Clinical trial NCT03313310: ATN 151 Work-to-Prevent: Employment as HIV Prevention
Official title: Work-to-Prevent: Employment as HIV Prevention for Young Men Who Have Sex With Men (YMSM) and Young Transgender Women (YTW)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Keywords: Youth Empowerment
Employment Intervention
Young Men Who Have Sex With Men
Young Transgender Women
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2017-10-18
Enrollment: 92
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm longitudinal pre/post study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Information Systems Success Model Score
timeFrame: Post-Intervention (up to 2 weeks after completion of intervention)
measure: Number of Participants Completing Two or More Workshop Sessions
timeFrame: Post-Intervention (up to 2 weeks after completion of intervention)
measure: Change From Baseline in Job Seeking Self-Efficacy Scale Score
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
measure: Change From Baseline in Protean Career Attitudes Scale Score
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Secondary outcomes:
measure: Change From Baseline in Self-Reported Hours Worked Per Week
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
measure: Change From Baseline in Self-Reported Sexual Risk Behaviors
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
measure: Change From Baseline in Oral Chlamydia Test Result
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
measure: Change From Baseline in Anal Chlamydia Test Result
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
measure: Change From Baseline in Urine Chlamydia Test Result
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
measure: Change From Baseline in Oral Gonorrhea Test Result
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
measure: Change From Baseline in Anal Gonorrhea Test Result
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
measure: Change From Baseline in Urine Gonorrhea Test Result
timeFrame: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)
measure: Reactive HIV Result or Reported New HIV+ Status
timeFrame: Follow-Up (8 months for Phase 2, 3 months for Phase 3)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Brandon Hill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Lisa Strader, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: 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.
citation: Volmer J., Spurk D. Protean and boundaryless career attitudes: relationships with subjective and objective career success. 2011;43(3):207-218.
citation: Hill BJ, Motley DN, Rosentel K, VandeVusse A, Fuller C, Bowers SME, Williams M, Kipke M, Kuhns L, Pashka N, Reisner S, DeMonte JB, Goolsby RW, Rupp BM, Slye N, Strader LC, Schneider JA, Razzano L, Garofalo R. Employment as HIV Prevention: An Employment Support Intervention for Adolescent Men Who Have Sex With Men and Adolescent Transgender Women of Color. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):31-38. doi: 10.1097/QAI.0000000000003020. Epub 2022 May 12.
citation: Hill BJ, Motley DN, Rosentel K, VandeVusse A, Garofalo R, Kuhns LM, Kipke MD, Reisner S, Rupp B, West Goolsby R, McCumber M, Renshaw L, Schneider JA. Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting. JMIR Res Protoc. 2020 Sep 11;9(9):e18051. doi: 10.2196/18051.
citation: Hill BJ, Motley DN, Rosentel K, VandeVusse A, Garofalo R, Schneider JA, Kuhns LM, Kipke MD, Reisner S, Rupp BM, Sanchez M, McCumber M, Renshaw L, Loop MS. An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 1): Protocol for Determining Essential Intervention Components Using Qualitative Interviews and Focus Groups. JMIR Res Protoc. 2020 Aug 10;9(8):e16384. doi: 10.2196/16384.
citation: Hill BJ, Motley DN, Rosentel K, VandeVusse A, Garofalo R, Schneider JA, Kuhns LM, Kipke MD, Reisner S, Rupp BM, Sanchez M, McCumber M, Renshaw L, West Goolsby R, Loop MS. An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability. JMIR Res Protoc. 2020 Aug 10;9(8):e16401. doi: 10.2196/16401.