Indiana University School of Public Health, Department of Applied Health Science, 1025 E. 7th Street, Bloomington, IN, USA.
Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.
AIDS Behav. 2020 Dec;24(12):3545-3561. doi: 10.1007/s10461-020-02931-0.
Economic vulnerability, such as homelessness and unemployment, contributes to HIV risk among U.S. racial minorities. Yet, few economic-strengthening interventions have been adapted for HIV prevention in this population. This study assessed the feasibility of conducting a randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors. The experimental group received text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages. The comparison group received text messages on job openings only. Primary feasibility objectives assessed recruitment, randomization, participation, and retention. Secondary objectives examined employment, sexual risk behaviors, and HIV preventive behaviors. Outcome assessments used an in-person pre- and post-intervention interview and a weekly text message survey. Several progression criteria for a definitive trial were met. Thirty-eight participants were randomized to experimental (n = 19) or comparison group (n = 19) of which 95% were retained. The comparison intervention enhanced willingness to be randomized and reduced non-participation. Mean age of participants was 21.0 years; 35% were male; 81% were unemployed. Fifty-eight percent (58%) of experimental participants completed ≥ 70% of intervention activities, and 74% completed ≥ 50% of intervention activities. Participation in intervention activities and outcome assessments was highest in the first half (~ 10 weeks) of the study. Seventy-one percent (71%) of weekly text message surveys received a response through week 14, but responsiveness declined to 37% of participants responding to ≥ 70% of weekly text message surveys at the end of the study. The experimental group reported higher employment (from 32% at baseline to 83% at week 26) and lower unprotected sex (79% to 58%) over time compared to reported changes in employment (37% to 47%) and unprotected sex (63% to 53%) over time in the comparison group. Conducting this feasibility trial was a critical step in the process of designing and testing a behavioral intervention. Development of a fully-powered effectiveness trial should take into account lessons learned regarding intervention duration, screening, and measurement.Trial Registration ClinicalTrials.gov. NCT03766165. Registered 04 December 2018. https://clinicaltrials.gov/ct2/show/NCT03766165.
经济脆弱性，如无家可归和失业，导致美国少数族裔的艾滋病毒风险增加。然而，针对这一人群的艾滋病毒预防措施，很少有经济加强干预措施。本研究评估了为经济脆弱的非裔美国年轻成年人进行为期 20 周微型企业干预的随机临床试验的可行性。创业促进资源生成和健康赋权（EMERGE）旨在减少性风险行为，增加就业和采取艾滋病毒预防行为。实验组收到有关工作机会的短信，外加教育课程、指导、启动赠款以及有关业务和艾滋病毒预防的短信。对照组仅收到有关工作机会的短信。主要可行性目标评估了招募、随机化、参与和保留情况。次要目标研究了就业、性风险行为和艾滋病毒预防行为。结果评估采用面对面的预干预和后干预访谈以及每周短信调查。确定试验的几个进展标准得到了满足。38 名参与者被随机分配到实验组（n=19）或对照组（n=19），其中 95%得到保留。比较干预措施提高了对随机分组的意愿并减少了不参与。参与者的平均年龄为 21.0 岁；35%为男性；81%失业。实验组 58%（58%）完成了≥70%的干预活动，74%完成了≥50%的干预活动。在研究的前半段（约 10 周），参与干预活动和结果评估的人数最多。在第 14 周之前，每周短信调查的 71%（71%）收到回复，但在研究结束时，只有 37%的参与者回复了每周短信调查的≥70%。实验组报告说，就业（从基线时的 32%增加到第 26 周时的 83%）和无保护性行为（从 79%下降到 58%）随时间变化的比例高于对照组（就业从 37%增加到 47%，无保护性行为从 63%增加到 53%）。进行这项可行性试验是设计和测试行为干预措施的关键步骤。完全有效的试验应考虑到干预持续时间、筛选和测量方面的经验教训。试验注册临床Trials.gov。NCT03766165。2018 年 12 月 4 日注册。https://clinicaltrials.gov/ct2/show/NCT03766165。
