Comparative Effectiveness of Congregation and Clinic Based Approaches to PMTCT

描述（由申请人提供）：世卫组织确定了22个重点国家，这些国家占感染艾滋病毒的孕妇的90%。尼日利亚是22个国家中仅有的4个孕妇艾滋病毒检测率低于20%的国家之一。尽管尼日利亚扩大了艾滋病毒预防项目，但只有14%的孕妇接受了艾滋病毒检测；9%感染艾滋病毒的孕妇接受了世卫组织推荐的抗逆转录病毒治疗；只有11%的暴露于艾滋病毒的婴儿接受了抗逆转录病毒药物预防，以防止母婴艾滋病毒传播（PMTCT），导致2010年估计有75 000名婴儿感染艾滋病毒。目前，大多数孕妇必须前往医疗机构（HF）接受筛查，并接受现有的预防母婴传播干预措施。这种基于临床的方法具有挑战性，因为只有35%的心衰孕妇分娩，只有2.9%的心衰孕妇有建立的预防母婴传播计划。如果我们要实现总统防治艾滋病紧急救援计划到2015年将孕妇艾滋病毒筛查率提高到80%的目标，就必须找到新的方法，将循证预防母婴传播项目转化为社区环境。在皮尤中心调查的53个国家中，尼日利亚的教会出席率排名第一。每个社区至少有一个以信仰为基础的机构，这就提供了一个独特的机会，可以评估在孕妇及其男性伴侣中开展以会众为基础的艾滋病毒检测方法的效果，以及在感染艾滋病毒的孕妇中完成预防母婴传播干预的效果。因此，我们提出了一项集群随机试验，以评估由非专业健康顾问（干预组；IG）提供的以会众为基础的健康开端倡议与以诊所为基础的方法（对照组；CG）在2700名孕妇中艾滋病毒检测率和预防母婴传播完成情况的比较效果。尼日利亚东南部的四十个教堂将随机分配（1:1）给总主教或总主教。“健康的开端”倡议结合了家庭教育游戏节目和在婴儿派对背景下提供的综合现场实验室测试。每月为孕妇祈祷会将用于招募，婴儿洗礼后的婴儿接待将用于分娩后的随访。主要结果是两组之间艾滋病毒检测率的差异。次要结果是两组男性伴侣的艾滋病毒检测率和感染艾滋病毒的孕妇的预防母婴传播完成率的差异。孕妇将完成一份由调查人员管理的问卷，以收集有关艾滋病毒检测和预防母婴传播完成情况的信息。自报数据将与现场测试数据及HF进行确认。该提案是预防、教育、培训、治疗和研究伙伴（全球解决方案）/艾滋病救济（我们在尼日利亚的pepfar资助伙伴，将负责培训、艾滋病毒检测、与治疗的联系以及项目的地方监督）；

DESCRIPTION (provided by applicant): Twenty-two priority countries have been identified by the WHO that account for 90% of pregnant women living with HIV. Nigeria is one of only 4 countries among the 22 with an HIV testing rate for pregnant women of less than 20%. Despite expansions of HIV prevention programs in Nigeria, only 14% of pregnant women were tested for HIV; while 9% of pregnant women living with HIV received WHO recommended antiretroviral (ARV) therapy; and only 11% of HIV-exposed infants received ARV prophylaxis for prevention of mother-to-child HIV transmission (PMTCT) resulting in an estimated 75,000 HIV-infected infants in 2010. Currently, most pregnant women must access a healthcare facility (HF) to be screened and receive available PMTCT interventions. This clinic-based approach is challenging when only 35% of pregnant women deliver in a HF and only 2.9% of HF have an established PMTCT program. Finding new approaches to translate evidence-based PMTCT programs to community-based setting is necessary if we are to realize the PEPFAR goal of 80% HIV screening rate among pregnant women by 2015. Nigeria is ranked #1 among 53 nations surveyed by Pew Center in church attendance. The availability of at least one faith-based institution in each community presents a unique opportunity to evaluate the effect of a congregation-based approach to HIV testing among pregnant women, and their male partners as well as completion of PMTCT interventions among HIV-infected pregnant women. Thus we propose a cluster randomized trial to evaluate the comparative effectiveness of a congregation-based Healthy Beginning Initiative delivered by lay health advisors (Intervention Group; IG), versus a clinic-based approach (Control Group; CG) on the HIV testing rate and PMTCT completion among 2700 pregnant women. Forty churches in South-east Nigeria will be randomly assigned (1:1) to either the IG or the CG. The Healthy Beginning Initiative combines a family educational game show and an integrated on-site laboratory testing delivered in the context of a baby shower. Monthly prayer sessions for pregnant women will be used for recruitment and baby receptions following infant baptisms will be used for follow up after delivery. The primary outcome is the difference in HIV testing rate between both groups. The secondary outcomes are the difference in HIV testing rate among male partners and PMTCT completion rate among HIV-infected pregnant women for both groups. Pregnant women will complete an investigator-administered questionnaire to collect information on HIV testing and PMTCT completion. Self-reported data will be confirmed with on-site testing data and HF. This proposal is a collaboration among Partners for Prevention, Education, Training, Treatment and Research (PeTR-Global Solutions)/AIDSRelief (our PEPFAR-funded partner in Nigeria who will be responsible for training, HIV testing, linkage to treatment and local oversight of the project); New York University School of Medicine (program evaluation and shares oversight with PI), Board of Regents, NSHE, obo University of Nevada, Reno (provide overall oversight, data management and evaluation of program effectiveness). PUBLIC HEALTH RELEVANCE: Interventions targeted at increasing the rate of HIV testing among pregnant women and their male partners are urgently needed to address the epidemic of mother-to-child HIV transmission and its associated morbidity, mortality and societal costs in Sub-Saharan Africa. Using a cluster randomized trial design among 2700 pregnant women followed in 40 churches in Nigeria, the goal of the proposed study is to evaluate the comparative effectiveness of a congregation-based versus clinic-based approach on HIV testing and PMTCT completion rates. Findings from this study will provide policy makers and funding agencies needed information on effective, sustainable community-based approaches to increase HIV testing among pregnant women and their male partners.