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

Public Health Service of Amsterdam

Status: Active, not recruiting

Conditions: Hepatitis C Virus Infection

Treatments: Diagnostic Test: HCV RNA home-based test; Behavioral: Behavioural intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04156945

NL68718.018.19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

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 testing and/or a behavioural intervention targeting risk behaviour.
• Investigators or otherwise dependent persons.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 3 patient groups

Intervention I: behavioural intervention

Experimental group

Description:

Participants will receive the behavioural Intervention in addition to standard of care.

Treatment:

Behavioral: Behavioural intervention

Intervention II: home-based testing intervention

Experimental group

Description:

Participants will receive the home-based testing intervention in addition to standard of care.

Treatment:

Diagnostic Test: HCV RNA home-based test

Intervention III: combined intervention

Experimental group

Description:

Participants will receive the behavioural intervention and the home-based testing intervention in addition to standard of care.

Treatment:

Behavioral: Behavioural intervention

Diagnostic Test: HCV RNA home-based test