Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults

NCT03766165 | Completed Results

• 2 other identifiers: IRB00008833K01MH107310
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Feasibility

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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 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 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 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 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

Study Arms (2)

Intervention

EXPERIMENTAL

Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.

Behavioral: Intervention

Control

OTHER

Job announcements only

Behavioral: Control

Interventions

Intervention BEHAVIORAL

Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.

Intervention

Control BEHAVIORAL

Participants will receive job announcements only.

Control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Aged 17 or younger;
• Older than 24 years;
• Unwilling to provide consent for study participation

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• 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.

  PMID: 33267860 DERIVED

• 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.

  PMID: 32494942 DERIVED

• 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.

  PMID: 31315685 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

All measures were self-reported and may be subject to reporting biases.

Results Point of Contact

• Title: Dr. Larissa Jennings Mayo-Wilson
• Organization: Johns Hopkins University; Indiana University

ljmayowi@iu.edu

1-812-856-0902

Study Officials

• Larissa Jennings Mayo-Wilson, PhD MHS

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 6, 2018
• Study Start: December 5, 2018
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The IPD will be posted on a permanent online data repository within 36 months after study completion.
• Access Criteria: There are no access criteria.

Locations

US (1)