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Table 4 Process documentation findings of intervention successes, challenges, and potential modifications of EMERGE feasibility randomized clinical trial

From: 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

  Successes Challenges Potential modifications for effectiveness trial
Recruitment On-site information and screening enhanced identification of participants. Initial high motivation met by low engagement by some participants. Assess readiness to start a business, such as referral or extended screening.
Randomization Most participants completed steps for randomization eligibility. Some participants were disappointed with randomization assignment. Consider cluster randomization or wait-list control design.
Intervention participation
 Sessions Sessions held at CBO at two different times with lunch and make-up materials. Attendance declined over time with some training goals being too advanced. More frequent, simplified sessions over shorter study period with travel supplement.
 Grants Prepared milestones and approved spending plan prior to disbursement. Some funds were unspent due to low financial literacy in ordering supplies. Provide more support for purchasing supplies and materials via accountant.
 Mentors Local and racially-diverse entrepreneurs matched to participants’ interests. Schedules conflicted with sessions with limited ability to hire some participants, low trust. Engage mentors at participant enrollment, using trust-building activities.
Non-participation Minimized non-participation during first half of study (weeks 1 to 10). Changing schedules or phone availability interrupted session attendance and survey completion, respectively. Provide option to participate in asynchronous, online educational sessions and email/phone surveys.
Text message survey Convenient and easy to use with weekly payment for response. Malfunctioning phone and/or service at times with payment delays. Include fewer questions over shorter study period with mobile payment.
Sample size Appropriate for feasibility assessment and enabled personal attention. Some participants wanted larger cohort to maximize peer interaction and group businesses. Consider peer referral at study enrollment for larger effectiveness trial cohort.