Department of International Health, Social and Behavioral Interventions Program, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E5038, Baltimore, MD, 21205, USA.
Department of Applied Health Science, Indiana University School of Public Health, 1025 E. 7th Street, Bloomington, IN, USA.
Trials. 2019 Jul 17;20(1):439. doi: 10.1186/s13063-019-3529-7.
Economic vulnerability, such as homelessness and unemployment, contributes to the HIV risk among racial minorities in the U.S., who are disproportionately infected. Yet, few economic-strengthening interventions have been adapted for HIV prevention in economically-vulnerable African-American young adults. Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) is a feasibility randomized clinical trial of an HIV prevention microenterprise intervention with integrated text messages ("nudges") that are informed by behavioral economic principles. The trial aims to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors.
METHODS/DESIGN: In total, 40 young adults who are African-American, aged 18-24, live in Baltimore City, have experienced at least one episode of homelessness in the last 12 months, are unemployed or underemployed (fewer than 10 h per week), are not enrolled in school, own a cell phone with text messaging, and report at least one episode of unprotected or unsafe sex in the prior 12 months will be recruited from two community-based organizations providing residential supportive services to urban youth. Participants will undergo a 3-week run-in period and thereafter be randomly assigned to one of two groups with active interventions for 20 weeks. The first group ("comparison") will receive text messages with information on job openings. The second group ("experimental") will receive text messages with information on job openings plus information on HIV prevention and business educational sessions, a mentored apprenticeship, and a start-up grant, and business and HIV prevention text messages based on principles from behavioral economics. The two primary outcomes relate to the feasibility of conducting a larger trial. Secondary outcomes relate to employment, sexual risk behaviors, and HIV preventive practices. All participants will be assessed using an in-person questionnaire at pre-intervention (prior to randomization) and at 3 weeks post-intervention. To obtain repeated, longitudinal measures, participants will be assessed weekly using text message surveys from pre-intervention up to 3 weeks post-intervention.
This study will be one of the first U.S.-based feasibility randomized clinical trials of an HIV prevention microenterprise intervention for economically-vulnerable African-American young adults. The findings will inform whether and how to conduct a larger efficacy trial for HIV risk reduction in this population.
ClinicalTrials.gov, NCT03766165 . Registered on 4 December 2018.
在美国，经济脆弱性（如无家可归和失业）导致少数族裔感染艾滋病毒的风险增加，而这些少数族裔感染的比例过高。然而，针对经济脆弱的非裔美国青年，几乎没有经济增强干预措施被用于艾滋病毒预防。创业促进资源生成和健康赋权（Emerge）是一项经济脆弱的非裔美国青年艾滋病毒预防创业干预措施的可行性随机临床试验，该试验结合了基于行为经济学原理的短信“提示”。该试验旨在减少性风险行为，增加就业机会和采取艾滋病毒预防行为。
方法/设计：共有 40 名年龄在 18-24 岁之间的非裔美国青年参与了该研究，他们居住在巴尔的摩市，在过去 12 个月内至少经历过一次无家可归，失业或就业不足（每周少于 10 小时），未入学，拥有可发送短信的手机，并报告在过去 12 个月内至少有一次未使用或不安全的性行为。参与者将从两个为城市青年提供住宿支持服务的社区组织中招募。参与者将经历一个为期 3 周的预试验期，此后随机分为两组，分别接受 20 周的积极干预。第一组（“对照组”）将收到有关工作机会的短信。第二组（“实验组”）将收到有关工作机会的短信，以及有关艾滋病毒预防和商业教育课程、导师制学徒和创业赠款的信息，以及基于行为经济学原理的商业和艾滋病毒预防短信。两个主要结果与进行更大规模试验的可行性有关。次要结果与就业、性风险行为和艾滋病毒预防措施有关。所有参与者将在干预前（随机分组前）和干预后 3 周进行面对面问卷调查。为了获得重复的纵向测量，参与者将从预试验开始到干预后 3 周每周通过短信调查进行评估。
这将是美国首次针对经济脆弱的非裔美国青年开展的艾滋病毒预防创业干预措施的可行性随机临床试验之一。研究结果将为在该人群中开展更大规模的艾滋病毒风险降低疗效试验提供依据。
ClinicalTrials.gov，NCT03766165。于 2018 年 12 月 4 日注册。
