一个酒精暴露妊娠预防移动应用程序的虚拟随机对照试验,对象为城市美洲印第安人和阿拉斯加原住民年轻女性:土著 WYSE CHOICES 研究的原理、设计和方法。

A virtual randomized controlled trial of an alcohol-exposed pregnancy prevention mobile app with urban American Indian and Alaska Native young women: Native WYSE CHOICES rationale, design, and methods.

机构信息

Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado-Anschutz Medical Campus, Mail Stop F800, 13055 East 17(th) Avenue, Aurora, CO 80045, United States of America.

mHealth Impact Lab, Department of Community and Behavioral Health, Colorado School of Public Health, Mail Stop F802, 13055 East 17(th) Avenue, Aurora, CO 80045, United States of America.

出版信息

Contemp Clin Trials. 2023 May;128:107167. doi: 10.1016/j.cct.2023.107167. Epub 2023 Mar 30.

Abstract

BACKGROUND

Fetal Alcohol Spectrum Disorders (FASD) result in lifelong disability and are a leading cause of preventable birth defects in the US, including for American Indian and Alaska Natives (AIANs). Prevention of alcohol exposed pregnancies (AEPs), which can cause FASD, is typically aimed at adult women who are risky drinkers and have unprotected sex. Among AIANs, AEP prevention research has been primarily conducted in reservation communities, even though over 70% of AIANs live in urban areas. Culturally appropriate AEP prevention for urban AIAN young women, regardless of current drinking or sexual behaviors, may maximize the potential for primary prevention at the beginning of the reproductive years for this underserved population.

METHODS

We developed a virtual randomized controlled trial (RCT) - fully implemented through technology - to evaluate Native WYSE CHOICES, a culturally tailored mobile app, with urban AIAN young women ages 16-20 nationally. While virtual RCTs are not new, this is the first engaging a solely urban AIAN population, historically excluded from research. Participants are recruited on a rolling basis through the project social media community, organizational partnerships, and in-person events. Eligible participants complete a baseline survey and are randomized to either the app's intervention or comparison arm - each of which provide about 3 h of content. Follow-up data are collected at 1-, 6-, and 12-months post-baseline.

RESULTS

Our study offers a template for building trust and extending reach to this underserved population while also providing important lessons and insights on advances in virtual or hybrid research approaches.

摘要

背景

胎儿酒精谱系障碍(FASD)会导致终身残疾,是美国可预防出生缺陷的主要原因,包括美国印第安人和阿拉斯加原住民(AIANs)。预防可导致 FASD 的酒精暴露妊娠(AEPs)通常针对有风险的饮酒和无保护性行为的成年女性。在 AIAN 中,AEP 预防研究主要在保留地社区进行,尽管超过 70%的 AIAN 居住在城市地区。针对城市 AIAN 年轻女性的文化上适当的 AEP 预防措施,无论其当前的饮酒或性行为如何,都可能最大限度地提高为这一服务不足人群在生殖期开始时进行初级预防的潜力。

方法

我们开发了一个虚拟随机对照试验(RCT)-完全通过技术实现-以评估针对城市 AIAN 年轻女性(年龄在 16-20 岁之间)的本土化移动应用程序 Native WYSE CHOICES。虽然虚拟 RCT 并不新鲜,但这是第一次涉及到一个完全由城市 AIAN 组成的人群,他们在历史上被排除在研究之外。参与者通过项目社交媒体社区、组织伙伴关系和现场活动,以滚动的方式招募。符合条件的参与者完成基线调查,并随机分配到应用程序的干预组或对照组-每组提供约 3 小时的内容。随访数据在基线后 1、6 和 12 个月收集。

结果

我们的研究为与这一服务不足的人群建立信任和扩大联系提供了一个模板,同时也为虚拟或混合研究方法的进展提供了重要的经验教训和见解。

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