Comparative Effectiveness of Congregation and Clinic Based Approaches to PMTCT

描述（由申请人提供）：世界卫生组织确定了22个优先国家，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方案，但只有14%的孕妇接受了艾滋病毒检测; 9%的艾滋病毒感染孕妇接受了世卫组织推荐的抗逆转录病毒治疗;只有11%的艾滋病毒暴露婴儿接受了预防母婴艾滋病毒传播的抗逆转录病毒预防治疗，导致2010年估计有75，000名艾滋病毒感染婴儿。目前，大多数孕妇必须进入医疗机构（HF）进行筛查，并接受可用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%的孕妇在HF中分娩，只有2.9%的HF有既定的PMTCT计划。如果我们要实现“总统艾滋病紧急救援计划”到2015年使孕妇艾滋病毒筛查率达到80%的目标，就必须找到新的办法，将循证的预防母婴传播方案转化为以社区为基础的环境。在皮尤中心调查的53个国家中，尼日利亚在教堂出席率方面排名第一。每个社区至少有一个宗教机构，这提供了一个独特的机会，可以评估以教会为基础的孕妇及其男性伴侣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防止母婴传播干预措施的效果。因此，我们提出了一个集群随机试验，以评估的比较有效性的一个集合为基础的健康开始倡议提供的奠定健康顾问（干预组; IG），与诊所为基础的方法（对照组; CG）的艾滋病毒检测率和PMTCT完成2700名孕妇。尼日利亚东南部的40个教会将被随机分配（1：1）到IG或CG。健康开端倡议结合了家庭教育游戏节目和在婴儿送礼会上提供的综合现场实验室测试。每月为孕妇举行的祈祷会将用于招募，婴儿洗礼后的婴儿接待将用于分娩后的后续行动。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艾滋病毒检测率和艾滋病毒感染孕妇预防母婴传播完成率的差异。孕妇将填写一份由医务人员管理的问卷，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。自我报告的数据将通过现场检测数据和HF进行确认。这项建议是预防、教育、培训、治疗和研究伙伴（PetR-全球解决方案）/艾滋病方案伙伴（我们在尼日利亚的总统艾滋病紧急救援计划资助的伙伴，负责培训、艾滋病毒检测、与治疗的联系和项目的地方监督）之间的合作; 纽约大学医学院（项目评价并与PI共同监督）、董事会、NSHE、内华达州奥博大学、里诺（提供总体监督、数据管理和项目有效性评价）。

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).