Trial Outcomes & Findings for Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults (NCT NCT03766165)

NCT ID: NCT03766165

Last Updated: 2020-10-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Measured at week 26

Results posted on

2020-10-22

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Control
Job announcements only Control: Participants will receive job announcements only.
Overall Study
STARTED
19
19
Overall Study
COMPLETED
19
19
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=19 Participants
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.
Control
n=19 Participants
Job announcements only Control: Participants will receive job announcements only.
Total
n=38 Participants
Total of all reporting groups
Age, Continuous
21 Years
n=5 Participants
21 Years
n=7 Participants
21 Years
n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
12 Participants
n=7 Participants
25 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
7 Participants
n=7 Participants
13 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
19 Participants
n=5 Participants
19 Participants
n=7 Participants
38 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
19 participants
n=5 Participants
19 participants
n=7 Participants
38 participants
n=5 Participants
One or more episodes of homelessness within last 12 months
19 Participants
n=5 Participants
19 Participants
n=7 Participants
38 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Measured at week 26

Population: Participants in both groups

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

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
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.
Control
n=19 Participants
Job announcements only Control: Participants will receive job announcements only.
Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys
5 Participants
9 Participants

PRIMARY outcome

Timeframe: Measured at week 23

Population: Intervention participants

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)

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
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.
Control
Job announcements only Control: Participants will receive job announcements only.
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)
11 Participants

SECONDARY outcome

Timeframe: 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

Population: All participants

Proportion of all participants who receive one or more informational text messages (description)

Outcome measures

Outcome measures
Measure
Intervention
n=38 Participants
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.
Control
Job announcements only Control: Participants will receive job announcements only.
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 4
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 5
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 6
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 7
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 8
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 9
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 10
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 11
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 12
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 13
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 14
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 15
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 16
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 17
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 18
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 19
38 Participants
Proportion of All Participants Who Receive One or More Informational Text Messages
Week 20
37 Participants

SECONDARY outcome

Timeframe: 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

Population: All participants including those in intervention arm and control arm

Proportion of all participants who respond to the text message survey (description)

Outcome measures

Outcome measures
Measure
Intervention
n=38 Participants
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.
Control
Job announcements only Control: Participants will receive job announcements only.
Proportion of All Participants Who Respond to the Text Message Survey
Week 16
23 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 17
18 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 18
16 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 19
16 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 20
15 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 21
14 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 22
15 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 23
17 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 24
16 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 25
17 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 26
14 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 1
29 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 2
33 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 3
34 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 4
31 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 5
31 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 6
29 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 7
28 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 8
23 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 9
22 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 10
25 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 11
25 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 12
23 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 13
23 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 14
23 Participants
Proportion of All Participants Who Respond to the Text Message Survey
Week 15
23 Participants

SECONDARY outcome

Timeframe: 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

Population: Intervention Participants Allowed on Site by CBO

Proportion of intervention participants who attend an educational session (description)

Outcome measures

Outcome measures
Measure
Intervention
n=17 Participants
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.
Control
Job announcements only Control: Participants will receive job announcements only.
Proportion of Intervention Participants Who Attend an Educational Session
Week 9
10 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 10
11 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 11
10 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 12
11 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 13
8 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 4
12 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 5
12 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 6
12 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 7
10 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 8
11 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 14
8 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 15
7 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 16
6 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 17
5 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 18
5 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 19
3 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 20
3 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 21
4 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 22
4 Participants
Proportion of Intervention Participants Who Attend an Educational Session
Week 23
6 Participants

SECONDARY outcome

Timeframe: 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

Population: Intervention Participants

Proportion of intervention participants who receive one or more mentor contacts (description)

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
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.
Control
Job announcements only Control: Participants will receive job announcements only.
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 6
0 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 7
0 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 8
0 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 9
11 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 10
11 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 4
0 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 5
0 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 11
8 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 12
4 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 13
7 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 14
3 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 15
4 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 16
2 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 17
2 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 18
5 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 19
4 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 20
3 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 21
2 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 22
2 Participants
Proportion of Intervention Participants Who Receive One or More Mentor Contacts
Week 23
2 Participants

SECONDARY outcome

Timeframe: 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

Population: Intervention participants

Proportion of intervention participants who spend one or more grant payments (description)

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
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.
Control
Job announcements only Control: Participants will receive job announcements only.
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 4
0 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 5
0 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 6
0 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 7
0 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 8
0 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 9
0 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 10
11 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 11
11 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 12
11 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 13
11 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 14
11 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 15
11 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 16
11 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 17
6 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 18
6 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 19
6 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 20
5 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 21
5 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 22
5 Participants
Proportion of Intervention Participants Who Spend One or More Grant Payments
Week 23
5 Participants

SECONDARY outcome

Timeframe: 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

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at week 1 and 26

Population: Participants in each group

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

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
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.
Control
n=19 Participants
Job announcements only Control: Participants will receive job announcements only.
Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month
Week 1
10 Participants
7 Participants
Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month
Week 26
7 Participants
6 Participants

SECONDARY outcome

Timeframe: 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

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at week 1 and 26

Population: Participants in each group

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

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
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.
Control
n=19 Participants
Job announcements only Control: Participants will receive job announcements only.
Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month
Week 1
16 Participants
15 Participants
Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month
Week 26
10 Participants
13 Participants

SECONDARY outcome

Timeframe: 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

Population: 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.

Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last week (description)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at week 1 and 26

Population: Participants in each group

Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last month (description)

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
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.
Control
n=19 Participants
Job announcements only Control: Participants will receive job announcements only.
Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month
Week 1
18 Participants
18 Participants
Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month
Week 26
19 Participants
14 Participants

SECONDARY outcome

Timeframe: 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

Population: 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.

Proportion of participants in each group who report one or more paid hours of work in the last week (description)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured weekly at week 1 and 26

Population: Participants in each group

Proportion of participants in each group who report one or more paid hours of work in the last month (description)

Outcome measures

Outcome measures
Measure
Intervention
n=19 Participants
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.
Control
n=19 Participants
Job announcements only Control: Participants will receive job announcements only.
Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month
Week 1
6 Participants
7 Participants
Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month
Week 26
15 Participants
9 Participants

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Larissa Jennings Mayo-Wilson

Johns Hopkins University; Indiana University

Phone: 1-812-856-0902

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place