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Completed

NCT Number: NCT03766165

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.

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Key information

Conditions

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

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

Control

Behavioral

Participants will receive job announcements only.

Primary outcomes

  1. Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys

    Time frame: Measured at week 26

    Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)

  2. 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)

    Time frame: 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 outcomes

  1. Proportion of All Participants Who Receive One or More Informational Text Messages

    Time frame: 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)

  2. Proportion of All Participants Who Respond to the Text Message Survey

    Time frame: 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)

  3. Proportion of Intervention Participants Who Attend an Educational Session

    Time frame: 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)

  4. Proportion of Intervention Participants Who Receive One or More Mentor Contacts

    Time frame: 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)

  5. Proportion of Intervention Participants Who Spend One or More Grant Payments

    Time frame: 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)

  6. Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week

    Time frame: 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)

  7. Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month

    Time frame: Measured at week 1 and 26

    Proportion of participants in each group who report one or more unprotected sex acts in last month (description)

  8. Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week

    Time frame: 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)

  9. Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month

    Time frame: Measured at week 1 and 26

    Proportion of participants in each group who report one or more safer sex acts in last month (description)

  10. Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week

    Time frame: 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)

  11. Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month

    Time frame: 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)

  12. Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week

    Time frame: 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)

  13. Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study 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

Acronym: EMERGE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2018
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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