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

NCT03313310 | Completed Results DMC

• 2 other identifiers: ATN 1515U24HD089880-02
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention

Keywords

Youth Empowerment; Employment Intervention; Young Men Who Have Sex With Men; Young Transgender Women

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (9)

• Change From Baseline in Self-Reported Hours Worked Per Week

  Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

• Change From Baseline in Self-Reported Sexual Risk Behaviors

  Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

• Change From Baseline in Oral Chlamydia Test Result

  Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

• Change From Baseline in Anal Chlamydia Test Result

  Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

• Change From Baseline in Urine Chlamydia Test Result

  Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Study Arms (1)

Employment Intervention

EXPERIMENTAL

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

Behavioral: Employment Intervention

Interventions

Employment Intervention BEHAVIORAL

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.

Also known as: iFOUR

Employment Intervention

Eligibility Criteria

• Age: 16 Years - 24 Years
• Gender Eligibility Details: Self-identifies as: (1) man who has sex with men (MSM) and/or gay or bisexual man or (2) transgender woman and/or transsexual male-to-female/transwoman.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Individuals identifying as non-Hispanic White
• Individuals not assigned male at birth
• Individuals with a known HIV positive-status at time of consent
• Being male or assigned male at birth (YTW)
• Identifies as a man who has sex with men (YMSM) and/or a gay bisexual man or transgender woman/transwoman
• Identifies as African American/Black or Hispanic/Latino
• years old
• English-speaking (primary)
• Currently unemployed but seeking employment, or employed only part-time (35 hrs or less on avg/wk)
• Is able to attend a 4-session employment program
• Did not participate in Phase 2
• Individuals identifying as non-Hispanic White
• Individuals not assigned male at birth

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (8)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23553347 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 35551157 DERIVED

• 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.

  PMID: 32915162 DERIVED

• 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.

  PMID: 32773383 DERIVED

• 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.

  PMID: 32773376 DERIVED

Results Point of Contact

• Title: Betty Rupp
• Organization: UNC Chapel Hill, ATN Coordinating Center

brupp@email.unc.edu

919-962-6603

Study Officials

• Brandon Hill, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Lisa Strader, MPH

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm longitudinal pre/post study

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 18, 2017
• Study Start: March 20, 2018
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: November 24, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available after data analyses have been completed, data has been de-identified, and all DASH submission requirements have been met and approved. Data will be available according to NICHD DASH timelines.
• Access Criteria: Please see DASH guidelines for access criteria.

Locations

US (1)