Clinical trial NCT06894199: Work2Prevent Plus: Structural Intervention to Promote HIV Care in Black Sexual Minority Men
Official title: Work2Prevent Plus: Structural Intervention to Promote HIV Care in Black Sexual Minority Men
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: TaskForce Prevention & Community Services
name: Chicago Black Gay Men's Caucus
First posted: 2025-03-25
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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.

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.

Eligibility criteria: 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"

Primary outcomes:
measure: Acceptability of intervention
timeFrame: Post-Intervention, week 2
measure: Satisfaction with intervention
timeFrame: Post-Intervention, week 2
measure: Workshop feasibility
timeFrame: Immediately after the intervention
measure: Missed sexual healthcare visits
timeFrame: Baseline, 6 months and 12 months
measure: Change in participants perceived ability and confident to perform job seeking activities
timeFrame: Baseline through 12 months
Secondary outcomes:
measure: Change in hours worked per week
timeFrame: Baseline through 12 months
measure: Change in self-reported sexual risk behaviors
timeFrame: Baseline through 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Darnell Motley, PhD
role: PRINCIPAL_INVESTIGATOR
References: