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

HIV Prevention Clinical Trial

— W2P  

Official title:

Work-to-Prevent: Employment as HIV Prevention for Young Men Who Have Sex With Men (YMSM) and Young Transgender Women (YTW)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313310
• Other study ID #: ATN 151
• Secondary ID: 5U24HD089880-02
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: December 5, 2019

Study information

• Verified date: November 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 24 Years

Eligibility

Phase 2 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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Behavioral:
• Employment Intervention
Participants will complete 4 workshop sessions in groups of 6-12. The workshop curriculum was based on the pre-existing iFOUR program, and tailored based on feedback from a Community Advisory Board (CAB), Focus Groups, and In Depth Interviews.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Barlow J., Wright C., Cullen L. A job-seeking self-efficacy scale for people with physical disabilities:preliminary development and psychometric testing. British Journal of Guidance and Counseling. 2002;30(1):37-53.

Horvath KJ, Oakes JM, Rosser BR, Danilenko G, Vezina H, Amico KR, Williams ML, Simoni J. Feasibility, acceptability and preliminary efficacy of an online peer-to-peer social support ART adherence intervention. AIDS Behav. 2013 Jul;17(6):2031-44. doi: 10.1007/s10461-013-0469-1. — View Citation

Porter C., Woo S.E., Tak, J. Developing and Validating Short Form Protean and Boundaryless Career Attitudes Scales. Journal of Career Assessment. 2016;24(1):162-181.

Volmer J., Spurk D. Protean and boundaryless career attitudes: relationships with subjective and objective career success. 2011;43(3):207-218.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Information Systems Success Model Score	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).	Post-Intervention (up to 2 weeks after completion of intervention)
Primary	Number of Participants Completing Two or More Workshop Sessions	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.	Post-Intervention (up to 2 weeks after completion of intervention)
Primary	Change From Baseline in Job Seeking Self-Efficacy Scale Score	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).	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Primary	Change From Baseline in Protean Career Attitudes Scale Score	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).	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary	Change From Baseline in Self-Reported Hours Worked Per Week	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).	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary	Change From Baseline in Self-Reported Sexual Risk Behaviors	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: condomless anal intercourse (CAI) with male partner of unknown HIV status; anal intercourse with 3 or more males; sex with male partner with a Sexually Transmitted Infection (STI); CAI with HIV+ male partner; anal intercourse with condom failure; 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).	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary	Change From Baseline in Oral Chlamydia Test Result	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.	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary	Change From Baseline in Anal Chlamydia Test Result	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.	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary	Change From Baseline in Urine Chlamydia Test Result	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.	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary	Change From Baseline in Oral Gonorrhea Test Result	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.	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary	Change From Baseline in Anal Gonorrhea Test Result	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.	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary	Change From Baseline in Urine Gonorrhea Test Result	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.	Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary	Reactive HIV Result or Reported New HIV+ Status	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.	Follow-Up (8 months for Phase 2, 3 months for Phase 3)