scholarly journals 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

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Larissa Jennings Mayo-Wilson ◽  
Jessica Coleman ◽  
Fatmata Timbo ◽  
Carl Latkin ◽  
Elizabeth R. Torres Brown ◽  
...  

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.

2020 ◽  
Vol 24 (12) ◽  
pp. 3545-3561 ◽  
Author(s):  
Larissa Jennings Mayo-Wilson ◽  
Jessica Coleman ◽  
Fatmata Timbo ◽  
Fred M. Ssewamala ◽  
Sebastian Linnemayr ◽  
...  

AbstractEconomic 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


10.2196/14833 ◽  
2020 ◽  
Vol 4 (7) ◽  
pp. e14833
Author(s):  
Larissa Jennings Mayo-Wilson ◽  
Nancy E Glass ◽  
Alain Labrique ◽  
Melissa Davoust ◽  
Fred M Ssewamala ◽  
...  

Background Text messages offer the potential to better evaluate HIV behavioral interventions using repeated longitudinal measures at a lower cost and research burden. However, they have been underused in US minority settings. Objective This study aims to examine the feasibility of assessing economic and sexual risk behaviors using text message surveys. Methods We conducted a single-group study with 17 African-American young adults, aged 18-24 years, who were economically disadvantaged and reported prior unprotected sex. Participants received a text message survey once each week for 5 weeks. The survey contained 14 questions with yes-no and numeric responses on sexual risk behaviors (ie, condomless sex, sex while high or drunk, and sex exchange) and economic behaviors (ie, income, employment, and money spent on HIV services or products). Feasibility measures were the number of participants who responded to the survey in a given week, the number of questions to which a participant responded in each survey, and the number of hours spent from sending a survey to participants to receiving their response in a given week. One discussion group was used to obtain feedback. Results Overall, 65% (n=11/17) of the participants responded to at least one text message survey compared with 35% (n=6/17) of the participants who did not respond. The majority (n=7/11, 64%) of the responders were women. The majority (n=4/6, 67%) of nonresponders were men. An average of 7.6 participants (69%) responded in a given week. Response rates among ever responders ranged from 64% to 82% across the study period. The mean number of questions answered each week was 12.6 (SD 2.7; 90% of all questions), ranging from 72% to 100%. An average of 6.4 participants (84%) answered all 14 text message questions in a given week, ranging from 57% to 100%. Participants responded approximately 8.7 hours (SD 10.3) after receiving the survey. Participants were more likely to answer questions related to employment, condomless sex, and discussions with sex partners. Nonresponse or skip was more often used for questions at the end of the survey relating to sex exchange and money spent on HIV prevention services or products. Strengths of the text message survey were convenience, readability, short completion time, having repeated measures over time, and having incentives. Conclusions Longitudinal text message surveys may be a valuable tool for assessing HIV-related economic and sexual risk behaviors. Trial Registration ClinicalTrials.gov NCT03237871; https://clinicaltrials.gov/ct2/show/NCT03237871


Author(s):  
Larissa Jennings Mayo-Wilson ◽  
Nancy E Glass ◽  
Alain Labrique ◽  
Melissa Davoust ◽  
Fred M Ssewamala ◽  
...  

BACKGROUND Text messages offer the potential to better evaluate HIV behavioral interventions using repeated longitudinal measures at a lower cost and research burden. However, they have been underused in US minority settings. OBJECTIVE This study aims to examine the feasibility of assessing economic and sexual risk behaviors using text message surveys. METHODS We conducted a single-group study with 17 African-American young adults, aged 18-24 years, who were economically disadvantaged and reported prior unprotected sex. Participants received a text message survey once each week for 5 weeks. The survey contained 14 questions with yes-no and numeric responses on sexual risk behaviors (ie, condomless sex, sex while high or drunk, and sex exchange) and economic behaviors (ie, income, employment, and money spent on HIV services or products). Feasibility measures were the number of participants who responded to the survey in a given week, the number of questions to which a participant responded in each survey, and the number of hours spent from sending a survey to participants to receiving their response in a given week. One discussion group was used to obtain feedback. RESULTS Overall, 65% (n=11/17) of the participants responded to at least one text message survey compared with 35% (n=6/17) of the participants who did not respond. The majority (n=7/11, 64%) of the responders were women. The majority (n=4/6, 67%) of nonresponders were men. An average of 7.6 participants (69%) responded in a given week. Response rates among ever responders ranged from 64% to 82% across the study period. The mean number of questions answered each week was 12.6 (SD 2.7; 90% of all questions), ranging from 72% to 100%. An average of 6.4 participants (84%) answered all 14 text message questions in a given week, ranging from 57% to 100%. Participants responded approximately 8.7 hours (SD 10.3) after receiving the survey. Participants were more likely to answer questions related to employment, condomless sex, and discussions with sex partners. Nonresponse or <i>skip</i> was more often used for questions at the end of the survey relating to sex exchange and money spent on HIV prevention services or products. Strengths of the text message survey were convenience, readability, short completion time, having repeated measures over time, and having incentives. CONCLUSIONS Longitudinal text message surveys may be a valuable tool for assessing HIV-related economic and sexual risk behaviors. CLINICALTRIAL ClinicalTrials.gov NCT03237871; https://clinicaltrials.gov/ct2/show/NCT03237871


2009 ◽  
Vol 77 (4) ◽  
pp. 657-667 ◽  
Author(s):  
Mary M. Velasquez ◽  
Kirk von Sternberg ◽  
David H. Johnson ◽  
Charles Green ◽  
Joseph P. Carbonari ◽  
...  

2001 ◽  
Vol 139 (3) ◽  
pp. 407-412 ◽  
Author(s):  
Ralph J. DiClemente ◽  
Gina M. Wingood ◽  
Richard Crosby ◽  
Brenda K. Cobb ◽  
Kathy Harrington ◽  
...  

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