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

• 批准号: 10311079
• 负责人: SARAH Finocchario KESSLER
• 金额: $ 63.02万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 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/10311079
• 关键词: 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; Patients; 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; base; clinical care; 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; 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

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.

摘要 尽管在全面预防母婴传播艾滋病毒方面取得了进展， （预防母婴传播）服务，在及时接受和提供符合准则的 服务和产妇继续接受护理的情况依然存在。这些差距造成错失机会， 防止母婴传播，导致近6,100名婴儿感染 每年在肯尼亚感染艾滋病病毒。有效的干预措施，使证据的提供更加合理化- 基于PMTCT服务和促进一致的患者参与对于关闭 消除艾滋病毒的母婴传播。建立一个成功的 R34赠款用于开发和试点测试HIT系统2.0，这是一项针对预防母婴传播的电子保健干预措施 服务，本提案的总体目标是使用12个 肯尼亚政府医院评估修改后的HIT系统2.1干预措施。HIT系统 2.1反映了2018年肯尼亚预防母婴传播指南，包括常规病毒载量监测， 采取干预措施，抑制母体病毒载量。我们的目标是评估HIT系统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 保健信息技术系统2.1在增加获得完整保健服务的母亲比例方面的功效 预防母婴传播服务（包括预约出勤、药物依从性支持、病毒载量 检测、住院分娩和婴儿检测（根据肯尼亚国家指南） 产后数月。我们假设接受HITSystem 2.1干预的母亲将 有一个显着更高的完成率为遵循指南的预防母婴传播服务相比， 向接受预防母婴传播标准护理服务的母亲提供服务。在目标1b中，我们将评估HIT系统 2.1使用RE-AIM模型实施，为可持续的规模扩大提供信息。目标2将评估 HITSystem 2.1在孕妇中增加病毒抑制（<1，000拷贝/mL）的有效性 和产后妇女，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， 产后数月。目标3将评估HIT系统2.1的成本效益。驱动 PMTCT保留、病毒抑制和儿科HIV模型估计值的差异 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。该建议旨在提高预防母婴传播的质量 卫生设施中的服务。如果有效且具有成本效益，则HIT系统2.1适用 在全国范围内大力推广。