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

描述（由申请人提供）：为了消除新的儿科艾滋病毒感染，挽救孕产妇生命，并简化艾滋病毒普遍流行情况下的抗逆转录病毒治疗（ART）实施，目前世卫组织指南建议所有孕妇和哺乳期妇女终身接受三联ART（选项B+）。然而，尽管备选方案B+有望消除后勤障碍，并通过终身抗逆转录病毒疗法促进孕产妇健康，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疗法和继续接受艾滋病毒护理，特别是对那些自身健康不需要抗逆转录病毒疗法的妇女。在个人、人际、社区和卫生设施层面上，已经确定了坚持和继续接受预防母婴传播护理的障碍;但对方案B+背景下的具体障碍还没有很好的理解。我们的研究将在肯尼亚尼扬扎省的20个卫生机构和相关社区进行B，尽管广泛提供了预防母婴传播服务，但在方案B+推出之前，母婴传播率仍接近10%。随着备选方案B+在肯尼亚的推广，必须确定有效的方法，以确保在整个怀孕、母乳喂养及以后的期间长期坚持和保留对母婴的护理。基于我们团队在此背景下的先前研究经验，我们建议通过与艾滋病毒阳性孕妇和产后妇女，其男性伴侣和医疗保健提供者的形成性研究，了解并解决个人，社区和卫生设施层面的潜在障碍。这一信息将用于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提高艾滋病毒感染孕妇和艾滋病毒暴露婴儿的抗逆转录病毒治疗依从性和保留率。这些干预措施将在肯尼亚农村地区进行严格测试;使用随机分组2x2因子设计。有待测试的循证干预措施将包括：1）社区指导母亲（cMM），他们将为社区中艾滋病毒阳性妇女的抗逆转录病毒治疗依从性和继续护理提供支持; 2）个性化定制的、基于理论的移动的手机短信，以帮助妇女和婴儿继续接受艾滋病毒护理。我们的总体目标是确定在选项B+的背景下，哪种干预措施（或干预措施的组合）最大限度地提高抗逆转录病毒治疗的依从性和保留率，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个月的ART依从性和护理保留率，通过产后12个月前90天内记录的HIV护理访视来衡量。次要结局将包括6周、12个月和18个月时的母婴传播;以及母体病毒载量和CD 4计数。这项研究的结果将为在肯尼亚扩大方案B+提供信息，确定有效的干预措施和干预措施组合，减少障碍，增加最佳抗逆转录病毒治疗坚持和保留护理的促进因素，目的是消除艾滋病毒的母婴传播，显著改善孕产妇健康。

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.