GH12-008: Community Home Based India Prevention of Mother To Child Transmission study

总结 为了解决印度感染艾滋病毒的母亲和儿童的沉重负担， 该组织和马哈拉施特拉邦艾滋病控制协会正在准备实施 2010年修订的世界卫生组织（世卫组织）预防艾滋病毒母婴传播（PMTCT） 2012年4月的指导方针。印度最新的预防母婴传播方案有四个主要组成部分： 向所有感染艾滋病毒的孕妇和哺乳母亲提供抗逆转录病毒治疗; 2）促进 纯母乳喂养6个月; 3）给予6周延长的奈韦拉平预防（SWEN） 4）让妇女和婴儿参与并保留产后艾滋病毒护理， 有利于婴儿早期诊断。 我们研究的总体目标是评估一种战略性、综合性和创新性的方法， 外展工作者到病人家中探访，以支持接受预防母婴传播服务。我们 干预，基于一个创新的适应性的信息，动机，行为技能模型， 护理启动和维持（sIMB-CIM），被称为社区基于家庭的预防母婴传播（COMBIND 预防母婴传播）的研究，并有以下四个战略：1）专门的ORW培训，包括评估 知识保留，并提供有针对性的再培训; 2）向ORW提供战略反馈，以提高其 3）向母亲提供有针对性的反馈，以加强对4项具体服务的利用;以及4）使用 开源、屡获殊荣的移动的健康（mHealth）平台（eMOCHA），可促进与 ORW和患者，为提供者，患者和计划提供战略反馈，并优化 预防母婴传播的四个关键要素核心假设是，提出的干预措施将导致优化的 4个关键预防母婴传播组件中的每个组件的计划实施。 COMBIND研究的具体目的是：1）检查COMBIND PMTCT对摄取 纳科的PMTCT计划的四个主要组成部分，在四个高艾滋病毒感染者中使用群集随机试验设计， 马哈拉施特拉邦的负担地区; 2）对干预措施进行混合方法评价，以评估影响 建议的ORW和妇女有针对性的反馈系统的可接受性， mHealth平台。我们的研究成功的可能性很高，因为我们的合作，跨学科， 机构间印美研究小组包括一个非政府组织Lakshya，它小组 成员在临床和实施科学项目方面有多年的经验; MSACS， 卫生部领导马哈拉施特拉邦的艾滋病毒/艾滋病方案;约翰霍普金斯大学 该大学与印度浦那的Lakshya和BJ医学院有现有的印美合作， 在临床和实施科学项目的合作研究方面拥有丰富的经验。

Summary To address the significant burden of HIV-infected mothers and children in India, the National AIDS Control Organization (NACO) and Maharashtra State AIDS Control Society (MSACS) are preparing to implement the 2010 revised World Health Organization (WHO) prevention of mother-to-child HIV transmission (PMTCT) guidelines in April 2012. This updated PMTCT program in India has four major components: 1) Provision of antiretroviral treatment (ART) to all HIV-infected pregnant women and breastfeeding mothers; 2) Promotion of exclusive breastfeeding for 6 months; 3) Administration of six weeks extended nevirapine prophylaxis (SWEN) to all HIV-exposed infants and 4) Engagement and retention of women and infants in postpartum HIV care to facilitate early infant diagnosis. The overall goal of our study is to evaluate a strategic, integrated and innovative approach to improve the capacity of outreach workers (ORWs) visiting patients in their homes, to support uptake of PMTCT services. Our intervention, based on an innovative adaptation of an situated information-motivation-behavioral skills model of care initiation and maintenance (sIMB-CIM), is called COMmunity home Based INDia PMTCT (COMBIND PMTCT) study and has the following four strategies: 1) Specialized ORW training that includes assessments of knowledge retention and provides targeted re-training; 2) Strategic feedback to ORWs, to improve their performance; 3) Targeted feedback to mothers to enhance uptake of the 4 specific services; and 4) Use of an open-source, award-winning mobile health (mHealth) platform (eMOCHA) that facilitates communication with ORWs and patients, provides strategic feedback to the providers, patients and program, and optimizes uptake of the 4 key PMTCT components. The central hypothesis is that intervention proposed will result in optimized program implementation in each of the 4 key PMTCT components. The specific aims of the COMBIND study are: 1) To examine the impact of COMBIND PMTCT on uptake of the four major components of NACO's PMTCT program, using a cluster randomized trial design in four high-HIV burden districts of Maharashtra ; 2) Conduct a mixed-methods evaluation of the intervention to assess the impacts and acceptability of the proposed targeted feedback system for both ORWs and women and use and feasibility of the mHealth platform. Our study has a high likelihood of success because our collaborative, interdisciplinary, inter-institution Indo-US research team include Lakshya, a non-governmental organization (NGO) whose team members have several years of experience in clinical and implementation science projects; MSACS, a division of the Ministry of Health that provides leadership to HIV/AIDS program in Maharashtra State; and Johns Hopkins University, that has existing Indo-US collaboration with Lakshya and BJ Medical College, Pune, India and has extensive experience in collaborative research in clinical and implementation science projects.