Hepatitis C Virus Infection
Conditions
Keywords
Hepatitis C virus (HCV) reinfection, Men who have sex with men (MSM)
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.
Interventions
BEHAVIORALBehavioural intervention
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.
DIAGNOSTIC_TESTHCV RNA home-based test
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.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
The National Institute for STI and Aids Control in the Netherlands (Soa Aids Nederland)
Julius Centre for Health Sciences and Primary Care, UMC Utrecht
ANRS | Maladies infectieuses émergentes
Public Health Service of Amsterdam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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 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 | — |
| Change in the proportion of individuals sharing lubricants. | 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 | — |
Other
| Measure | Time frame |
|---|---|
| The proportion of individuals reporting change in the risk behaviour identified in the goal setting module of the behavioural intervention. | During the intervention period, month 6 until month 24 |
| Website statistics (e.g., frequency of use, time spent on the behavioural intervention and the proportion of individuals completing all modules of the intervention). | During the intervention period, month 6 until month 24 |
| Type of goals set in the behavioural intervention. | During the intervention period, month 6 until month 24 |
| Usability and acceptability of the behavioural intervention. | During the intervention period, month 6 until month 24 |
| The proportion of free HCV tests used (the total number of free HCV tests used divided by the total number of distributed tests). | During the intervention period, month 6 until month 24 |
| The proportion of HCV positive test results (the total number of HCV positive test results divided by the total number of free tests used). | During the intervention period, month 6 until month 24 |
| Usability and acceptability of the testing intervention. | During the intervention period, month 6 until month 24 |
| Characteristics of the study population (e.g. age, etnicity, hiv-status) | Month 0 |
| The number of (home-based) tests obtained and used from other sources. | Month 0, month 6, month 12, month 18, month 24 |
Countries
France, Netherlands
Outcome results
None listed