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.

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Other: The Work Shop

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 132

Contacts and Locations

• Study Contact: Name: Jordan Victorian; Phone Number: 773-702-5915; Email: jordan.victorian@bsd.uchicago.edu
• Study Contact Backup: Name: Darnell Motley; Phone Number: 773-834-5910; Email: dmotley22@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Jordan Victorian; Phone Number: 773-702-5915; Email: jordan.victorian@bsd.uchicago.edu
      • Contact: Darnell Motley; Phone Number: 773-834-5910; Email: dmotley22@bsd.uchicago.edu
      • Principal Investigator: Darnell Motley, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Young black sexual male cohort will be selected from primary care clinics serving young sexual minority males; local gathering places and events for young sexual minority males, such as night clubs, House & Ball events, and other public places that serve the LGBTQ community (e.g., LGBTQ centers).

Description

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"

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Young Black sexual male; Participate in two day employment program	Other: The Work Shop; Employment intervention consists of 2 days (about 5 hours each) of interactive educational content focused on a variety of topics.
Employment program facilitators; Lead or support the two day employment program	Other: The Work Shop; Employment intervention consists of 2 days (about 5 hours each) of interactive educational content focused on a variety of topics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of intervention	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).	Post-Intervention, week 2
Satisfaction with intervention	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).	Post-Intervention, week 2
Workshop feasibility	Number of participants that complete at least two workshops	Immediately after the intervention
Missed sexual healthcare visits	Ratio of scheduled sexual healthcare visits to missed sexual healthcare visits in the past 6 months	Baseline, 6 months and 12 months
Change in participants perceived ability and confident to perform job seeking activities	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).	Baseline through 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hours worked per week	Average change in number of reported hours worked each week between baseline and 12 months	Baseline through 12 months
Change in self-reported sexual risk behaviors	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).	Baseline through 12 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute of Mental Health (NIMH); TaskForce Prevention & Community Services; Chicago Black Gay Men's Caucus
• Investigators: Principal Investigator: Darnell Motley, PhD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): April 22, 2027

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB22-0783; K08MH130253 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A dataset that has been deidentified will be uploaded to a research data repository at the end of the study. All collected IPD from participants in the trial will be included.
• IPD Sharing Time Frame: Data will be made available 6 months after the primary paper from the study is published.
• IPD Sharing Access Criteria: Sharing criteria to be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No