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HIV PreventionW2PNCT03313310

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

A study testing Employment Intervention in people with HIV Prevention, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 16 to 24 years, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Prevention
What is being tested?
Employment Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteUnited States
Study dates
20 Mar 2018to 5 Dec 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 24 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
HIV Prevention
Being tested
Employment Intervention
Keywords
Youth Empowerment, Employment Intervention, Young Men Who Have Sex With Men, Young Transgender Women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Employment InterventionBehavioural

    Also called iFOUR

    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.

Study groups in NCT03313310
Study groupRoleWhat they receive
Employment InterventionExperimentalAn employment intervention (iFOUR) that has been adapted from previous piloting work of focus groups, key informant interviews and a community advisory board.
Receives: Behavioral: Employment Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Post-Intervention (up to 2 weeks after completion of intervention)

  2. 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.

    Measured: Post-Intervention (up to 2 weeks after completion of intervention)

  3. 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).

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

  4. 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).

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

Secondary outcomes (9)

  1. 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).

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

  2. 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:

    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).

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

  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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2017
  2. Study start20 Mar 2018
  3. Primary completion5 Dec 2019
  4. Study completion5 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
A single-arm longitudinal pre/post study
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03313310
Sponsor's protocol ID
ATN 151
Other IDs
5U24HD089880-02
Acronym
W2P
Status last verified
Nov 2020
First submitted
20 Sep 2017
Last updated
24 Nov 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 23553347

  • 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.

    PubMed 35551157

  • 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.

    PubMed 32915162

  • 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.

    PubMed 32773383

  • 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.

    PubMed 32773376

Questions about this trial

What is this clinical trial studying?

A study testing Employment Intervention in people with HIV Prevention, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Information Systems Success Model Score (time frame: Post-Intervention (up to 2 weeks after completion of intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03313310, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.

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