Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults

Feasibility Clinical Trial

— EMERGE  

Official title:

The Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project: Feasibility Trial of an Enhanced Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766165
• Other study ID #: IRB00008833
• Secondary ID: K01MH107310
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: August 19, 2019

Study information

• Verified date: September 2020
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion criteria are:

• African American;

• Aged 18-24;

• Living in Baltimore City;

• Having experienced one episode of homelessness in last 12 months;

• Unemployed or employed fewer than 10 hours per week;

• Not enrolled in school;

• Owning a mobile phone with text messaging function;

• Reporting at least one episode of unprotected/unsafe sex in prior 12 months

Exclusion criteria are:

• Aged 17 or younger;

• Older than 24 years;

• Unwilling to provide consent for study participation

Related Conditions & MeSH terms

• Feasibility

Intervention

Behavioral:
• Intervention
Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.
• Control
Participants will receive job announcements only.

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys	Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)	Measured at week 26
Primary	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)	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)	Measured at week 23
Secondary	Proportion of All Participants Who Receive One or More Informational Text Messages	Proportion of all participants who receive one or more informational text messages (description)	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
Secondary	Proportion of All Participants Who Respond to the Text Message Survey	Proportion of all participants who respond to the text message survey (description)	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
Secondary	Proportion of Intervention Participants Who Attend an Educational Session	Proportion of intervention participants who attend an educational session (description)	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
Secondary	Proportion of Intervention Participants Who Receive One or More Mentor Contacts	Proportion of intervention participants who receive one or more mentor contacts (description)	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
Secondary	Proportion of Intervention Participants Who Spend One or More Grant Payments	Proportion of intervention participants who spend one or more grant payments (description)	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
Secondary	Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week	Proportion of participants in each group who report one or more unprotected sex acts in last week (description)	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
Secondary	Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month	Proportion of participants in each group who report one or more unprotected sex acts in last month (description)	Measured at week 1 and 26
Secondary	Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week	Proportion of participants in each group who report one or more safer sex acts in last week (description)	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
Secondary	Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month	Proportion of participants in each group who report one or more safer sex acts in last month (description)	Measured at week 1 and 26
Secondary	Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week	Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last week (description)	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
Secondary	Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month	Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last month (description)	Measured at week 1 and 26
Secondary	Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week	Proportion of participants in each group who report one or more paid hours of work in the last week (description)	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
Secondary	Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month	Proportion of participants in each group who report one or more paid hours of work in the last month (description)	Measured weekly at week 1 and 26