An interventional study of Behavioural intervention and HCV RNA home-based test in Hepatitis C Virus Infection, sponsored by Public Health Service of Amsterdam. Status unknown at 15 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Public Health Service of Amsterdam · Not applicable, Interventional, and Prevention
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.
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.
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 258 is above the median of 79 across 1,660 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Public Health Service of Amsterdam is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Participants will receive the behavioural Intervention in addition to standard of care.
Behavioral: Behavioural intervention
Participants will receive the home-based testing intervention in addition to standard of care.
Diagnostic Test: HCV RNA home-based test
Participants will receive the behavioural intervention and the home-based testing intervention in addition to standard of care.
Behavioral: Behavioural intervention · Diagnostic Test: HCV RNA home-based test
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.
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.
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).
Time frame: Run-in period (0-6 months) versus intervention period (6-24 months)
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.
Time frame: 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.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the number of sex partners.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the number of condomless anal sex acts with casual partners.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the proportion of individuals reporting receptive condomless anal sex.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the proportion of individuals sharing sex toys.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the proportion of individuals reporting unprotected fisting.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the proportion of individuals reporting injection drug use.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the proportion of individuals sharing snoring equipment during nasally-administered drug use.
Time frame: 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
Time frame: 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.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the frequency of recreational drug use before and during sex.
Time frame: 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.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the proportion of individuals sharing lubricants.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the proportion of individuals sharing anal douches.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in the proportion of individuals disinfecting sex toys, skin and/or sex location.
Time frame: Month 0, month 6, month 12, month 18, month 24
Change in sexual wellbeing score.
Time frame: Month 0, month 6, month 12, month 18, month 24
Characteristics of the study population (e.g. age, etnicity, hiv-status)
Time frame: Month 0
The proportion of individuals reporting change in the risk behaviour identified in the goal setting module of the behavioural intervention.
Time frame: 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).
Time frame: During the intervention period, month 6 until month 24
Type of goals set in the behavioural intervention.
Time frame: During the intervention period, month 6 until month 24
Usability and acceptability of the behavioural intervention.
Time frame: 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).
Time frame: 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).
Time frame: During the intervention period, month 6 until month 24
Usability and acceptability of the testing intervention.
Time frame: During the intervention period, month 6 until month 24
The number of (home-based) tests obtained and used from other sources.
Time frame: Month 0, month 6, month 12, month 18, month 24
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Plan to share: No
Started Sep 2021 (actual). Primary completion is estimated for Feb 2026, 53 months after the start.
Of 162 non-industry interventional studies with no phase under Hepatitis C, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 53 months is above that.
Counting every sponsor, half of 166 studies reached it within 25 months; a quarter within 15 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Public Health Service of Amsterdam