(WITHDRAWN) Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices (EMERGE): A Feasibility Randomized Clinical Trial

Background: 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. In addition, text messages may improve implementation and evaluation of HIV behavioral interventions at lower cost and lower research burden. Yet, despite high rates of cell phone use and alarmingly high rates of HIV in African-American young adults, few HIV risk reduction programs have used integrated text messages to mitigate and assess sexual risk behaviors. Methods: 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. Primary feasibility objectives assessed recruitment, randomization, participation, and retention. Secondary objectives examined employment, sexual risk behaviors, and HIV preventive behaviors. We also assessed participant acceptability in using weekly text messages to conduct outcome assessment and promote healthy micro-business and HIV-preventive sexual practices. Results: Several progression criteria for a definitive trial were met. Thirty-eight (n=38) participants were randomized to experimental (n=19) or comparison group (n=19) of which 95% were retained. Mean age of participants was 20.1 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. 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. Seventy-nine percent (79%) of participants responded to > 70% of weekly text message surveys. The proportion of text message surveys that received a response was 81%, although participation declined over time. Eighty-four percent (84%) of comparison participants reported liking the job announcements, and 82% of experimental participants reported that the additional micro-business and HIV prevention text messages were very helpful. Successes included tailored messaging, anonymity, convenience, incentives, and preliminary efficacy in decreased unprotected sex (79% to 58%) and improved employment (32% to 83%). Challenges related to technical delays and intermittent non-response. Conclusions: Conducting this feasibility randomized clinical 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. Future HIV risk-reduction initiatives may also consider the potential of text message-based promotion and outcome assessment.