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Work2Prevent Plus: intervento strutturale per promuovere l'assistenza all'HIV negli uomini delle minoranze sessuali nere

25 settembre 2026 aggiornato da: University of Chicago

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

Stato

Reclutamento

Condizioni

Intervento / Trattamento

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

Osservativo

Iscrizione (Stimato)

132

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

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

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

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
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
Change in participants perceived ability and confident to perform job seeking activities
Lasso di tempo: 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).

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

Average change in number of reported hours worked each week between baseline and 6 months

Baseline through 6 months
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:

  1. Condomless anal intercourse (insertive)
  2. Condomless vaginal intercourse (insertive)
  3. Condomless anal intercourse (receptive)
  4. Condomless vaginal intercourse (receptive) - trans men only
  5. Intercourse while under the influence of alcohol
  6. Intercourse while under the influence of marijuana
  7. Intercourse while under the influence of stimulants
  8. 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 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Darnell Motley, PhD, University of Chicago

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 aprile 2025

Completamento primario (Stimato)

30 ottobre 2026

Completamento dello studio (Stimato)

22 aprile 2027

Date di iscrizione allo studio

Primo inviato

3 marzo 2025

Primo inviato che soddisfa i criteri di controllo qualità

24 marzo 2025

Primo Inserito (Effettivo)

25 marzo 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 settembre 2026

Ultimo verificato

1 settembre 2026

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)?

SÌ

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

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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