Randomized Trial of an Intervention for Preventing Alcohol Exposed Pregnancy among Women in a Remote Reservation Community

摘要研究项目1 在美国印第安人和阿拉斯加州，胎儿酒精谱系障碍（FASD）的患病率高达10倍 原住民（AI/AN）比一般美国人口，但FASD是100%可预防的。即使是适度饮酒 在怀孕期间可能会影响胎儿的生长和行为结果。酒精使用障碍和酗酒 女性是其后代患FASD的最大风险因素之一。AI/AN的患病率最高， 美国种族和族裔群体中的酒精使用障碍，最有可能从事酗酒 孕期越来越多的共识表明，必须开始预防酒精暴露妊娠 在怀孕之前。一个有希望的方法是改变高危酒精使用和增加避孕 有效性研究（选择），它结合了动机访谈与避孕咨询， 非妊娠女性。在一项随机试验中，接受选择的女性有36%的可能性减少， 与接受常规护理的妇女相比，6个月后酒精暴露妊娠的风险增加，但该试验未招募 AI/AN或农村妇女。尽管疾病控制和预防中心建议其 然而，在AI/AN中，CHOICES的公共卫生价值和成本效益尚不清楚。我们提出了一个 适应性干预的随机对照试验- Native-CHOICES -以降低酒精暴露的风险 在AI/AN中怀孕。我们将招募350名居住在夏延河苏族印第安人保留地的AI/AN妇女 在南达科他州，年龄在18-44岁之间，具有普遍酒精使用障碍或其他危险饮酒行为， 目前未怀孕，性活跃但未采取有效避孕措施。Native-Choices将 包括2个动机访谈会议加上1个避孕咨询会议，为期4周， 3个月的支持性电子信息，以增加感知的社会联系和支持， 改变饮酒行为和采取避孕措施。它使用等待列表控件设计，其中参与者将 随机接受常规护理加Native-CHOICES（干预）或仅接受常规护理（对照）。我们 具体目的是：1）测试Native-CHOICES与常规护理相比减少酒精暴露的有效性 6个月以上的怀孕风险（风险较低的饮酒，有效的避孕措施，或两者兼而有之）; 2）使用调查和访谈 评估本土选择的覆盖范围、可接受性和可持续性; 3）进行成本效益和成本- 对Native-CHOICES与常规护理进行全面经济评价的有效性分析。FASD 治疗费用昂贵，预防对于减少这一悲剧性和可避免的公共卫生问题至关重要。我们 这将是第一项预防AI/AN中酒精暴露怀孕的随机对照试验，也是第一项试验 农村妇女的选择，任何种族。在农村AI/AN中进行测试很重要，因为这一人群面临着 获得医疗保健的独特障碍，并且可能对酒精使用有不同的规范性观点， 与之前测试过选择的其他社区相比，

ABSTRACT RESEARCH PROJECT 1 Fetal alcohol spectrum disorder (FASD) prevalence is up to 10 times higher in American Indians and Alaska Natives (AI/ANs) than in the general US population, yet FASD is 100% preventable. Even moderate alcohol use during pregnancy can affect fetal growth and behavioral outcomes. Alcohol use disorders and binge drinking in women are among the strongest risk factors for FASD in their offspring. AI/ANs have the highest prevalence of alcohol use disorders among US racial and ethnic groups, and are the most likely to engage in binge drinking during pregnancy. A growing consensus indicates that prevention of alcohol-exposed pregnancy must begin before conception. One promising approach is the Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study (CHOICES), which combines motivational interviewing with contraception counseling for non-pregnant women. In a randomized trial, women receiving CHOICES were 36% more likely to have reduced risk for alcohol-exposed pregnancies after 6 months than women receiving usual care, but the trial did not enroll AI/ANs or rural women. Although the Centers for Disease Control and Prevention has recommended its dissemination, the public health value and cost-effectiveness of CHOICES in AI/ANs is unknown. We propose a randomized controlled trial of an adapted intervention – Native-CHOICES – to reduce risk of alcohol exposed pregnancies in AI/ANs. We will enroll 350 AI/AN women living on the Cheyenne River Sioux Indian Reservation in South Dakota who are 18-44 years old, have prevalent alcohol use disorders or other risky drinking behaviors, are not currently pregnant, and are sexually active but not using effective contraception. Native-CHOICES will consist of 2 motivational interviewing sessions plus 1 contraceptive counseling session over 4 weeks, with supportive electronic messaging for 3 months to increase perceived social connectedness and support for modifying drinking behavior and using contraception. It uses a wait-list control design in which participants will be randomized to receive either usual care plus Native-CHOICES (intervention) or usual care only (control). Our Specific Aims are to: 1) Test the effectiveness of Native-CHOICES vs. usual care for reducing alcohol-exposed pregnancy risk (less risky drinking, effective contraception, or both) over 6 months; 2) Use surveys and interviews to evaluate Native-CHOICES’ reach, acceptability, and sustainability; and 3) Conduct cost-benefit and cost- effectiveness analyses for a comprehensive economic evaluation of Native-CHOICES vs. usual care. FASD treatment is expensive and prevention is critical to reducing this tragic and avoidable public health problem. Ours will be the first randomized controlled trial to prevent alcohol-exposed pregnancies in AI/ANs, and the first trial of CHOICES for rural women of any race. Testing in rural AI/ANs is important because this population faces unique barriers to accessing healthcare, and may have different normative views on alcohol use during pregnancy compared to other communities in which CHOICES has previously been tested.