Interventions to Curb Hepatitis C Reinfections Among Men Who Have Sex With Men

Last updated: August 1, 2024
Sponsor: Public Health Service of Amsterdam
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hepatitis

Liver Disorders

Treatment

HCV RNA home-based test

Behavioural intervention

Clinical Study ID

NCT04156945
NL68718.018.19
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 inthe past and/or positive anti-HCV IgG).

  • Self-reported MSM who are either (i) HIV-positive seeking care at an HIV treatmentcenter 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.

Exclusion

Exclusion Criteria:

  • 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 testingand/or a behavioural intervention targeting risk behaviour.

  • Investigators or otherwise dependent persons.

Study Design

Total Participants: 258
Treatment Group(s): 2
Primary Treatment: HCV RNA home-based test
Phase:
Study Start date:
September 14, 2021
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Le Centre 190

    Paris,
    France

    Site Not Available

  • Maison Chemin Vert

    Paris,
    France

    Site Not Available

  • Service de maladies infectieuses et tropicales, Hôpital La Pitié-Salpêtrière

    Paris,
    France

    Site Not Available

  • Service de maladies infectieuses et tropicales, Hôpital Saint-Antoine

    Paris,
    France

    Site Not Available

  • Service de maladies infectieuses et tropicales, Hôpital Tenon

    Paris,
    France

    Site Not Available

  • Amsterdam UMC - locatie AMC

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • DC Klinieken Lairesse

    Amsterdam, Noord-Holland 1075 BG
    Netherlands

    Site Not Available

  • Medisch Centrum Jan van Goyen

    Amsterdam, Noord-Holland 1075 HN
    Netherlands

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis locatie Oost

    Amsterdam, Noord-Holland 1091 AC
    Netherlands

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis locatie West

    Amsterdam, Noord-Holland 1061 AE
    Netherlands

    Site Not Available

  • Public Health Service of Amsterdam (GGD Amsterdam)

    Amsterdam, Noord-Holland 1018 WT
    Netherlands

    Site Not Available

  • Vrije Universiteit Medisch Centrum

    Amsterdam, Noord-Holland 1081 HV
    Netherlands

    Site Not Available

  • Haaglanden Medisch Centrum

    Den Haag, Zuid-Holland 2512 VA
    Netherlands

    Site Not Available

  • Maasstad Ziekenhuis

    Rotterdam, Zuid-Holland 3079DZ
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

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