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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH107310 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant. |
|
| Control | Other | Job announcements only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant. |
|
| 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 |
| 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 |
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Inclusion criteria are:
Exclusion criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Larissa Jennings Mayo-Wilson, PhD MHS | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33267860 | Derived | 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. | |
| 32494942 | 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. |
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De-identified individual patient data (IPD) will be shared.
The IPD will be posted on a permanent online data repository within 36 months after study completion.
There are no access criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant. Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant. |
| FG001 | Control | Job announcements only Control: Participants will receive job announcements only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant. Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Participants in both groups | Posted | Count of Participants | Participants | Measured at week 26 |
|
20 weeks
The study used a structured weekly participant checklist to document whether each participant experienced an intervention-related adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant. Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant. |
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All measures were self-reported and may be subject to reporting biases.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Larissa Jennings Mayo-Wilson | Johns Hopkins University; Indiana University | 1-812-856-0902 | ljmayowi@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2019 | Sep 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Control | Behavioral | Participants will receive job announcements only. |
|
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 |
| 31315685 | 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. |
| Control |
Job announcements only Control: Participants will receive job announcements only. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| One or more episodes of homelessness within last 12 months | Count of Participants | Participants |
|
Job announcements only
Control: Participants will receive job announcements only.
|
|
| 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) | Intervention participants | Posted | Count of Participants | Participants | 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) | All participants | Posted | Count of Participants | Participants | 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) | All participants including those in intervention arm and control arm | Posted | Count of Participants | Participants | 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) | Intervention Participants Allowed on Site by CBO | Posted | Count of Participants | Participants | 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) | Intervention Participants | Posted | Count of Participants | Participants | 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) | Intervention participants | Posted | Count of Participants | Participants | 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) | Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data. | Posted | 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) | Participants in each group | Posted | Count of Participants | Participants | 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) | Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data. | Posted | 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) | Participants in each group | Posted | Count of Participants | Participants | 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) | Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data. | Posted | 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) | Participants in each group | Posted | Count of Participants | Participants | 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) | Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data. | Posted | 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) | Participants in each group | Posted | Count of Participants | Participants | Measured weekly at week 1 and 26 |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Control | Job announcements only Control: Participants will receive job announcements only. | 0 | 19 | 0 | 19 | 0 | 19 |
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