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NCT Number: NCT06894199

Work2Prevent Plus: Structural Intervention to Promote HIV Care in Black Sexual Minority Men

The goal of this observational study is to learn about the pilot test of the employment program among young Black sexual minority men.

The main question it aims to answer is: What is the feasibility and acceptability of the employment program?

Young Black sexual minority male participants will attend the two day employment program and will complete four study surveys over the course of 13 months.

Employment program facilitators will complete a study survey and participate in a focus group over the course of 1 day.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

For this trial, we will recruit, screen, and enroll a sample of 120 young black sexual minority men from our networks of community-based organizations and LGBT-serving partners. Eligible participants will be pre-screened for enrollment by a University of Chicago study research staff/project manager. Next, the research staff will explain the scope of employment program and expectations of enrollees. Those interested in enrolling in the employment program and study will then be invited to an initial session of the employment program.

The overall employment program will consist of 2 days of workshop content focused on employment skills and the relationship between work and health.

Day One. Upon arrival, the program implementers and researchers will explain the employment program and purpose of the research study. University of Chiago research staff will complete informed consent procedures with participants prior to beginning the study baseline questionnaire and ensure that all participants are capable of consenting to participate. Participants will be asked to complete a release of information to access electronic medical records for the purposes of collecting measures of viral load and clinical care visit attendance at each time point.

Baseline (T1). Prior to the start of the first session, participants will be given an iPad tablet and headphones containing a 30-35 minute audio-computer assisted self-interview (ACASI) survey. Self-assessment measures, including: sociodemographic characteristics: age, race/ethnicity, income, incarceration history, and employment history; employment and housing: job seeking self-efficacy, average hours worked in a week (last 30 days), work motivation, job-seeking behavior, and homelessness (last 3 months); and clinical care: receipt of ART/PrEP prescription (past 4 months), visits for HIV/PrEP care (past 6 months), HIV/STI testing visits (past 6 months).

Day Two. Immediate-post program (T2). At the completion of the employment program on the second day, participants will complete a 25-30 minute ACASI survey assessing the feasibility, acceptability, and satisfaction with the employment program.

6-months (T3) and 12-months (T4) post-program. Participants will be contacted by study research staff to complete additional follow-up surveys via private phone conversation or independent completion online through the REDCap data collection platform. Follow-up surveys at 6 months and 12 months post-program will assess all variables addressed at T1.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Identifying as male
  • Having ever had sex with another man
  • Being ages 18-29 years old
  • Identifying as Black or African American OR
  • Being ages 18 or older
  • Participated in facilitation or administrative support for the program, "The Work Shop," at a partnering community-based organization

Exclusion criteria

  • Participated in the preceding employment intervention, "Work2Prevent"

Treatment and study plan

The Work Shop

Other

Employment intervention consists of 2 days (about 5 hours each) of interactive educational content focused on a variety of topics.

Primary outcomes

  1. Acceptability of intervention

    Time frame: Post-Intervention, week 2

    Average score among participants of the Information Systems Success Model. The 16-item scale measures information quality, perceived usefulness, and overall satisfaction. Every item is scored on a 1-7 scale, with 1 being "Strongly Disagree" and 7 being "Strongly Agree". Responses are averaged to produce an overall ISSM score (1-7; higher scores indicate higher acceptability/satisfaction).

  2. Satisfaction with intervention

    Time frame: Post-Intervention, week 2

    Average score among participants of the Information Systems Success Model. The 16-item scale measures information quality, perceived usefulness, and overall satisfaction. Every item is scored on a 1-7 scale, with 1 being "Strongly Disagree" and 7 being "Strongly Agree". Responses are averaged to produce an overall ISSM score (1-7; higher scores indicate higher acceptability/satisfaction).

  3. Workshop feasibility

    Time frame: Immediately after the intervention

    Number of participants that complete at least two workshops

  4. Missed sexual healthcare visits

    Time frame: Baseline, 6 months and 12 months

    Ratio of scheduled sexual healthcare visits to missed sexual healthcare visits in the past 6 months

  5. Change in participants perceived ability and confident to perform job seeking activities

    Time frame: Baseline through 12 months

    Average change in score between baseline and 12 months on Job-Seeking Self-Efficacy scale on participants perceived ability and confidence to perform job seeking activities. The 12-item Job Seeking Self-Efficacy 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 6- (T3) and 12-month follow-ups (T4) (-9 to +9; negative change indicates decreased self-efficacy, while positive change indicates increased self-efficacy).

Secondary outcomes

  1. Change in hours worked per week

    Time frame: Baseline through 12 months

    Average change in number of reported hours worked each week between baseline and 12 months

  2. Change in self-reported sexual risk behaviors

    Time frame: Baseline through 12 months

    Average change in self-reported sexual risk behaviors from baseline through 12 months. Sexual risk behaviors will be measured using 7 (8 for trans male participants) yes/no items assessing for engagement in the following behaviors during the past 6 months:

    • Condomless anal intercourse (insertive)
    • Condomless vaginal intercourse (insertive)
    • Condomless anal intercourse (receptive)
    • Condomless vaginal intercourse (receptive) - trans men only
    • Intercourse while under the influence of alcohol
    • Intercourse while under the influence of marijuana
    • Intercourse while under the influence of stimulants
    • Intercourse while under the influence of opioids Responses will be averaged at each assessment. Change in sexual risk behaviors will be calculated by subtracting the baseline value from follow-up (T3 and T4, respectively) values (range: -1 to +1; negative change indicates fewer sexual risk behaviors, while positive change indicates more sexual risk behaviors).

Study contacts

Contact information is provided by the study sponsor or research team.

Darnell Motley

CONTACT

[email protected]

773-834-5910

Jordan Victorian

CONTACT

[email protected]

773-702-5915

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Chicago Black Gay Men's Caucus
  • National Institute of Mental Health (NIMH)
  • TaskForce Prevention & Community Services

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 25, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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