ATN 151 Work-to-Prevent: Employment as HIV Prevention

Not Applicable

Completed

• Conditions: HIV Prevention
• Interventions: Behavioral: Employment Intervention

• Registration Number: NCT03313310
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The investigators aim to pilot-test a novel social and structural-level HIV intervention for YMSM and YTW of color ages 16-24.

Detailed Description

Work2Prevent will advance the science by adapting, tailoring, and pilot-testing a novel social and structural-level HIV intervention for YMSM and YTW of color ages16-24 aimed at increasing economic stability (i.e., employment) through youth empowerment and asset development, and decreasing HIV risk behaviors (i.e., sex work) associated with social and economic marginalization.

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-18
• Study Start: 2018-03-20
• Primary Completion: 2019-12-05
• Study Completion: 2019-12-05
• Results First Submitted: 2020-10-12
• Results First Submitted QC: 2020-10-12
• Status Verified: 2020-11
• Results First Posted: 2020-11-04
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

Inclusion Criteria

1. Being male or assigned male at birth (YTW)
2. Identifies as a man who has sex with men (YMSM) and/or a gay bisexual man or transgender woman/transwoman
3. Identifies as African American/Black or Hispanic/Latino
4. 16-24 years old
5. English-speaking (primary)
6. Currently unemployed but seeking employment, or employed only part-time (35 hrs or less on avg/wk)
7. Is able to attend a 4-session employment program

Phase 2

Exclusion Criteria

1. Individuals identifying as non-Hispanic White
2. Individuals not assigned male at birth
3. Individuals with a known HIV positive-status at time of consent

Phase 3 Inclusion Criteria:

1. Being male or assigned male at birth (YTW)
2. Identifies as a man who has sex with men (YMSM) and/or a gay bisexual man or transgender woman/transwoman
3. Identifies as African American/Black or Hispanic/Latino
4. 16-24 years old
5. English-speaking (primary)
6. Currently unemployed but seeking employment, or employed only part-time (35 hrs or less on avg/wk)
7. Is able to attend a 4-session employment program
8. Did not participate in Phase 2

Phase 3 Exclusion Criteria:

1. Individuals identifying as non-Hispanic White
2. Individuals not assigned male at birth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Employment Intervention	Employment Intervention	An employment intervention (iFOUR) that has been adapted from previous piloting work of focus groups, key informant interviews and a community advisory board.

Primary Outcome Measures

Name	Time	Method
Information Systems Success Model Score	Post-Intervention (up to 2 weeks after completion of intervention)	The Information Systems Success Model (ISSM) will be used to assess for intervention acceptability and satisfaction. The 21-item scale measures four sub-domains: information quality, handbook quality, perceived usefulness, and overall satisfaction. Every item is scored on a 1-5 scale, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". Responses are averaged within each sub-domain to produce four sub-domain scores. The four sub-domain scores are then averaged to produce an overall ISSM score (1-5; higher scores indicate higher acceptability/satisfaction).
Number of Participants Completing Two or More Workshop Sessions	Post-Intervention (up to 2 weeks after completion of intervention)	Workshop completion will be used to assess for intervention feasibility, as the workshop sessions are the intervention. Workshop completion will be defined as having attended at least two of the four workshop sessions and will be measured by tracking participant attendance.
Change From Baseline in Job Seeking Self-Efficacy Scale Score	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Job seeking self-efficacy is defined as one's perceived ability and confidence to perform job search and application activities. The 12-item Job Seeking Self-Efficacy (JSS) scale uses response values on a 1-10 score, with 1 being "Not at All Confident" and 10 being "Very Confident". Responses are averaged to yield a total score, with higher scores indicating higher self-efficacy. Change in JSS will be calculated by subtracting the JSS score at baseline (T1) from the JSS score at the 8-month follow-up (T3) (-9 to +9; negative change indicates decreased self-efficacy, while positive change indicates increased self-efficacy).
Change From Baseline in Protean Career Attitudes Scale Score	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Protean career attitudes (PCAs) are defined as having self-direction in the pursuit of success in one's work. PCAs have previously been found to be associated with positive career satisfaction and self-perceived success. The validated 7-item scale measures two sub-domains: self-directed attitudes and values-driven attitudes. Every item is scored on a 1-5 scale, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". Responses are averaged within each sub-domain to produce two sub-domain scores, which are then averaged as well to produce an overall PCA score. Change in PCA score will be calculated by subtracting the score at baseline (T1) from the score at the 8-month follow-up (T3) (-4 to +4; negative change indicates decreased PCAs, while positive change indicates increased PCAs).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Self-Reported Hours Worked Per Week	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Employment status will be assessed using self-reported average number of hours worked each week. Change in hours worked per week will be calculated by subtracting the baseline (T1) value from the follow-up (T3) value (negative change indicates fewer hours worked per week, while positive change indicates more hours work per week).
Change From Baseline in Self-Reported Sexual Risk Behaviors	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Sexual risk behaviors will be measured using 6 yes/no items assessing for engagement in the following behaviors during the past 6 months (this refers to the 6 months prior to the baseline visit for the first assessment and 6 months prior to the 8 month visit for the second assessment) for Phase 2, and the last 3 months for Phase 3: 1. condomless anal intercourse (CAI) with male partner of unknown HIV status; 2. anal intercourse with 3 or more males; 3. sex with male partner with a Sexually Transmitted Infection (STI); 4. CAI with HIV+ male partner; 5. anal intercourse with condom failure; 6. transactional sex work involvement; Responses will be averaged at each assessment. Change in sexual risk behaviors will be calculated by subtracting the average at baseline from the average at the 8-month follow-up (range: -1 to +1; negative change indicates fewer sexual risk behaviors, while positive change indicates more sexual risk behaviors).
Change From Baseline in Oral Chlamydia Test Result	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Chlamydia infection will be assessed at baseline and follow-up using an oral sample. The test yields a positive (1) or negative (0) result. The number of positive test results at baseline and follow-up will be calculated.
Change From Baseline in Anal Chlamydia Test Result	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Chlamydia infection will be assessed at baseline and follow up using an anal sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Change From Baseline in Urine Chlamydia Test Result	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Chlamydia infection will be assessed at baseline and follow up using a urine sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Change From Baseline in Oral Gonorrhea Test Result	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Gonorrhea infection will be assessed at baseline and follow-up using an oral sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Change From Baseline in Anal Gonorrhea Test Result	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Gonorrhea infection will be assessed at baseline and follow-up using an anal sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Change From Baseline in Urine Gonorrhea Test Result	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)	Gonorrhea infection will be assessed at baseline and follow-up using an oral sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.
Reactive HIV Result or Reported New HIV+ Status	Follow-Up (8 months for Phase 2, 3 months for Phase 3)	HIV infection will be assessed at follow-up using reactive HIV testing. Test results yield: Reactive or Non-reactive. Participants who reported HIV+ status will not be tested. A reactive HIV result will be defined as those with a "Reactive" result. Reported new HIV+ status is defined as those who report positive HIV status at follow-up and who were tested for HIV, with a non-reactive result, at baseline.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States