Comparative Effectiveness of Congregation and Clinic Based Approaches to PMTCT

基于会众和临床的 PMTCT 方法的比较效果

• 批准号: 8551683
• 负责人: Echezona Edozie Ezeanolue
• 金额: $ 44.48万
• 依托单位: UNIVERSITY OF NEVADA RENO
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-30 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8551683
• 关键词: AIDS prevention; Accounting; Address; Africa South of the Sahara; Anti-Retroviral Agents; Caring; Child; Childhood; Church; Clinic; Clinical Trials Design; Collaborations; Communities; Control Groups; Country; Data; Effectiveness; Epidemic; Evaluation; Family; Funding; Funding Agency; Goals; HIV; Health; Health care facility; Health system; Human immunodeficiency virus test; Individual; Infant; Infection; Institution; Intervention; Laboratories; Life; Maternal and Child Health; Modeling; Morbidity - disease rate; Mothers; Nevada; New York; Nigeria; Outcome; Patient Self-Report; Penetration; Play; Policy Maker; Prayers; Pregnant Women; Prevention; Prevention approach; Prevention education; Prevention program; Preventive Intervention; Program Effectiveness; Program Evaluation; Prophylactic treatment; Questionnaires; Randomized; Regimen; Research; Research Personnel; Resources; Role; Site; Solutions; Surveys; Testing; Training; Translating; Universities; Vertical Disease Transmission; Woman; antiretroviral therapy; base; comparative effectiveness; cost; data management; evidence base; follow-up; group intervention; improved; male; medical schools; mortality; novel strategies; primary outcome; programs; public health relevance; randomized trial; scale up; screening; secondary outcome; social; transmission process

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).

描述（由申请人提供）：占艾滋病毒孕妇的孕妇90％的WHO已确定了22个优先国家。尼日利亚是22个国家中仅有的4个国家之一，孕妇的艾滋病毒测试率不到20％。尽管尼日利亚的艾滋病毒预防计划扩大，但只有14％的孕妇接受了艾滋病毒的测试。尽管有9％的艾滋病毒孕妇接受了抗逆转录病毒（ARV）治疗的孕妇；只有11％的艾滋病毒暴露婴儿获得了预防预防母亲到儿童艾滋病毒传播（PMTCT）的ARV预防，导致2010年估计有75,000名HIV感染的婴儿。目前，大多数孕妇必须获得医疗保健设施（HF）（HF）以进行筛查并接受PMTCT干预措施。当只有35％的孕妇在HF中提供HF，而HF只有2.9％的PMTCT计划，这种基于诊所的方法是具有挑战性的。如果我们要在2015年意识到孕妇的80％艾滋病毒筛查率的PEPFAR目标，则必须找到将基于证据的PMTCT计划转化为基于社区的环境的新方法。尼日利亚在Pew Center在教堂出席中接受调查的53个国家中排名第一。每个社区中至少有一个基于信仰的机构的可用性为评估孕妇及其男性伴侣的基于会众的艾滋病毒测试方法的影响以及在艾滋病毒感染的孕妇中完成PMTCT干预措施的效果。因此，我们提出了一项集群随机试验，以评估外行健康顾问（Issestention Group; IG）提供的基于会众的健康开始计划的比较有效性，而基于诊所的方法（对照组； CG）对2700名孕妇的HIV测试率和PMTCT完成。尼日利亚东南部的四十个教堂将被随机分配（1：1）到IG或CG。健康的开始计划结合了家庭教育游戏节目和在婴儿洗澡背景下进行的集成现场实验室测试。孕妇的每月祈祷会议将用于招募，婴儿洗礼后的婴儿招待会将用于随访。主要结果是两组之间的艾滋病毒测试率差异。次要结果是男性伴侣的艾滋病毒测试率差异和两组HIV感染孕妇的PMTCT完成率。孕妇将完成一份调查员调查问卷，以收集有关HIV测试和PMTCT完成的信息。自我报告的数据将通过现场测试数据和HF确认。该提案是预防，教育，培训，治疗和研究合作伙伴（PETR-Global解决方案）/艾德斯拉里亚人（我们的尼日利亚PEPFAR资助的合作伙伴，他们将负责培训，艾滋病毒测试，与治疗的治疗和当地监督项目）； 纽约大学医学院（计划评估并与PI分享监督），董事会，NSHE，内华达州内华达大学，里诺（提供总体监督，数据管理和计划有效性评估）。