Work2Prevent Summary

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ClinicalTrials.gov Number: NCT03313310 

Intervention Pilot-Test Enrollment

Work2Prevent will advance the science by adapting, tailoring, and pilot-testing a novel social and structural-level HIV intervention for YMSM (young men who have sex with men) and YTW (young transgender women) of color ages 16-24 aimed at increasing economic stability (i.e., employment) and decreasing HIV risk behaviors associated with social and economic marginalization (i.e., sex work) by utilizing a youth empowerment and asset development approach.

The primary objective is to determine the essential components of a theoretically-driven and developmentally-appropriate employment intervention aimed at increasing job self-efficacy and readiness among YMSM and YTW of color ages 16-24. Five to eight focus groups with YMSM and YTW of color who are currently employed or unemployed but seeking employment will inform the adaptation of the intervention. Key informant interviews with YMSM of color, YTW of color, and LGBT (Lesbian, Gay, Bi, Transgender)-inclusive employers will address intervention content.

The secondary objective is to review and adapt relevant intervention components from the existing evidence-based employment program for HIV-positive adults (iFOUR) to YMSM and YTW of color. The study will assemble a community advisory board (CAB) of YMSM and YTW of color, youth-serving vocational specialists, employment training and placement experts, and sexual health educators to advise the investigative team on the translation of qualitative findings into curriculum adaptations.

The tertiary objective is to refine and pilot-test the employment intervention. We will incorporate all qualitative findings into a final protocol with the iterative feedback of the CAB. Next, there will be a pilot- test of the intervention among up to 70 at-risk YMSM of color and YTW of color in a single-arm pre-/post trial, assessing feasibility and acceptability. Study outcomes, include: job self-efficacy and readiness; HIV risk behaviors; and STI and HIV infections.

Schema

Focus groups and Key Informants

Community advisory board (CAB)

 

Intervention Pilot-enrollment Test

Intervention Pilot-enrollment Test

Study Implementation

Duration

Approximately 8 months.

Sample Size

Focus Groups: 80 YMSM and YTW of color, ages 16-24

Key Informant Interviews: 64 key informant YMSM (n=8 up to 12), YTW (n=8 up to 12), and LGBT-inclusive employers (n=up to 40)

Community Advisory Board: 12 YMSM, YTW, youth-serving employment and vocational specialist, LGBT employment training and placement experts, and sexual health educators

Intervention Pilot-test: up to 70 YMSM and YTW of color, ages 16-24

Eligibility

Focus Group Inclusion Criteria

• being male or assigned male at birth (YTW);
• identifying as a man who has sex with men (YMSM) and/or gay bisexual man or transgender woman/transwoman;
• identifying as African American/Black, Hispanic/Latino, and/or a racial/ethnic minority or person of color;
• 16-24 years old;
• English-speaking (primary); and

One of the Following:

• currently employed
  or
• unemployed but seeking employment.

Key Informant Interviews Inclusion Criteria for YMSM and YTW

• being male or assigned male at birth (YTW) [YMSM/YTW only];
• identifying as a man who has sex with men (YMSM) and/or gay bisexual man or transgender woman/transwoman;
• identifying as African American/Black, Hispanic/Latino, and/or as a racial/ethnic minority or person of color;
• 16-24 years old;
• English-speaking (primary); and

One of the following:

• currently employed
  or
• unemployed but seeking employment.

Key Informant Interviews Inclusion Criteria for LGBT-Inclusive Employers

• being employed with human resources and/or having hiring responsibilities at an LGBT-inclusive company, defined as: 
  a company with a rating score of at least 80 on the Human Rights Campaign, Corporate Equality Index 2016, 
  or a company currently listed as an Out&Equal, LGBT CareerLink employer, 
  or a non-profit organization with an LGBT-focused mission, 
  or an LGBT- owned small business (<200 employees), 
  or are a company or organization participating in an LGBT job fair.
• English-speaking; and
• 18 years or older.

Intervention Pilot-Test Inclusion criteria

• being male or assigned male at birth (YTW);
• identifying as a man who has sex with men (YMSM) and/or gay bisexual man or transgender woman/transwoman;
• identifying as African American/Black, Hispanic/Latino, and/or as a racial/ethnic minority or person of color;
• 16-24 years old;
• English-speaking (primary);
• currently unemployed, but seeking employment;
• able to attend a 4-session employment program.

Exclusion Criteria

Focus Groups, Intervention Pilot-Test Exclusion Criteria

• Individuals identify as non-Hispanic White; or
• Individuals not assigned male at birth

Community Advisory Board Exclusion criteria

• Under age 18; or
• White, Asian, Native American, and any other ethnic group not Black or Latino.

There are no exclusions regarding sex/gender for the Community Advisory Board.

 

Intervention Pilot Test Outcome:

Primary Outcomes

1. Information Systems Success Model Score

The Information Systems Success Model will be used to assess for intervention acceptability and satisfaction. The 20-item scale yields a total score (20-100; higher values indicate better participant-assessed quality) and measures four sub-domains: information quality (6-30; higher values indicate better participant-assessed quality), system quality (6-30; higher values indicate better participant-assessed quality), perceived usefulness (5-25; higher values indicate higher levels of participant-perceived usefulness), and overall satisfaction (3-15; higher values indicate higher participant satisfaction). This scale has been adapted from Horvath et al. 2013.

Time Frame: post intervention (within 1 hour of intervention completion)

2. Workshop completion

Workshop completion will be used to assess for intervention feasibility. Intervention completion will be defined as having attended at least 90% of all four workshop sessions and will be measured by tracking participant attendance.

Time Frame: post intervention (within 1 hour of intervention completion)

3. Change 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 scale by Barlow et al. 2002 yields a total score (12-120; higher values indicate higher self-efficacy).

Time Frame: baseline, post intervention (8 months)

4. Change in Boundaryless Career Attitude Scale Score

Boundaryless career attitudes are defined as having a preference or orientation toward organizational, occupational, or job mobility. Boundaryless career attitudes have previously been found to be associated with positive career outcomes, including higher wages (Volmer & Spurk 2011). The validated 6-item scale by Porter et al. 2016 yields a total score (6-30; higher values indicate greater boundaryless career attitudes) and measures two sub-domains: boundaryless mindset (3-15; higher values indicate greater boundaryless mindset) and organizational mobility preference (3-15; higher values indicate a greater preference for organizational mobility).

Time Frame: baseline, post intervention (8 months)

5. Change in Protean Career Attitude Scale Score

Protean career attitudes are defined as having self-direction in the pursuit of success in one's work. Protean career attitudes have previously been found to be associated with positive career satisfaction and self-perceived success (Volmer & Spurk 2011). The validated 7-item scale by Porter et al. 2016 yields a total score (7-35; higher values indicate greater protean career attitudes) and measures two sub-domains: self-directed attitudes (4-20; higher values indicate greater protean self-directed attitudes) and values-driven attitudes (3-15; higher values indicate greater protean values-driven attitudes).

Time Frame: baseline, post intervention (8 months)

 

Secondary Outcomes:

6. Change in self-reported employment status

Employment status will be assessed using 1 yes/no item: "Are you currently employed?"

Time Frame: baseline, post intervention (8 months)

7. Change 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 3 months (this refers to the 3 months prior to the baseline visit for the first assessment and 3 months prior to the 8 month visit for the second assessment):

1. condomless anal intercourse (CAI) with male partner of unknown status
2. anal intercourse with >3 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

Time Frame: baseline, post intervention (at month 8)

8. Change in incidence of chlamydia

Chlamydia infections will be assessed at baseline and 8 month follow up. Test results yield: positive, negative, or equivocal. Incidence will be defined as those with a "positive" finding.

Time Frame: baseline, post intervention (8 months)

9. Change in incidence of gonorrhea

Gonorrhea infections will be assessed at baseline and 8 month follow up. Test results yield: positive, negative, or equivocal. Incidence will be defined as those with a "positive" finding.

Time Frame: baseline, post intervention (8 months)

10. Incidence of HIV infection

HIV infection will be assessed at 8 month follow up. Test results yield: positive, negative, or equivocal. Incidence will be defined as those with a "positive" finding.

Time Frame: post intervention (8 months)

 

Learn more about this study at the ClinicalTrials.gov website.