Interventions to Curb Hepatitis C Reinfections Among Men Who Have Sex With Men
- Conditions
- Hepatitis C Virus Infection
- Interventions
- Behavioral: Behavioural interventionDiagnostic Test: HCV RNA home-based test
- Registration Number
- NCT04156945
- Lead Sponsor
- Public Health Service of Amsterdam
- 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 (re)infections. 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 parameters/endpoints: 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 1.1), sharing sex toys (beta 1.2), unprotected fisting (beta 0.9), injecting drug use (beta 1.4), sharing straws during nasally-administered drug use (beta 1.0), and ulcerative sexually transmitted infection (beta 1.4). Secondary outcomes include incidence of HCV reinfection, changes in the individual risk behaviour items and changes in sexual wellbeing.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 258
- Informed consent documented by signature.
- Male individual aged 18 years or older.
- History of a cured or spontaneously cleared HCV infection (positive HCV RNA test in the past and/or positive anti-HCV IgG).
- Self-reported MSM who are either (i) HIV-positive seeking care at an HIV treatment center or (ii) HIV-negative and seeking care at an STI/PrEP/sexual health center.
- Sufficient understanding of Dutch or English.
- Have internet access and an e-mail address.
- Acute or chronic HCV infection at time of enrolment.
- Under HCV treatment at time of enrolment.
- Unlikely, in the opinion of the clinician, to comply with the study procedures.
- Currently participating in an intervention study that offers extra HCV testing and/or a behavioural intervention targeting risk behaviour.
- Investigators or otherwise dependent persons.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention I: behavioural intervention Behavioural intervention Participants will receive the behavioural Intervention in addition to standard of care. Intervention II: home-based testing intervention HCV RNA home-based test Participants will receive the home-based testing intervention in addition to standard of care. Intervention III: combined intervention HCV RNA home-based test Participants will receive the behavioural intervention and the home-based testing intervention in addition to standard of care. Intervention III: combined intervention Behavioural intervention Participants will receive the behavioural intervention and the home-based testing intervention in addition to standard of care.
- Primary Outcome Measures
Name Time Method Change in the proportion at risk for HCV infection (as determined by a HCV-MOSAIC risk ≥ 2.0). Run-in period (0-6 months) versus intervention period (6-24 months) From run-in and post-randomization questionnaires, we will evaluate the proportion at risk of HCV infection (as determined by a HCV-MOSAIC score ≥ 2.0) during the run-in versus intervention periods. The HCV-MOSAIC risk score has been previously validated for acute HCV-infection and is calculated by summing up the beta-coefficients specific to six self-reported risk factors when present in the past 6 months: (i) receptive condomless anal sex (beta 1.1), (ii) sharing sex toys (beta 1.2), (iii) unprotected fisting (beta 0.9), (iv) injecting drug use (beta 1.4), (v) sharing snoring equipment during nasally-administered drug use (beta 1.0), and (vi) ulcerative sexually transmitted infection (beta 1.4).
- Secondary Outcome Measures
Name Time Method Incidence rate of HCV reinfection. Self-reported: month 0, month 6, month 12, month 18, month 24. Laboratory data: during total follow-up period of 2 years. Number of cases of HCV reinfection divided by total person-years of follow-up at risk for reinfection, self-reported and laboratory data.
Change in the proportion of individuals reporting receptive condomless anal sex. Month 0, month 6, month 12, month 18, month 24 Change in the proportion of individuals sharing sex toys. Month 0, month 6, month 12, month 18, month 24 Change in the proportion of individuals reporting unprotected fisting. Month 0, month 6, month 12, month 18, month 24 Incidence rate of any STI. Month 0, month 6, month 12, month 18, month 24 Number of cases of chlamydia, gonorrhoea, lymphogranuloma venereum (LGV), genital herpes and/or syphilis divided by total person-years, self-reported.
Change in the number of sex partners. Month 0, month 6, month 12, month 18, month 24 Change in the number of condomless anal sex acts with casual partners. Month 0, month 6, month 12, month 18, month 24 Change in the proportion of individuals reporting injection drug use. Month 0, month 6, month 12, month 18, month 24 Change in the proportion of individuals sharing snoring equipment during nasally-administered drug use. Month 0, month 6, month 12, month 18, month 24 Change in the proportion of individuals reporting ulcerative sexually transmitted infection*. Month 0, month 6, month 12, month 18, month 24 \*syphilis, genital herpes or lymphogranuloma venereum infection
Change in the frequency of individuals engaging in group sex activities, including changes in number of events and maximum number of sex partners during an event. Month 0, month 6, month 12, month 18, month 24 Change in the proportion of individuals sharing lubricants. Month 0, month 6, month 12, month 18, month 24 Change in the proportion of individuals disinfecting sex toys, skin and/or sex location. Month 0, month 6, month 12, month 18, month 24 Change in sexual wellbeing score. Month 0, month 6, month 12, month 18, month 24 Proportion of individuals with change in any of the items of the HCV-MOSAIC risk score. Month 0, month 6, month 12, month 18, month 24 Change in the frequency of recreational drug use before and during sex. Month 0, month 6, month 12, month 18, month 24 Change in the proportion of individuals sharing anal douches. Month 0, month 6, month 12, month 18, month 24
Trial Locations
- Locations (15)
Maison Chemin Vert
🇫🇷Paris, France
Service de maladies infectieuses et tropicales, Hôpital La Pitié-Salpêtrière
🇫🇷Paris, France
Service de maladies infectieuses et tropicales, Hôpital Saint-Antoine
🇫🇷Paris, France
Le Centre 190
🇫🇷Paris, France
Service de maladies infectieuses et tropicales, Hôpital Tenon
🇫🇷Paris, France
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Noord-Holland, Netherlands
Public Health Service of Amsterdam (GGD Amsterdam)
🇳🇱Amsterdam, Noord-Holland, Netherlands
Medisch Centrum Jan van Goyen
🇳🇱Amsterdam, Noord-Holland, Netherlands
Maasstad Ziekenhuis
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Onze Lieve Vrouwe Gasthuis locatie West
🇳🇱Amsterdam, Noord-Holland, Netherlands
Onze Lieve Vrouwe Gasthuis locatie Oost
🇳🇱Amsterdam, Noord-Holland, Netherlands
Haaglanden Medisch Centrum
🇳🇱Den Haag, Zuid-Holland, Netherlands
DC Klinieken Lairesse
🇳🇱Amsterdam, Noord-Holland, Netherlands
Amsterdam UMC - locatie AMC
🇳🇱Amsterdam, Noord-Holland, Netherlands