Clinic-Based Delivery of the Young Men’s Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial
Notice bibliographique
Résumé
BACKGROUND: Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men's Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM. OBJECTIVE: This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Up program described in a recently published article by Naar et al. METHODS: This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats-clinic-based versus remote delivery-offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either CAS or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period. RESULTS: Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access. CONCLUSIONS: We are conducting YMHP in 3 cities with high rates of YMSM at risk for HIV and STIs. When adapted for real-world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by the method of delivery. TRIAL REGISTRATION: ClinicalTrials.gov NCT03488914; https://clinicaltrials.gov/ct2/show/NCT03488914 (Archived by WebCite at http://www.webcitation.org/770WaWWfi). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11184.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,007 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
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