HIVNCT06894199
Work2Prevent Plus: Structural Intervention to Promote HIV Care in Black Sexual Minority Men
An observational study of HIV, run by University of Chicago at 1 site in United States.
Trial summary
The goal of this observational study is to learn about the pilot test of the employment program among young men living with HIV or part of a community highly impacted by HIV. The main question it aims to answer is: What is the feasibility and acceptability of the employment program? Young male participants will attend… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- The Work Shop
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 22 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Young male cohort will be selected from primary care clinics serving young 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).
Who may be able to join
- Identifying as male
- Being ages 18-29 years old; AND
- EITHER living with HIV currently OR identifying with a population highly impacted by HIV (based on race/ethnicity or having ever had sex with another man) OR
- Being ages 18 or older
- Participated in facilitation or administrative support for the program, "The Work Shop," at a partnering community-based organization
Who cannot join
- Participated in the preceding employment intervention, "Work2Prevent"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Jordan Victorian, 773-702-5915, jordan.victorian@bsd.uchicago.edu
Darnell Motley, 773-834-5910, dmotley22@bsd.uchicago.edu
About this study
The goal of this observational study is to learn about the pilot test of the employment program among young men living with HIV or part of a community highly impacted by HIV.
The main question it aims to answer is: What is the feasibility and acceptability of the employment program?
Young male participants will attend the two day employment program and will complete four study surveys over the course of 6 months.
Employment program facilitators will complete a study survey and participate in a focus group over the course of 1 day.
Read the detailed description
For this trial, we will recruit, screen, and enroll a sample of 120 young 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.
3-months (T3) and 6-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 3 months and 6 months post-program will assess all variables addressed at T1.
- Conditions
- HIV
- Being tested
- The Work Shop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Work ShopOther
Employment intervention consists of 2 days (about 5 hours each) of interactive educational content focused on a variety of topics.
| Study group | Role | What they receive |
|---|---|---|
| Young Black sexual male | Participate in two day employment program Receives: Other: The Work Shop | |
| Employment program facilitators | Lead or support the two day employment program Receives: Other: The Work Shop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Post-Intervention, week 2
Workshop feasibility
Number of participants that complete at least two workshops
Measured: Immediately after the intervention
Missed sexual healthcare visits
Ratio of scheduled sexual healthcare visits to missed sexual healthcare visits in the past 6 months
Measured: Baseline, 3 months and 6 months
Change in participants perceived ability and confident to perform job seeking activities
Average change in score between baseline and 6 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 3- (T3) and 6-month follow-ups (T4) (-9 to +9; negative change indicates decreased self-efficacy, while positive change indicates increased self-efficacy).
Measured: Baseline through 6 months
Secondary outcomes (2)
Change in hours worked per week
Average change in number of reported hours worked each week between baseline and 6 months
Measured: Baseline through 6 months
Change in self-reported sexual risk behaviors
Average change in self-reported sexual risk behaviors from baseline through 6 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).
Measured: Baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start22 Apr 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), TaskForce Prevention & Community Services, Chicago Black Gay Men's Caucus
- Responsible party
- Sponsor
- Investigators
- Darnell Motley, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894199
- Sponsor's protocol ID
- IRB22-0783
- Other IDs
- K08MH130253
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work2Prevent Plus: Structural Intervention to Promote HIV Care in Black Sexual Minority Men
- ClinicalTrials.gov ID
- NCT06894199
- Acronym / sponsor ID
- IRB22-0783
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), TaskForce Prevention & Community Services, Chicago Black Gay Men's Caucus
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the pilot test of the employment program among young men living with HIV or part of a community highly impacted by HIV.
The main question it aims to answer is: What is the feasibility and acceptability of the employment program?
Young male participants will attend the two day employment program and will complete four study surveys over the course of 6 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 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.
3-months (T3) and 6-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 3 months and 6 months post-program will assess all variables addressed at T1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Black sexual male | – | Other: The Work ShopParticipate in two day employment program |
| Employment program facilitators | – | Other: The Work ShopLead or support the two day employment program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Young male cohort will be selected from primary care clinics serving young 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).
Key inclusion criteria (5 listed)
- Identifying as male
- Being ages 18-29 years old; AND
- EITHER living with HIV currently OR identifying with a population highly impacted by HIV (based on race/ethnicity or having ever had sex with another man) OR
- Being ages 18 or older
- Participated in facilitation or administrative support for the program, "The Work Shop," at a partnering community-based organization
Key exclusion criteria (1 listed)
- Participated in the preceding employment intervention, "Work2Prevent"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Work ShopEmployment intervention consists of 2 days (about 5 hours each) of interactive educational content focused on a variety of topics. | Other | Employment program facilitators, Young Black sexual male |
Primary outcome
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).
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).
Workshop feasibility
Time frame: Immediately after the intervention
Number of participants that complete at least two workshops
Missed sexual healthcare visits
Time frame: Baseline, 3 months and 6 months
Ratio of scheduled sexual healthcare visits to missed sexual healthcare visits in the past 6 months
Change in participants perceived ability and confident to perform job seeking activities
Time frame: Baseline through 6 months
Average change in score between baseline and 6 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 3- (T3) and 6-month follow-ups (T4) (-9 to +9; negative change indicates decreased self-efficacy, while positive change indicates increased self-efficacy).
2 secondary outcomes
Change in hours worked per week
Time frame: Baseline through 6 months
Change in self-reported sexual risk behaviors
Time frame: Baseline through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darnell Motley, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of Chicago 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?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Victorian (773-702-5915, jordan.victorian@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention (time frame: Post-Intervention, week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.