FAS Prevention: A Trial of the IOM Model

产品说明：世界上胎儿酒精综合征（FAS）发病率最高的地方是南非（SA），这个城镇是预防研究的目标。在第一波和第二波研究中，FAS的发生率分别为46/1000和75/1000，第三波的初步发生率为79/1000。在南非的其他地区，FAS的患病率很高。预防研究对南非、美国和发展中国家的项目有着广泛的影响。这是一项由医学研究所（IOM）定义的综合性、公共卫生模式、社区范围内FAS预防计划的多中心、疗效试验。它利用比较社区和预防前/后设计，通过对儿童和婴儿FAS的严格诊断进行评估，并通过随机抽样饮酒习惯调查的措施反映饮酒习惯的变化。严格的方案评估还将评估土著工人采用的具体指示、选定和普遍的预防技术。多层次的干预措施包括：所指出的预防措施，通过以下方式降低孕产妇风险：对高危人群进行个案管理、获得节育服务和加强营养;利用动机访谈和社区强化方法的原则进行简短干预;以及个人赋权/技能建设。选择性和普遍的预防用途：筛查酗酒;有针对性的信息以改变规范和KABB;政策倡导;以及社区教育和对话。 目前的试验已经修改为开始，以解决艾滋病毒/艾滋病的共病状况，这是目前在相同的高危妇女，并有许多相同的病因学因素预测不良妊娠结局。由于这项预防试验是设计为全面和社区范围内，有多种机会进行数据收集，风险评估，并评价孕产妇和胎儿干预措施对FASD和HIV/AIDS高危母亲及其子女的有效性。 预防网站（城市和农村的组成部分）与四个比较社区，将进行分析，并作为不同的实体，以评估混杂的影响。利用IOM推荐的研究和预防技术，以前在美国印第安人社区中应用，本研究将确定SA中FAS的社区范围预防的功效，以及哪些具体成分最可行。预防设计中的嵌套研究还涉及基础研究，以进一步明确FAS的流行病学和临床特征、成人饮酒和FAS的母体风险因素。具体目标是：（1）评估IOM、FAS预防计划的有效性; 2.）通过特定年龄FAS率的变化直接测量流行病学“仅研究”阶段的预防功效; 3.）衡量成人知识、态度、信仰和饮酒行为（KABB）的变化以及社区对变化的准备; 4.）通过进程评价将预防活动的参与程度与具体成果联系起来; 5.）进一步定义FAS的母体风险因素;以及6.）通过巢式研究探索风险和保护的基本问题;和7）检查南非西开普省艾滋病毒/艾滋病的流行率和特征以及风险因素，包括疾病进展、艾滋病药物可用性和艾滋病毒相关的胎儿结局。

DESCRIPTION: The highest rates of fetal alcohol syndrome (FAS) in the world have been found in South Africa (SA) in this town targeted for prevention research. Rates of FAS were 46 and 75 per 1,000 in waves I and II of research and a preliminary rate in Wave III is 79. A high prevalence of FAS exists in other parts of SA. Prevention research has broad implications for programs in SA, the US, and developing populations. This is a multi-site, efficacy trial of a comprehensive, public health model, community-wide, FAS prevention program defined by the Institute of Medicine (IOM). It utilizes both comparative community and pre/post prevention designs with assessment via rigorous diagnosis of FAS in children and infants and also change in drinking practices reflected in measures from a random sample drinking practices survey. Rigorous program evaluation will also assess specific indicated, selected, and universal prevention techniques applied by indigenous workers. Multilevel interventions include: indicated prevention where maternal risk is reduced via: case management of high risk individuals, access to birth control, and enhanced nutrition; brief interventions using principles of motivational interviewing and community reinforcement approach; and individual empowerment/skills building. Selective and universal prevention use: screening for alcohol abuse; targeted messages to change norms and KABB; policy advocacy; and community education and dialogue. The current trial has been modified to begin to address the comorbid condition of HIV/AIDS that is present in the same high-risk women and has many of the same etiological factors predicting adverse pregnancy outcomes. Because this prevention trial is designed as comprehensive and community-wide, there are multiple opportunities for data collection, risk assessment, and evaluation of efficacy of maternal and fetal interventions on both FASD and HIV/AIDS at-risk mothers and their children. The prevention site (urban and rural components) is matched with four comparison communities which will be analyzed in aggregate and as distinct entities to assess confounding influences. Utilizing lOM-recommended techniques of research and prevention applied previously in American Indian communities, this study will determine the efficacy of community-wide prevention of FAS in SA, and which specific components are most viable. Nested studies within the prevention design also address basic research for further specificity of epidemiologic and clinical characteristics of: FAS, adult drinking, and maternal risk factors for FAS. Specific aims are to: 1.) assess the efficacy of the IOM, FAS prevention program; 2.) directly measure the prevention efficacy of the epidemiology "research only" phase via change in age-specific FAS rates; 3.) measure change in adult knowledge, attitudes, beliefs, and drinking behavior (KABB) as well as community readiness for change; 4.) link the level of participation in prevention activities to specific outcomes through process evaluation; 5.) further define maternal risk factors for FAS; and 6.) explore basic issues of risk and protection via nested studies; and 7) examine the prevalence and characteristics of, and risk factors for HIV/AIDS in the Western Cape Province of South Africa including disease progression, AIDS medication availability, and HIV-related fetal outcomes.