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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.

ABSTRACT: Background: Acceptability is a critical requisite in establishing feasibility when planning a larger effectiveness trial. This study assessed the acceptability of conducting a feasibility randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults, aged 18 to 24, in Baltimore, Maryland. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors.

Methods: Thirty-eight participants were randomized to experimental (n =?19) or comparison group (n?=?19). 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. Qualitative and quantitative post-intervention, in-person interviews were used in addition to process documentation of study methods.

Results: Our results found that the study design and interventions showed promise for being acceptable to economically-vulnerable African-American young adults. The largely positive endorsement suggested that factors contributing to acceptability included perceived economic potential, sexual health education, convenience, incentives, and encouraging, personalized feedback to participants. Barriers to acceptability for some participants included low cell phone connectivity, perceived payment delays, small cohort size, and disappointment with one's randomization assignment to comparison group. Use of peer referral, network, or wait-list designs, in addition to online options may enhance acceptability in a future definitive trial. Expanding administrative and mentoring support may improve overall experience.

Conclusion: Microenterprise interventions are acceptable ways of providing young adults with important financial and sexual health content to address HIV risks associated with economic vulnerability.

Trial registration: ClinicalTrials.gov. NCT03766165 . Registered 04 December 2018.

SUBMITTER: Jennings Mayo-Wilson L

PROVIDER: S-EPMC7709242 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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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.

Jennings Mayo-Wilson Larissa L Coleman Jessica J Timbo Fatmata F Latkin Carl C Torres Brown Elizabeth R ER Butler Anthony I AI Conserve Donaldson F DF Glass Nancy E NE

BMC public health 20201202 1

<h4>Background</h4>Acceptability is a critical requisite in establishing feasibility when planning a larger effectiveness trial. This study assessed the acceptability of conducting a feasibility randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults, aged 18 to 24, in Baltimore, Maryland. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employm ...[more]

PMID: 33267860

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Project description: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.

Project description:BackgroundEconomic 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/designIn 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT03766165 . Registered on 4 December 2018.

Project description:BackgroundSexual assault is associated with increased risk for both posttraumatic stress (PTS) and alcohol misuse. Mobile health interventions have shown promise in addressing PTS and substance use in trauma survivors and might be a promising strategy in extending the reach of early interventions to individuals who have recently experienced trauma.ObjectiveThis study assesses the feasibility and acceptability of THRIVE, a mobile health early intervention for recent survivors of sexual assault involving a cognitive behavioral app used daily over 21 days with weekly telephone coaching.MethodsTwenty adult female survivors of past-10-week sexual assault with elevated PTS and alcohol use were randomized to receive the THRIVE intervention as part of a pilot randomized controlled trial. We sought to understand feasibility by examining rates of completion of intervention activities and testing changes in participants' self-reported knowledge of key intervention concepts from baseline to after the intervention. We assessed acceptability by collecting self-report ratings of satisfaction with the intervention and app usability in a follow-up survey. The coach took notes during coaching calls to track call content and record participant feedback; these notes were qualitatively analyzed to elaborate on the aforementioned domains.ResultsFeasibility was demonstrated by moderate rates of activity completion: all participants at least opened the app, 19 (95%) of the 20 participants completed at least 1 cognitive behavioral exercise, and 16 (80%) of the 20 participants attended all 4 coaching calls. Participants completed cognitive behavioral exercises on an average of 10.40 (SD 6.52) out of 21 days. The coaching call notes documented participant comments that app-generated reminders increased completion rates. Feasibility was also demonstrated by the finding that knowledge changes occurred from baseline to after the intervention; this indicated that THRIVE was successful in conveying key concepts. Acceptability was demonstrated by high participant ratings of THRIVE's usability; the ratings corresponded to a B+ usability grade. The coaching call notes documented that usability was increased by the coaching calls, the app exercises' clarity, and the app exercises' inclusion of suggestions; however, the coaching call notes also documented that some of the participants found aspects of the app exercises to be difficult or confusing. Acceptability was also demonstrated by participant ratings of satisfaction: most of the participants (15/16, 94%) rated the app as either moderately helpful or very helpful. The coaching call notes documented that the cognitive behavioral activity modules were seen as appealing and that the positive impact of the intervention contributed to participants' satisfaction.ConclusionsThese findings suggest that THRIVE is feasible and acceptable to survivors of recent sexual assault and that further testing of THRIVE is warranted.Trial registrationClinicalTrials.gov NCT03703258; https://clinicaltrials.gov/ct2/show/NCT03703258.

Project description:Background: Many children are not engaging in sufficient physical activity and there are substantial between-children physical activity inequalities. In addition to their primary role as educators, teachers are often regarded as being well-placed to make vital contributions to inclusive visions of physical activity promotion. With the dramatic increase in popularity of wearable technologies for physical activity promotion in recent years, there is a need to better understand teachers' perspectives about using such devices, and the data they produce, to support physical activity promotion in schools. Method: Semi-structured interviews were conducted with 26 UK-based primary school teachers, exploring their responses to children's physical activity data and their views about using wearable technologies during the school day. Interview discussions were facilitated by an elicitation technique whereby participants were presented with graphs illustrating children's in-school physical activity obtained from secondary wearable technology data. Interview transcripts were thematically analyzed. Results: Most teachers spoke positively about the use of wearable technologies specifically designed for school use, highlighting potential benefits and considerations. Many teachers were able to understand and critically interpret data showing unequal physical activity patterns both within-and between-schools. Being presented with the data prompted teachers to provide explanations about observable patterns, emotional reactions-particularly about inequalities-and express motivations to change the current situations in schools. Conclusion: These findings suggest that primary school teachers in the UK are open to integrating wearable technology for measuring children's physical activity into their practices and can interpret the data produced by such devices. Visual representations of physical activity elicited strong responses and thus could be used when working with teachers as an effective trigger to inform school practices and policies seeking to address in-school physical inactivity and inequalities.

Project description:OBJECTIVE:Sexual concerns are often unaddressed for breast cancer patients; one reason is inadequate clinician training. We examined the feasibility, acceptability, and potential benefits of a novel intervention, improving Sexual Health and Augmenting Relationships through Education (iSHARE) for breast cancer clinicians. METHODS:Clinicians received training in communicating about sexual concerns with breast cancer patients. Intervention feasibility and acceptability were measured through enrollment/participation and postintervention program evaluations, respectively. Intervention effects were assessed through (1) clinician self-reported beliefs about sexual health communication, assessed at baseline, post-intervention, and 1- or 6-month follow-up, (2) clinical communication coded from audio recorded, transcribed clinic encounters at preintervention or postintervention, and (3) patient satisfaction with clinical care, reported immediately after the clinic visit. Patients also reported sociodemographic characteristics and level of sexual concerns. RESULTS:Seven breast cancer clinicians enrolled (88% participation), completed the intervention, and were audio recorded in clinic encounters with 134 breast cancer outpatients (67 each at preintervention or postintervention). Program evaluations supported intervention acceptability. Effect sizes suggest iSHARE increased clinicians' self-efficacy (d = 0.27) and outcome expectancies for communicating about sexual concerns (d = 0.69) and reduced communication barriers (d = -0.14). Clinicians' sexual health communication behaviors increased from baseline to postintervention, including for raising the topic (28% vs 48%), asking questions (33% vs 45%), and offering information (18% vs 24%). Neither patient satisfaction nor duration of sexual health communication changed (mean duration less than 1 minute at both time points). CONCLUSIONS:The iSHARE intervention was feasible and well received by clinicians and may change breast cancer clinicians' beliefs and communication behaviors regarding sexual health.

Dataset Information

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.

Publications

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.

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