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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatitis C Virus Infection

Intervention / Treatment
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* Behavioral: Behavioural intervention
* Diagnostic Test: HCV RNA home-based test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 3-arm multicenter randomized trial. The trial will start with a 6 month run-in period (standard care) to determine at-risk behaviour under no intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention I: behavioural intervention<br>Participants will receive the behavioural Intervention in addition to standard of care. | Behavioral: Behavioural intervention<br>* An online tailored behavioural intervention. The intervention will be developed as part of the project and will be based on the principles of the Information-Motivation-Behavioural Skills (IBM) model for behavioural change. It will consist of four interactive text-based modules, and demonstration and modelling videos addressing information, motivation, and behavioural skills. The intervention will be offered on a website and able to be used on PCs as well as any mobile device. It will be provided to the participants after randomization at month 6 and available for a total period of 18 months.<br>|
| Experimental: Intervention II: home-based testing intervention<br>Participants will receive the home-based testing intervention in addition to standard of care. | Diagnostic Test: HCV RNA home-based test<br>* An additional patient-initiated home-based HCV testing service. The service offers a maximum of 4 free-of-charge HCV-RNA tests, which involves HCV testing using self-sampled dried blood spots (DBS). The DBS obtained from a finger stick will be used for HCV-RNA testing in the laboratory. DBS test kits, along with instructions and package materials for returning the test kits with the self-collected DBS sample will be provided to the participants after randomization at month 6 and available for use for a total period of 18 months.<br>|
| Experimental: Intervention III: combined intervention<br>Participants will receive the behavioural intervention and the home-based testing intervention in addition to standard of care. | Behavioral: Behavioural intervention<br>* An online tailored behavioural intervention. The intervention will be developed as part of the project and will be based on the principles of the Information-Motivation-Behavioural Skills (IBM) model for behavioural change. It will consist of four interactive text-based modules, and demonstration and modelling videos addressing information, motivation, and behavioural skills. The intervention will be offered on a website and able to be used on PCs as well as any mobile device. It will be provided to the participants after randomization at month 6 and available for a total period of 18 months.<br>Diagnostic Test: HCV RNA home-based test<br>* An additional patient-initiated home-based HCV testing service. The service offers a maximum of 4 free-of-charge HCV-RNA tests, which involves HCV testing using self-sampled dried blood spots (DBS). The DBS obtained from a finger stick will be used for HCV-RNA testing in the laboratory. DBS test kits, along with instructions and package materials for returning the test kits with the self-collected DBS sample will be provided to the participants after randomization at month 6 and available for use for a total period of 18 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the proportion at risk for HCV infection (as determined by a HCV-MOSAIC risk ≥ 2.0). | 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). | Run-in period (0-6 months) versus intervention period (6-24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of HCV reinfection. | Number of cases of HCV reinfection divided by total person-years of follow-up at risk for reinfection, self-reported and laboratory data. | Self-reported: month 0, month 6, month 12, month 18, month 24. Laboratory data: during total follow-up period of 2 years. | 
| Incidence rate of any STI. | Number of cases of chlamydia, gonorrhoea, lymphogranuloma venereum (LGV), genital herpes and/or syphilis divided by total person-years, self-reported. | Month 0, month 6, month 12, month 18, month 24 | 
| 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 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 | 
| 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*. | *syphilis, genital herpes or lymphogranuloma venereum infection | 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 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 sharing anal douches. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C virus (HCV) reinfection, Men who have sex with men (MSM)