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.

抽象的尽管在提供全面预防艾滋病毒的母亲传播方面取得了进展（PMTCT）服务，在及时采用和提供指南遵守方面的巨大差距保留服务和孕产妇保留。这样的差距为错过的机会防止母亲到孩子的传播，并导致近6100名受孕每年在肯尼亚有艾滋病毒。有效的干预措施常规化证据 - 基于PMTCT服务和寄养一致的患者参与对于关闭剩余的差距并消除了艾滋病毒的母亲传播。成功建立 R34赠款开发和试点测试HITSYSTEM 2.0，这是针对PMTCT的EHEADH干预措施服务，该提案的总体目标是在12时使用群集随机控制设计肯尼亚政府医院评估修改后的HITSYSTEM 2.1干预。 HITSYSTEM 2.1反映了2018年肯尼亚PMTCT指南，包括常规的病毒负荷监测和抑制母体病毒负荷的干预措施。我们旨在评估HITSYSTEM 2.1的影响通过优化提供指南遵守服务和病毒抑制的提供产前和产后早期时期。拟议研究的目标1将评估 HITSYSTEM 2.1的疗效增加接受完整的母亲的比例 PMTCT服务（包括预约出勤，药物依从性支持，病毒负荷根据肯尼亚国家指南的测试，基于医院的分娩和婴儿测试）产后月。我们假设接受HITSYSTEM 2.1干预的母亲将比较指南遵守PMTCT服务的完成率明显更高给获得护理标准PMTCT服务的母亲。在AIM 1B中，我们将评估HITSYSTEM 2.1使用RE-AIM模型实施为可持续规模提供信息。 AIM 2将评估 HITSYSTEM 2.1的功效增加了孕妇的病毒抑制（<1,000份/ml）和产后妇女，包括那些脱离护理的人。我们假设这一点 HITSYSTEM 2.1站点的母亲将在分娩时具有更高的病毒抑制率和6个产后月。 AIM 3将评估HITSYSTEM 2.1的成本效益。由 PMTCT保留，病毒抑制和小儿HIV的估计值的差异避免感染，我们假设HITSYSTEM 2.1将具有成本效益世界卫生组织标准。该建议旨在提高PMTCT的质量医疗机构设置的服务。如果有效且具有成本效益，则HITSYSTEM 2.1保持民族传播的强烈希望。