Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults

NCT ID: NCT03766165

Last Updated: 2020-10-22

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2019-08-19

Brief Summary

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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

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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.

Conditions

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Feasibility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

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

Control

Job announcements only

Group Type OTHER

Control

Intervention Type BEHAVIORAL

Participants will receive job announcements only.

Interventions

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Intervention

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

Intervention Type BEHAVIORAL

Control

Participants will receive job announcements only.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* Aged 17 or younger;
* Older than 24 years;
* Unwilling to provide consent for study participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Larissa Jennings Mayo-Wilson, PhD MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33267860 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32494942 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31315685 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K01MH107310

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00008833

Identifier Type: -

Identifier Source: org_study_id

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