Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial

Abstract

Background 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT03766165 . Registered on 4 December 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3529-7) contains supplementary material, which is available to authorized users.

Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American Young Adults (EMERGE): A Feasibility Randomized Clinical Trial

“…Details of the study’s participant recruitment process have been published previously in a protocol manuscript [ 34 ]. Study eligibility was determined using a screening tool during an in-person enrollment process.…”

“…Figure 2 highlights components of the experimental intervention. Additional details regarding both interventions, including rationale, structure, and processes are published in the aforementioned protocol manuscript [ 34 ].

Fig.

…”

Acceptability of a feasibility randomized clinical trial of a microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices (EMERGE) in young adults: a mixed methods assessment

“…Interventions Figure 2 depicts core intervention activities. Specific information regarding the interventions and text message assessments are published in the aforementioned protocol manuscript [37]. In summary, the experimental intervention participants were provided: (1) a weekly text message each on local job announcements every Monday; (2) a weekly two-hour educational classroom-based session relating to HIV prevention and microbusiness start-up on Wednesdays; (3) an assigned mentor according to each participant's microbusiness interests; 4) a microgrant of $1100.00 USD; and (5) three weekly text messages relating to microenterprise and HIV prevention.…”

“…The overall aim of the feasibility trial was to assess five domains: participant recruitment, randomization, participation, retention, and acceptability. Progression criteria based on findings across all domains were developed to determine whether and how to proceed to a full-scale trial, such as the ability to reach the target sample, achieving ≥70% study participation, minimizing loss-to-follow-up, and having sufficient acceptability [37]. A previously published main outcomes manuscript reports on quantitative progression criteria from the researcher's perspective as it related to recruitment, randomization, retention, and participation, in addition to changes in sexual and economic outcomes [38].…”

Personal and Lifestyle Determinants of HIV Transmission Risk in Spanish University Students

“…When the other personal characteristics of individuals have been taking into account, contextual variables, such as socioeconomic or employment status, emerge as significant influential variables for the development of HIV risk behaviors [ 14 , 15 ]. In particular, economic vulnerability (i.e., low income and unemployment) has been associated with an increased risk of HIV transmission.…”