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

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ClinicalTrials.gov Identifier: NCT03313310
Recruitment Status : Completed
First Posted : October 18, 2017
Results First Posted : November 4, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Prevention Behavioral: Employment Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A single-arm longitudinal pre/post study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Work-to-Prevent: Employment as HIV Prevention for Young Men Who Have Sex With Men (YMSM) and Young Transgender Women (YTW)
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : December 5, 2019
Actual Study Completion Date : December 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: iFOUR




Primary Outcome Measures :
  1. Information Systems Success Model Score [ Time Frame: 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).

  2. Number of Participants Completing Two or More Workshop Sessions [ Time Frame: 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.

  3. Change From Baseline in Job Seeking Self-Efficacy Scale Score [ Time Frame: 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).

  4. Change From Baseline in Protean Career Attitudes Scale Score [ Time Frame: 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 :
  1. Change From Baseline in Self-Reported Hours Worked Per Week [ Time Frame: 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).

  2. Change From Baseline in Self-Reported Sexual Risk Behaviors [ Time Frame: 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).


  3. Change From Baseline in Oral Chlamydia Test Result [ Time Frame: 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.

  4. Change From Baseline in Anal Chlamydia Test Result [ Time Frame: 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.

  5. Change From Baseline in Urine Chlamydia Test Result [ Time Frame: 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.

  6. Change From Baseline in Oral Gonorrhea Test Result [ Time Frame: 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.

  7. Change From Baseline in Anal Gonorrhea Test Result [ Time Frame: 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.

  8. Change From Baseline in Urine Gonorrhea Test Result [ Time Frame: 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.

  9. Reactive HIV Result or Reported New HIV+ Status [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313310


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Brandon Hill, PhD University of Chicago
Study Director: Lisa Strader, MPH University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Study Protocol  [PDF] August 5, 2019
Statistical Analysis Plan  [PDF] December 13, 2019

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03313310    
Other Study ID Numbers: ATN 151
5U24HD089880-02 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2017    Key Record Dates
Results First Posted: November 4, 2020
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://dash.nichd.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Youth Empowerment
Employment Intervention
Young Men Who Have Sex With Men
Young Transgender Women