Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610916
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Faisability and Efficacity of the Reinforced Communautary Support Program PARC on the Complications of Chemsex
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Faisability and Efficacity of the Reinforced Communautary Support Program PARC on the Complications of Chemsex
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E-PARC
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 3434slam3434
Building on change models and health education theories the teams at 190 and Spot Beaumarchais AIDES have created within their shared facilities the Parcours d39Accompagnement 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
1 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
2 To identify contextual factors that are facilitators or barriers to optimal implementation and effectiveness qualitative analysis
The expected sample size is 60 patients included over a period of 18 months Each patient will be included for a duration of 6 months and the study will last for 24 months
Once included participants will complete the initial self-questionnaire collecting baseline socio-demographic clinical characteristics and all intermediate effectiveness outcome criteria 3434before3434 Concurrently with their participation in the program they will complete various intermediate effectiveness evaluation questionnaires 3434after3434 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 patients39 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
Building on change models and health education theories the teams at 190 and Spot Beaumarchais AIDES have created within their shared facilities the Parcours d39Accompagnement 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
1 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
2 To identify contextual factors that are facilitators or barriers to optimal implementation and effectiveness qualitative analysis
The expected sample size is 60 patients included over a period of 18 months Each patient will be included for a duration of 6 months and the study will last for 24 months
Once included participants will complete the initial self-questionnaire collecting baseline socio-demographic clinical characteristics and all intermediate effectiveness outcome criteria 3434before3434 Concurrently with their participation in the program they will complete various intermediate effectiveness evaluation questionnaires 3434after3434 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 patients39 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
Detailed Description:
At 190 a community sexual health center in Paris more than one in five patients engage in chemsex The complications associated with chemsex concern infectious disease specialists addiction specialists and public authorities These complications are somatic addiction-related sexual and psychiatric They are both severe and frequent estimated difficulties between 30 and 50 of users and there is no effective treatment for stimulant addiction The drugs used in France are cathinones 3MMC GBL and methamphetamine administered orally nasally rectally and intravenously 34slam34 According to the European Chemsex Forum drug use in a sexual context is not necessarily chemsex 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
A community-based program Getting Off - Los Angeles combining group therapy and contingency management is currently the only known intervention that has shown potential benefits in reducing consumption and HIV-related risks among methamphetamine-using chemsex practitioners Reback et al 2014 Blair et al 2022 This program requires multiple practitioners and cross-disciplinary knowledge in community and medical care psychology and sexology Structures like CSAPA addiction care centers or CeGIDD sexual health centers lack this multidisciplinary approach and access to comprehensive care is limited due to the caregivers39 lack of knowledge and the users39 apprehension about judgment regarding sexuality and drugs
Building on change models and health education theories the teams at 190 and Spot Beaumarchais AIDES have created within their shared facilities the Parcours d39Accompagnement Renforcé Communautaire PARC a multidisciplinary and community-based program providing comprehensive care for chemsex complications The program aims to achieve clinical benefits in several areas
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
Since the PARC program was recently implemented at 190 the goal of this study is to assess its effectiveness through the lens of its implementation Using the RE-AIM implementation evaluation model the E-PARC study will assess the program39s transferability to the French context and its effectiveness on intermediate indicators without comparison to a control group The aim 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 The goal is not to demonstrate that all centers should adopt this program but to show that this specific expert program best fulfills its function for a vulnerable population-due to its risk behaviors and the lack of current care-by addressing each of its specific needs This is to ensure that the PARC program is known recognized and strengthened to receive as many patients as possible outside of care or referred by healthcare professionals encountering chemsex practitioners PARC is currently the only program that effectively supports chemsex practitioners is multi-component based on evidence-based medicine led by the leading French gay community sexual health center and recognized by the gay community This program encompasses all leverage factors necessary for optimal care for the target population
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 as described in the model compared to the number of patients who started the PARC program at least the inclusion visit over 18 months
The secondary objectives are
1 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
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
2 To identify contextual factors that are facilitators or barriers to optimal implementation and effectiveness
The secondary outcome measures are
1 The implementation
Reach
Number of patients offered the program
Number and reasons for refusals
Intermediate Effectiveness at 3 months
Overall quality of life WHOQOL26
E-PARC Questionnaire Impact of chemsex ad hoc chemsex complications questionnaire
All substances addiction Brief Addiction Monitor Cacciola
Craving Craving Questionnaire Weiss
Social life Multidimensional Scale of Perceived Social Support Zimet
Sexual quality of life The New Sexual Satisfaction Scale Štulhofer
Adoption
Number of primary care professionals referring patients to the PARC program original structure of these professionals
Number of non-healthcare professionals referring individuals to the PARC program original structure
Mapping of the patient referral network comparison to the community and addiction network
Implementation
Number of workshops attended by each patient
Frequency of visits to the PARC
Number of plannedactual visits
Most and least attended workshops
Evolution of the program structure during the study
Maintenance
Cost for funders for one year of PARC implementation
Cost per patient followed
2 The barriers and Facilitators
Contextual elements identified through qualitative analysis Michie with professionals and users
The eligibility criteria are
Adult men engaging in chemsex seeking care
Men who have sex with other men andor 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 andor methamphetamine andor GHBGBL
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
Refusal to participate
Eligible patients will be invited to participate in the E-PARC study information sheet provided by investigators collection of non-opposition The expected sample size is 60 patients included over a period of 18 months Each patient will be included for a duration of 6 months and the study will last for 24 months
Once included participants will complete the initial self-questionnaire collecting baseline socio-demographic clinical characteristics and all intermediate effectiveness outcome criteria 34before34 Participants will then enter the PARC program Concurrently with their participation in the program they will complete various intermediate effectiveness evaluation questionnaires 34after34 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 patients39 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 These interviews will occur throughout the study and will be conducted by a researcher trained in human and social sciences
The adherence rate to the program will be calculated as follows
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 adherence rate is calculated as number of patients considered adherent Number of patients included Descriptive analyses of collected variables for assessing implementation and all these domains will be conducted using frequencies percentages or medians interquartile ranges as appropriate and reporting the number of missing data A mapping analysis of patient flows will be performed Results of intermediate effectiveness outcome measures before and after will be compared using the Wilcoxon signed-rank test for paired samples-non-parametric-with a significance threshold of p lt 005 All analyses will be conducted using SAS and by the URC of Robert Debré Hospital to ensure quality assurance
A community-based program Getting Off - Los Angeles combining group therapy and contingency management is currently the only known intervention that has shown potential benefits in reducing consumption and HIV-related risks among methamphetamine-using chemsex practitioners Reback et al 2014 Blair et al 2022 This program requires multiple practitioners and cross-disciplinary knowledge in community and medical care psychology and sexology Structures like CSAPA addiction care centers or CeGIDD sexual health centers lack this multidisciplinary approach and access to comprehensive care is limited due to the caregivers39 lack of knowledge and the users39 apprehension about judgment regarding sexuality and drugs
Building on change models and health education theories the teams at 190 and Spot Beaumarchais AIDES have created within their shared facilities the Parcours d39Accompagnement Renforcé Communautaire PARC a multidisciplinary and community-based program providing comprehensive care for chemsex complications The program aims to achieve clinical benefits in several areas
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
Since the PARC program was recently implemented at 190 the goal of this study is to assess its effectiveness through the lens of its implementation Using the RE-AIM implementation evaluation model the E-PARC study will assess the program39s transferability to the French context and its effectiveness on intermediate indicators without comparison to a control group The aim 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 The goal is not to demonstrate that all centers should adopt this program but to show that this specific expert program best fulfills its function for a vulnerable population-due to its risk behaviors and the lack of current care-by addressing each of its specific needs This is to ensure that the PARC program is known recognized and strengthened to receive as many patients as possible outside of care or referred by healthcare professionals encountering chemsex practitioners PARC is currently the only program that effectively supports chemsex practitioners is multi-component based on evidence-based medicine led by the leading French gay community sexual health center and recognized by the gay community This program encompasses all leverage factors necessary for optimal care for the target population
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 as described in the model compared to the number of patients who started the PARC program at least the inclusion visit over 18 months
The secondary objectives are
1 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
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
2 To identify contextual factors that are facilitators or barriers to optimal implementation and effectiveness
The secondary outcome measures are
1 The implementation
Reach
Number of patients offered the program
Number and reasons for refusals
Intermediate Effectiveness at 3 months
Overall quality of life WHOQOL26
E-PARC Questionnaire Impact of chemsex ad hoc chemsex complications questionnaire
All substances addiction Brief Addiction Monitor Cacciola
Craving Craving Questionnaire Weiss
Social life Multidimensional Scale of Perceived Social Support Zimet
Sexual quality of life The New Sexual Satisfaction Scale Štulhofer
Adoption
Number of primary care professionals referring patients to the PARC program original structure of these professionals
Number of non-healthcare professionals referring individuals to the PARC program original structure
Mapping of the patient referral network comparison to the community and addiction network
Implementation
Number of workshops attended by each patient
Frequency of visits to the PARC
Number of plannedactual visits
Most and least attended workshops
Evolution of the program structure during the study
Maintenance
Cost for funders for one year of PARC implementation
Cost per patient followed
2 The barriers and Facilitators
Contextual elements identified through qualitative analysis Michie with professionals and users
The eligibility criteria are
Adult men engaging in chemsex seeking care
Men who have sex with other men andor 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 andor methamphetamine andor GHBGBL
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
Refusal to participate
Eligible patients will be invited to participate in the E-PARC study information sheet provided by investigators collection of non-opposition The expected sample size is 60 patients included over a period of 18 months Each patient will be included for a duration of 6 months and the study will last for 24 months
Once included participants will complete the initial self-questionnaire collecting baseline socio-demographic clinical characteristics and all intermediate effectiveness outcome criteria 34before34 Participants will then enter the PARC program Concurrently with their participation in the program they will complete various intermediate effectiveness evaluation questionnaires 34after34 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 patients39 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 These interviews will occur throughout the study and will be conducted by a researcher trained in human and social sciences
The adherence rate to the program will be calculated as follows
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 adherence rate is calculated as number of patients considered adherent Number of patients included Descriptive analyses of collected variables for assessing implementation and all these domains will be conducted using frequencies percentages or medians interquartile ranges as appropriate and reporting the number of missing data A mapping analysis of patient flows will be performed Results of intermediate effectiveness outcome measures before and after will be compared using the Wilcoxon signed-rank test for paired samples-non-parametric-with a significance threshold of p lt 005 All analyses will be conducted using SAS and by the URC of Robert Debré Hospital to ensure quality assurance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None