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

无家可归和失业等经济脆弱性是美国少数族裔感染艾滋病毒的原因之一。然而，很少有经济强化干预措施适用于该人群的艾滋病毒预防。这项研究评估了对经济上处于弱势的非洲裔美国年轻人进行为期 20 周的微型企业干预的随机临床试验的可行性。让微型企业E参与资源生成和健康E _赋权（EMERGE）旨在减少性风险行为并增加就业和艾滋病毒预防行为的吸收。实验组收到有关职位空缺、教育课程、指导、启动资金以及商业和艾滋病毒预防的短信。对照组仅收到有关职位空缺的短信。主要可行性目标评估了招募、随机化、参与和保留。次要目标检查了就业、性危险行为和艾滋病毒预防行为。结果评估使用了干预前后的面对面访谈和每周短信调查。满足最终试验的几个进展标准。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% 被保留。比较干预增强了随机化的意愿并减少了不参与。参与者的平均年龄为 21.0 岁；35% 是男性；81% 失业。58% (58%) 的实验参与者完成了 ≥ 70% 的干预活动，74% 的参与者完成了 ≥ 50% 的干预活动。在研究的前半部分（约 10 周），参与干预活动和结果评估的人数最多。71% (71%) 的每周短信调查在第 14 周内收到了回复，但在研究结束时，有 37% 的参与者对每周短信调查的 70% 以上做出了回复。与报告的就业变化（37% 至 47%）和无保护性行为（63 % 到 53%) 在对照组中随时间变化。进行这种可行性试验是设计和测试行为干预过程中的关键步骤。开发一个完全有效的有效性试验应该考虑到在干预持续时间、筛查和测量方面的经验教训。

试验注册ClinicalTrials.gov。NCT03766165。2018 年 12 月 4 日注册。 https://clinicaltrials.gov/ct2/show/NCT03766165