Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults (EMERGE)

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

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.

Study Overview

• Status: Completed
• Conditions: Feasibility
• Intervention / Treatment: Behavioral: Intervention; Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.	Behavioral: Intervention; Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.
Other: Control; Job announcements only	Behavioral: Control; Participants will receive job announcements only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Larissa Jennings Mayo-Wilson, PhD MHS, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• Jennings Mayo-Wilson L, Coleman J, Timbo F, Latkin C, Torres Brown ER, Butler AI, Conserve DF, Glass NE. 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. BMC Public Health. 2020 Dec 2;20(1):1846. doi: 10.1186/s12889-020-09904-x.
• Jennings Mayo-Wilson L, Coleman J, Timbo F, Ssewamala FM, Linnemayr S, Yi GT, Kang BA, Johnson MW, Yenokyan G, Dodge B, Glass NE. Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American Young Adults (EMERGE): A Feasibility Randomized Clinical Trial. AIDS Behav. 2020 Dec;24(12):3545-3561. doi: 10.1007/s10461-020-02931-0.
• Mayo-Wilson LJ, Glass NE, Ssewamala FM, Linnemayr S, Coleman J, Timbo F, Johnson MW, Davoust M, Labrique A, Yenokyan G, Dodge B, Latkin C. Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial. Trials. 2019 Jul 17;20(1):439. doi: 10.1186/s13063-019-3529-7.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): August 19, 2019
• Study Completion (Actual): August 19, 2019

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB00008833; K01MH107310 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data (IPD) will be shared.
• IPD Sharing Time Frame: The IPD will be posted on a permanent online data repository within 36 months after study completion.
• IPD Sharing Access Criteria: There are no access criteria.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No