Department of Global Health, University of Washington Schools of Medicine and Public Health, 1705 NE Pacific St, Seattle, WA 98195, USA.
Implement Sci. 2014 May 8;9:55. doi: 10.1186/1748-5908-9-55.
Despite significant increases in global health investment and the availability of low-cost, efficacious interventions to prevent mother-to-child HIV transmission (pMTCT) in low- and middle-income countries with high HIV burden, the translation of scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. A five-step, facility-level systems analysis and improvement intervention (SAIA) was designed to maximize effectiveness of pMTCT service provision by improving understanding of inefficiencies (step one: cascade analysis), guiding identification and prioritization of low-cost workflow modifications (step two: value stream mapping), and iteratively testing and redesigning these modifications (steps three through five). This protocol describes the SAIA intervention and methods to evaluate the intervention's impact on reducing drop-offs along the pMTCT cascade.
This study employs a two-arm, longitudinal cluster randomized trial design. The unit of randomization is the health facility. A total of 90 facilities were identified in Côte d'Ivoire, Kenya and Mozambique (30 per country). A subset was randomly selected and assigned to intervention and comparison arms, stratified by country and service volume, resulting in 18 intervention and 18 comparison facilities across all three countries, with six intervention and six comparison facilities per country. The SAIA intervention will be implemented for six months in the 18 intervention facilities. Primary trial outcomes are designed to assess improvements in the pMTCT service cascade, and include the percentage of pregnant women being tested for HIV at the first antenatal care visit, the percentage of HIV-infected pregnant women receiving adequate prophylaxis or combination antiretroviral therapy in pregnancy, and the percentage of newborns exposed to HIV in pregnancy receiving an HIV diagnosis eight weeks postpartum. The Consolidated Framework for Implementation Research (CFIR) will guide collection and analysis of qualitative data on implementation process.
This study is a pragmatic trial that has the potential benefit of improving maternal and infant outcomes by reducing drop-offs along the pMTCT cascade. The SAIA intervention is designed to provide simple tools to guide decision-making for pMTCT program staff at the facility level, and to identify low cost, contextually appropriate pMTCT improvement strategies.
ClinicalTrials.gov NCT02023658.
尽管在艾滋病毒负担高的中低收入国家，全球卫生投资显著增加，并且有了低成本、有效的干预措施来预防母婴传播艾滋病毒（pMTCT），但将科学进步转化为有效的提供策略的进展一直缓慢、不均衡且不完整。因此，儿科艾滋病毒感染仍然基本未得到控制。设计了一个五步、设施层面的系统分析和改进干预措施（SAIA），旨在通过提高对效率低下的理解来最大限度地提高 pMTCT 服务提供的效果（第一步：级联分析），指导确定和优先考虑低成本工作流程修改（第二步：价值流映射），并迭代测试和重新设计这些修改（第三至五步）。本方案描述了 SAIA 干预措施以及评估干预措施对减少 pMTCT 级联中断的影响的方法。
本研究采用了两臂、纵向聚类随机试验设计。随机单位是卫生机构。在科特迪瓦、肯尼亚和莫桑比克共确定了 90 个机构（每个国家 30 个）。随机选择了一个子集，并按国家和服务量进行分层，分配到干预组和对照组，结果在所有三个国家共 18 个干预机构和 18 个对照组，每个国家 6 个干预组和 6 个对照组。SAIA 干预措施将在 18 个干预机构中实施六个月。主要试验结果旨在评估 pMTCT 服务级联的改善情况，包括在第一次产前保健就诊时接受 HIV 检测的孕妇比例、接受充分预防或联合抗逆转录病毒治疗的 HIV 感染孕妇比例以及在妊娠期间接触 HIV 的新生儿接受 HIV 诊断的比例在产后八周。实施研究综合框架（CFIR）将指导收集和分析实施过程的定性数据。
本研究是一项实用试验，有可能通过减少 pMTCT 级联中的中断来改善母婴结局。SAIA 干预措施旨在为设施层面的 pMTCT 计划工作人员提供简单的工具，以指导决策，并确定低成本、符合当地情况的 pMTCT 改进策略。
ClinicalTrials.gov NCT02023658。
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