ATN 151 Work-to-Prevent: Employment as HIV Prevention (W2P)

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

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

Study Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: Employment Intervention

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: iFOUR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Brandon Hill, PhD, University of Chicago; Study Director: Lisa Strader, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 5, 2019

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Young Transgender Women; Youth Empowerment; Employment Intervention; Young Men Who Have Sex With Men
• Other Study ID Numbers: ATN 151; 5U24HD089880-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study data will be made available in the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store de-identified data from NICHD supported studies for use in secondary research. NICHD DASH is a free public resource designed for the scientific research community.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Please see DASH guidelines for access criteria.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No