Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults

Not Applicable

Completed

Conditions: Feasibility

Interventions: Behavioral: Intervention
Behavioral: Control

Registration Number: NCT03766165

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary: The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll approximately 40 young adults. Participants will be randomly assigned to one of two groups. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up grant (provided in 6 payments), and HIV behavioral economics text messages.

Detailed Description: The study team will conduct a two-group study to examine the feasibility of implementing an enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll approximately 40 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, unemployed or under-employed, report unprotected/unsafe sex, and have access to a cell phone. Participants will be randomly assigned to one of two groups. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up grant (provided in 6 payments), and HIV behavioral economics text messages. Data will be collected for 26 weeks (week 1 to week 26). Participants will undergo a baseline in-person interview at the time of enrollment (week 1) and be randomized to a group after completing a 3-week run-in period (week 1 to week 3). Each group will receive the assigned activities for 20 weeks (week 4 to week 23). An endline in-person interview will be conducted in and around week 26, respectively. Participants will also complete a weekly text message survey from enrollment (week 1) to the end of the study (week 26). The study team will collect feasibility information pertaining to two primary outcomes: (i) the proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys at week 26 and (ii) the proportion of participants in the intervention group who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) at week 23. As secondary outcomes, the study team will collect feasibility information about the proportion of all participants who receive one or more informational text messages each week, the proportion of all participants who respond to a text message survey each week, the proportion of intervention participants who attend an educational session each week, the proportion of intervention participants who receive one or more mentor contacts each week, and the proportion of intervention participants who spend one or more grant payments each week. The study team will also examine the completion and variation in behavioral outcomes pertaining to the proportion of participants in each group who report one or more unprotected/unsafe sex acts in the last week and last month, the proportion of participants in each group who report one or more safer sex acts in the last week and last month, the proportion of participants in each group who report one or more HIV prevention care-seeking or information-seeking acts in the last week and last month, and the proportion of participants in each group who report one or more paid hours of work in the last week and last month. The study is anticipated to start in December 2018.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.
Control	Control	Job announcements only

Primary Outcome Measures

Name	Time	Method
Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys	Measured at week 26	Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)
Proportion of Intervention Participants Who Have Completed 70% or More of Intervention Activities (i.e., Text Message Receipt, Session Attendance, Grant Spending, and Mentor Contact)	Measured at week 23	Proportion of intervention participants who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) (description)

Secondary Outcome Measures

Name	Time	Method
Proportion of Intervention Participants Who Attend an Educational Session	Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23	Proportion of intervention participants who attend an educational session (description)
Proportion of Intervention Participants Who Receive One or More Mentor Contacts	Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23	Proportion of intervention participants who receive one or more mentor contacts (description)
Proportion of All Participants Who Receive One or More Informational Text Messages	Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23	Proportion of all participants who receive one or more informational text messages (description)
Proportion of All Participants Who Respond to the Text Message Survey	Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26	Proportion of all participants who respond to the text message survey (description)
Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week	Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26	Proportion of participants in each group who report one or more safer sex acts in last week (description)
Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month	Measured at week 1 and 26	Proportion of participants in each group who report one or more safer sex acts in last month (description)
Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week	Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26	Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last week (description)
Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month	Measured at week 1 and 26	Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last month (description)
Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week	Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26	Proportion of participants in each group who report one or more paid hours of work in the last week (description)
Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month	Measured weekly at week 1 and 26	Proportion of participants in each group who report one or more paid hours of work in the last month (description)
Proportion of Intervention Participants Who Spend One or More Grant Payments	Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23	Proportion of intervention participants who spend one or more grant payments (description)
Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week	Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26	Proportion of participants in each group who report one or more unprotected sex acts in last week (description)
Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month	Measured at week 1 and 26	Proportion of participants in each group who report one or more unprotected sex acts in last month (description)