Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04156945
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2019-10-07
Brief Title:
Interventions to Curb Hepatitis C Reinfections Among Men Who Have Sex With Men
Sponsor:
Public Health Service of Amsterdam
Organization:
Public Health Service of Amsterdam
Study Overview
Official Title:
Interventions to Curb Hepatitis C Reinfections Among Men Who Have Sex With Men
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICECREAM
Brief Summary:
Men who have sex with men MSM who cured from hepatitis C virus HCV infection are at substantial risk of HCV reinfection In this study the investigators aim to evaluate the effectiveness of an online behavioural intervention a home-based testing intervention and a combination of both on risk behaviour and ultimately preventing HCV reinfection and onward spread of HCV
Detailed Description:
Rationale As highly effective therapy against hepatitis C virus HCV infection is available with rapid uptake there is newfound optimism for HCV elimination Nevertheless HCV reinfections cause great concern in at risk populations including men who have sex with men MSM In the Netherlands MSM account for the majority of new HCV reinfections Although HCV treatment uptake is high in this group modelling data indicate HCV elimination would not be feasible without a reduction in risk behaviour This finding highlights the urgent need for effective interventions aimed at reducing risk behaviour and preventing reinfections in MSM
Objective To evaluate interventions aimed at reducing risk behaviour and ultimately preventing HCV reinfections and onward spread of HCV
Study design Using a 3-arm randomised trial comparing run-in and intervention periods we will evaluate the effect of two interventions and its combination on risk behaviour in MSM previously infected with HCV
Study population MSM aged 18 years or older with a history of a successfully treated or spontaneously cleared HCV infection
Interventions Intervention I is a targeted online behavioural intervention developed as part of the project Intervention II aims to increase the frequency of testing by offering an additional patient-initiated home-based HCV RNA testing service with the use of self-sampled dried blot spots Intervention III is a combination of intervention I and II
Study parametersendpoints From run-in and post-randomization questionnaires we will evaluate the proportion at risk of HCV infection as determined by the HCV-MOSAIC score as the primary outcome The HCV-MOSAIC risk score is calculated by summing up the beta coefficients specific to six self-reported risk factors when present receptive condomless anal sex beta 11 sharing sex toys beta 12 unprotected fisting beta 09 injecting drug use beta 14 sharing straws during nasally-administered drug use beta 10 and ulcerative sexually transmitted infection beta 14 Secondary outcomes include incidence of HCV reinfection changes in the individual risk behaviour items and changes in sexual wellbeing
Objective To evaluate interventions aimed at reducing risk behaviour and ultimately preventing HCV reinfections and onward spread of HCV
Study design Using a 3-arm randomised trial comparing run-in and intervention periods we will evaluate the effect of two interventions and its combination on risk behaviour in MSM previously infected with HCV
Study population MSM aged 18 years or older with a history of a successfully treated or spontaneously cleared HCV infection
Interventions Intervention I is a targeted online behavioural intervention developed as part of the project Intervention II aims to increase the frequency of testing by offering an additional patient-initiated home-based HCV RNA testing service with the use of self-sampled dried blot spots Intervention III is a combination of intervention I and II
Study parametersendpoints From run-in and post-randomization questionnaires we will evaluate the proportion at risk of HCV infection as determined by the HCV-MOSAIC score as the primary outcome The HCV-MOSAIC risk score is calculated by summing up the beta coefficients specific to six self-reported risk factors when present receptive condomless anal sex beta 11 sharing sex toys beta 12 unprotected fisting beta 09 injecting drug use beta 14 sharing straws during nasally-administered drug use beta 10 and ulcerative sexually transmitted infection beta 14 Secondary outcomes include incidence of HCV reinfection changes in the individual risk behaviour items and changes in sexual wellbeing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None