- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06894199
Work2Prevent Plus: intervento strutturale per promuovere l'assistenza all'HIV negli uomini delle minoranze sessuali nere
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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Jordan Victorian
- Numero di telefono: 773-702-5915
- Email: jordan.victorian@bsd.uchicago.edu
Backup dei contatti dello studio
- Nome: Darnell Motley
- Numero di telefono: 773-834-5910
- Email: dmotley22@bsd.uchicago.edu
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
- Reclutamento
- University of Chicago
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Contatto:
- Jordan Victorian
- Numero di telefono: 773-702-5915
- Email: jordan.victorian@bsd.uchicago.edu
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Contatto:
- Darnell Motley
- Numero di telefono: 773-834-5910
- Email: dmotley22@bsd.uchicago.edu
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Investigatore principale:
- Darnell Motley, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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).
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- Participated in the preceding employment intervention, "Work2Prevent"
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Young Black sexual male
Participate in two day employment program |
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 |
Employment intervention consists of 2 days (about 5 hours each) of interactive educational content focused on a variety of topics. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Acceptability of intervention
Lasso di tempo: 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). |
Post-Intervention, week 2
|
|
Satisfaction with intervention
Lasso di tempo: 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). |
Post-Intervention, week 2
|
|
Workshop feasibility
Lasso di tempo: Immediately after the intervention
|
Number of participants that complete at least two workshops |
Immediately after the intervention
|
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Missed sexual healthcare visits
Lasso di tempo: Baseline, 3 months and 6 months
|
Ratio of scheduled sexual healthcare visits to missed sexual healthcare visits in the past 6 months |
Baseline, 3 months and 6 months
|
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Change in participants perceived ability and confident to perform job seeking activities
Lasso di tempo: Baseline through 6 months
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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). |
Baseline through 6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in hours worked per week
Lasso di tempo: Baseline through 6 months
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Average change in number of reported hours worked each week between baseline and 6 months |
Baseline through 6 months
|
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Change in self-reported sexual risk behaviors
Lasso di tempo: Baseline through 6 months
|
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:
|
Baseline through 6 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Darnell Motley, PhD, University of Chicago
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- IRB22-0783
- K08MH130253 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
Data will be made available 6 months after the primary paper from the study is published.
Criteri di accesso alla condivisione IPD
Sharing criteria to be determined
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .