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

评估 HIT 系统以改善肯尼亚 PMTCT 保留和母体病毒抑制

基本信息

批准号：
10533783
负责人：
SARAH Finocchario KESSLER
金额：
$ 62.36万
依托单位：
UNIVERSITY OF KANSAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-12-18 至 2024-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10533783
关键词：
2 arm randomized control trial AIDS prevention Acquired Immunodeficiency Syndrome Address Adoption Appointment Breast Feeding Caring Cessation of life Childhood Clinical Country Data Documentation Effectiveness Enrollment Ensure Fostering Goals Government Grant Guideline Adherence Guidelines HIV HIV Infections HIV Seropositivity HIV diagnosis Health care facility High Prevalence Hospitals Human immunodeficiency virus test Infant Interruption Intervention Kenya Life Maintenance Maternal Health Measures Modeling Monitor Mother-to-child HIV transmission Mothers Online Systems Participant Perinatal transmission Postpartum Period Postpartum Women Pregnancy Pregnant Women Prevention Provider Proxy Randomized Randomized, Controlled Trials Reach, Effectiveness, Adoption, Implementation, and Maintenance Regimen Resources Sampling Schedule Services Site System Technology Test Result Testing Text Messaging Time Update Vertical Disease Transmission Viral Viral Load result Visit Woman World Health Organization antenatal antiretroviral therapy arm clinical care cost cost effective cost effectiveness cost-effectiveness evaluation design eHealth early pregnancy effective intervention efficacy evaluation evidence base follow-up high risk implementation fidelity improved medication compliance patient engagement patient retention pediatric human immunodeficiency virus infection perinatal HIV pilot test prevent prospective public health relevance scale up service delivery standard of care success therapy development transmission process uptake web-based intervention

项目摘要

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.

抽象的尽管在全面预防艾滋病毒母婴传播方面取得了进展（PMTCT）服务，在及时采用和提供遵守指南方面存在重大差距服务和孕产妇保留护理仍然存在。这种差距导致错失机会防止母婴传播，导致近6,100名婴儿被感染肯尼亚每年都有艾滋病毒感染者。使证据交付常规化的有效干预措施基于 PMTCT 服务并促进一致的患者参与对于关闭弥补差距并消除艾滋病毒母婴传播。建立在成功的基础上 R34 拨款用于开发和试点测试 HITSystem 2.0，这是一项针对 PMTCT 的电子卫生干预措施服务，该提案的总体目标是在 12 处使用集群随机控制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 反映了 2018 年肯尼亚 PMTCT 指南，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 的影响通过以下方式优化提供符合指南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 提高接受完全生育的母亲比例的功效 PMTCT 服务（包括预约出勤、药物依从性支持、病毒载量根据肯尼亚国家指南进行检测、医院分娩和婴儿检测）至 6 产后几个月。我们假设接受 HITSystem 2.1 干预的母亲会相比之下，遵循指南的 PMTCT 服务的完成率明显更高接受标准护理 PMTCT 服务的母亲。在目标 1b 中，我们将评估 HITSystem 2.1 使用 RE-AIM 模型实施，为可持续规模扩大提供信息。目标 2 将评估 HITSystem 2.1 增强孕妇病毒抑制（<1,000 拷贝/mL）的功效以及产后妇女，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的病毒抑制率更高，并且 6 产后几个月。目标 3 将评估 HITSystem 2.1 的成本效益。驱动力 PMTCT 保留、病毒抑制和儿科 HIV 模型估计的差异避免感染，我们假设 HITSystem 2.1 将具有成本效益，基于世界卫生组织标准。该提案旨在提高 PMTCT 的质量医疗机构环境中的服务。如果有效且具有成本效益，HITSystem 2.1 成立对全国传播的强烈承诺。