliminate new pediatric HIV infections, save maternal lives, and simplify antiretroviral therapy (ART) implementation in settings with generalized HIV epidemics, current WHO guidance recommends lifelong triple ART for all pregnant and breastfeeding women (Option B+). However, despite the promise of Option B+ to remove logistical barriers and to promote maternal health through life-long ART, this strategy brings challenges. Key amongst these challenges is adherence to ART and continuous retention in HIV care, especially for women who do not require ART for their own health. Barriers to adherence and retention in care for prevention of mother-to-child transmission (PMTCT) have been identified at the individual, interpersonal, community, and health facility levels; yet specific barriers in the context of Option B+ are not well understood. Our study will b conducted at 20 health facilities and associated communities in Nyanza Province, Kenya where MTCT rates prior to Option B+ roll-out remained near 10%, despite the wide availability of PMTCT services. As Option B+ is scaled up in Kenya, it is essential to identify effective methods to ensure long-term adherence and retention in care for mother-baby pairs, throughout pregnancy, breastfeeding, and beyond. Building on our team's prior research experience in this setting, we propose to gain understanding of and address potential barriers at the individual, community, and health facility levels through formative research with HIV-positive pregnant and postpartum women, their male partners, and health care providers. This information will be used to refine two proposed interventions that are highly likely to maximize ART adherence and retention in care among HIV-infected pregnant women and HIV-exposed infants. These interventions will be rigorously tested in rural Kenya; using a cluster randomized 2x2 factorial designs. The evidence-based interventions to be tested will include 1) community Mentor Mothers (cMM) who will provide support for ART adherence and retention in care for HIV-positive women in the community and 2) individually tailored, theory- based mobile phone text messages to help retain women and infants in HIV care. Our overall goal is to determine which intervention (or combination of interventions) maximizes ART adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes. Our primary outcomes will include ART adherence at 12 months postpartum and retention in care, measured by a documented HIV care visit within 90 days prior to 12 months postpartum. Secondary outcomes will include MTCT at 6 weeks, 12 months and 18 months; as well as maternal viral loads and CD4 counts. Results from this study will inform the scale-up of Option B+ in Kenya by identifying effective interventions and combinations of interventions that can reduce barriers and increase facilitators of optimal ART adherence and retention in care with the aims of reaching the elimination of mother to child transmission of HIV and significantly improving maternal health.