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Work2prevent plus: intervention structurelle pour promouvoir les soins du VIH chez les hommes de la minorité sexuelle noire

25 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

132

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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).

La description

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"

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Acceptability of intervention
Délai: 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
Délai: 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
Délai: Immediately after the intervention

Number of participants that complete at least two workshops

Immediately after the intervention
Missed sexual healthcare visits
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in hours worked per week
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Darnell Motley, PhD, University of Chicago

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 avril 2025

Achèvement primaire (Estimé)

30 octobre 2026

Achèvement de l'étude (Estimé)

22 avril 2027

Dates d'inscription aux études

Première soumission

3 mars 2025

Première soumission répondant aux critères de contrôle qualité

24 mars 2025

Première publication (Réel)

25 mars 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • IRB22-0783
  • K08MH130253 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

Data will be made available 6 months after the primary paper from the study is published.

Critères d'accès au partage IPD

Sharing criteria to be determined

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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