Evaluating the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya

摘要 尽管在全面预防艾滋病毒母婴传播方面取得了进展 防止母婴传播(PMTCT)服务，在及时采用和提供遵守准则的服务方面存在重大差距 服务和产妇保育仍然存在。这种差距造成了错失的机会 防止母婴传播，导致近6100名婴儿感染 肯尼亚每年都有艾滋病毒携带者。有效的干预措施，使证据的交付常规化- 以预防母婴传播为基础的服务和培养一致的患者参与度对于结束 消除差距，消除艾滋病毒母婴传播。在成功的基础上构建 R34赠款用于开发和试点测试HITSystem 2.0，这是一种针对防止母婴传播的电子健康干预措施 服务，这项提议的总体目标是在12岁时使用集群随机对照设计 肯尼亚政府医院评估修改后的HITSystem 2.1干预措施。HIT系统 2.1反映2018年肯尼亚防止母婴传播准则，包括常规病毒载量监测和 抑制母体病毒载量的干预措施。我们的目标是评估HITSystem 2.1的影响 通过以下途径优化遵守准则的服务和病毒抑制 产前、分娩和产后早期。拟议研究的目标1将评估 HITSystem 2.1提高接受完全免疫的母亲比例的效果 预防母婴传播服务(包括预约就诊、药物依从性支持、病毒载量 根据肯尼亚国家指南进行的检测、基于医院的分娩和婴儿检测)至6 产后几个月。我们假设接受HITSystem 2.1干预的母亲将 与符合指南的预防母婴传播服务的完成率相比， 向接受标准护理的母亲提供预防母婴传播服务。在目标1b中，我们将评估HITSystem 2.1使用RE-AIM模式实施，为可持续扩大提供信息。目标2将评估 HITSystem 2.1提高孕妇病毒抑制率(&lt；1000拷贝/毫升)的效果 以及产后妇女，包括那些脱离护理的妇女。我们假设 HITSystem 2.1站点的母亲在分娩时和6将有更高的病毒抑制率 产后几个月。AIM 3将评估HITSystem 2.1的成本效益。驱动者 儿童HIV的母婴传播保留、病毒抑制和模型化估计的差异 为了避免感染，我们假设HITSystem 2.1将是经济高效的，基于 世界卫生组织标准。这项建议旨在提高防止母婴传播的质量。 卫生设施环境中的服务。如果有效且具有成本效益，HITSystem 2.1可以 为全国传播做出了强有力的承诺。

Abstract Despite progress in providing comprehensive prevention of mother-to-child transmission of HIV (PMTCT) services, significant gaps in the timely uptake and provision of guideline-adherent services and maternal retention in care remain. Such gaps create missed opportunities for preventing mother-to-child transmission and result in nearly 6,100 infants becoming infected with HIV each year in Kenya. Effective interventions that routinize the delivery of evidence- based PMTCT services and foster consistent patient engagement are essential to close the remaining gaps and eliminate mother-to-child transmission of HIV. Building off of a successful R34 grant to develop and pilot test the HITSystem 2.0, an eHealth intervention targeting PMTCT services, the overall goal of this proposal is to use a cluster randomized control design at 12 Kenyan government hospitals to evaluate a modified HITSystem 2.1 intervention. HITSystem 2.1 reflects the 2018 Kenyan PMTCT guidelines, including routine viral load monitoring and interventions to suppress maternal viral load. We aim to evaluate the impact of HITSystem 2.1 to optimize the provision of guideline-adherent services and viral suppression through the antenatal, delivery, and early postpartum periods. Aim 1 of the proposed study will assess the efficacy of the HITSystem 2.1 to increase the proportion of mothers who receive complete PMTCT services (including appointment attendance, medication adherence support, viral load testing, hospital-based delivery, and infant testing per Kenyan National Guidelines) through 6 months postpartum. We hypothesize that mothers receiving the HITSystem 2.1 intervention will have a significantly higher completion rate for guideline-adherence PMTCT services compared to mothers receiving standard of care PMTCT services. In Aim 1b, we will evaluate HITSystem 2.1 implementation using the RE-AIM model to inform sustainable scale up. Aim 2 will assess the efficacy of HITSystem 2.1 to increase viral suppression (<1,000 copies/mL) among pregnant and postpartum women, including those who disengage from care. We hypothesize that mothers at HITSystem 2.1 sites will have higher rates of viral suppression at delivery and 6 months postpartum. Aim 3 will evaluate the cost-effectiveness of the HITSystem 2.1. Driven by differences in PMTCT retention, viral suppression, and modeled estimates of pediatric HIV infections averted, we hypothesize that the HITSystem 2.1 will be cost-effective, based on World Health Organization criteria. This proposal is aimed at improving the quality of PMTCT services in the health facility setting. If efficacious and cost-effective, HITSystem 2.1 holds strong promise for national dissemination.