Faisability and Efficacity of the Reinforced Communautary Support Program (PARC) on the Complications of Chemsex

NCT06610916 | Not Yet Recruiting

• 2 other identifiers: APHP231561IDRCB: 2024-A00651-46
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The complications associated with chemsex concern infectious disease specialists, addiction specialists, and public authorities. Chemsex is defined among men who have sex with men (MSM) and trans and non-binary individuals participating in gay hookup networks due to their specific psychological, sexual, and social characteristics. The drugs used in France are cathinones (3MMC), GBL, and methamphetamine, administered orally, nasally, rectally, and intravenously (\"\"slam\"\"). Building on change models and health education theories, the teams at 190 and Spot Beaumarchais (AIDES) have created, within their shared facilities, the Parcours d\'Accompagnement Renforcé Communautaire (PARC), a multidisciplinary and community-based program providing comprehensive care for chemsex complications. The program aims to achieve clinical benefits:

• Reducing addiction symptoms
• Decreasing somatic, psychiatric, and social risks related to chemsex
• Exploring and addressing the determinants of consumption and complications, especially psychological and psychiatric
• Improving social connections
• Maintaining life and professional goals
• Perceiving or creating new types of connections between men
• Resuming physical activity
• Improving self-esteem
• Finding a satisfying and fulfilling sexuality
• Enhancing overall quality of life The goal of this study is to ensure that the PARC program, as designed, reaches its target population, is feasible, sustainable, at an acceptable cost, and improves the conditions of the population accessing it throughout the course. Thus, in the medium term, this study will identify all success factors for deploying such a program and build a toolkit for its dissemination to other regions with similar issues but somewhat different contexts. The primary objective is to evaluate the feasibility of the PARC program in terms of implementation by measuring patient adherence to the program. The primary outcome measure is the rate of patients who completed the follow-up in the PARC program compared to the number of patients who started the PARC program (at least the inclusion visit) over 18 months. A patient is considered adherent if they have attended at least one of each type of workshop offered during the first month AND continued to attend at least 4 workshops and 2 consultations per month during months 2 and 3. The secondary objectives are:
• To evaluate the feasibility of the PARC program in terms of implementation, using the RE-AIM methodology (Glasgow):
• Reach: Does the included patient population accurately represent the target population? Does patient loss represent the most vulnerable patients?
• Intermediate Effectiveness at 3 months: (self-administered questionnaires)
• Overall quality of life
• Addiction criteria
• Somatic complications
• Social life
• Sexual quality of life
• Adoption of the intervention by professionals: Do addiction networks, CeGIDD, CSAPA, and city doctors refer their patients to the PARC program?
• Implementation of the intervention: Has the program evolved from the beginning to the end of the study? Have there been adaptations?
• Maintenance or sustainability: Is the financial model of the program sustainable and does it ensure a return on investment by analyzing the cost of care?
• To identify contextual factors that are facilitators or barriers to optimal implementation and effectiveness. (qualitative analysis)

Conditions

Chemsex; Addiction; Infections; Sexual Disorder, Physiological

Keywords

chemsex; MSM; addiction; sexual health; HIV

Outcome Measures

Primary Outcomes (1)

• Rate of patients who completed the follow-up in the PARC program as described in the model compared to the number of patients who started the PARC program (at least the inclusion visit)

  Rate of patients who completed the follow-up in the PARC program as described in the model compared to the number of patients who started the PARC program (at least the inclusion visit)

  18 months

Study Arms (1)

Reinforced Communautary Support Program (PARC)

EXPERIMENTAL

Participants will complete the initial self-questionnaire collecting baseline socio-demographic, clinical characteristics, and all intermediate effectiveness outcome criteria "before". Concurrently with their participation in the program, they will complete various intermediate effectiveness evaluation questionnaires ("after") at 3 months (end of PARC) and 6 months (Post-PARC). Healthcare professionals running the PARC program will also complete questionnaires related to implementation indicators throughout the patients' course (Adoption, Implementation, Maintenance). Qualitative interviews will be conducted with patients and relevant healthcare professionals to explore barriers and drivers to the optimal deployment of the PARC program and to examine each of the Reach, Adoption, Implementation, Maintenance indicators through an organizational approach

Other: Reinforced Communautary Support Program (PARC)

Interventions

Reinforced Communautary Support Program (PARC) OTHER

Participants will complete the initial self-questionnaire collecting baseline socio-demographic, clinical characteristics, and all intermediate effectiveness outcome criteria \"before\". Concurrently with their participation in the program, they will complete various intermediate effectiveness evaluation questionnaires (\"after\") at 3 months (end of PARC) and 6 months (Post-PARC). Healthcare professionals running the PARC program will also complete questionnaires related to implementation indicators throughout the patients\' course (Adoption, Implementation, Maintenance). Qualitative interviews will be conducted with patients and relevant healthcare professionals to explore barriers and drivers to the optimal deployment of the PARC program and to examine each of the Reach, Adoption, Implementation, Maintenance indicators through an organizational approach

Reinforced Communautary Support Program (PARC)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MSM and/or non-binary individuals, trans men or women associated with gay sexual networks
• Engaging in chemsex (as defined by the European Chemsex Forum and having consumed at least twice a cathinone and/or methamphetamine and/or GHB/GBL)
• Seeking care for chemsex
• Referred to the PARC program with the goal of reducing or stopping consumption
• Not opposed to data collection for this study
• Uncontrolled somatic or psychiatric conditions

You may not qualify if:

• Refusal to participate

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Le 190 - Centre de Santé Sexuelle / CeGIDD

Paris, 75011, France

Location

MeSH Terms

Conditions

Chemsex; Behavior, Addictive; Infections; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Compulsive Behavior; Impulsive Behavior; Genital Diseases; Urogenital Diseases

Study Officials

• Michel OHAYON, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel OHAYON, MD

CONTACT

0155253272; mohayon@le190.fr

Thibaut JEDRZEJEWSKI, MD

CONTACT

0155253272; thibautj@le190.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: September 20, 2024
• Primary Completion: March 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

FR (1)