Clinical trial NCT04156945: Interventions to Curb Hepatitis C Reinfections Among Men Who Have Sex With Men
Official title: Interventions to Curb Hepatitis C Reinfections Among Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C virus (HCV) reinfection
Men who have sex with men (MSM)
Lead sponsor: Public Health Service of Amsterdam
Sponsor class: OTHER_GOV
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
name: The National Institute for STI and Aids Control in the Netherlands (Soa Aids Nederland)
name: Julius Centre for Health Sciences and Primary Care, UMC Utrecht
name: ANRS | Maladies infectieuses émergentes
First posted: 2019-11-08
Enrollment: 258
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the proportion at risk for HCV infection (as determined by a HCV-MOSAIC risk ≥ 2.0).
timeFrame: Run-in period (0-6 months) versus intervention period (6-24 months)
Secondary outcomes:
measure: Incidence rate of HCV reinfection.
timeFrame: Self-reported: month 0, month 6, month 12, month 18, month 24. Laboratory data: during total follow-up period of 2 years.
measure: Incidence rate of any STI.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the number of sex partners.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the number of condomless anal sex acts with casual partners.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the proportion of individuals reporting receptive condomless anal sex.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the proportion of individuals sharing sex toys.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the proportion of individuals reporting unprotected fisting.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the proportion of individuals reporting injection drug use.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the proportion of individuals sharing snoring equipment during nasally-administered drug use.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the proportion of individuals reporting ulcerative sexually transmitted infection*.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Proportion of individuals with change in any of the items of the HCV-MOSAIC risk score.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the frequency of recreational drug use before and during sex.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: 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.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the proportion of individuals sharing lubricants.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the proportion of individuals sharing anal douches.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in the proportion of individuals disinfecting sex toys, skin and/or sex location.
timeFrame: Month 0, month 6, month 12, month 18, month 24
measure: Change in sexual wellbeing score.
timeFrame: Month 0, month 6, month 12, month 18, month 24
Other outcomes:
measure: Characteristics of the study population (e.g. age, etnicity, hiv-status)
timeFrame: Month 0
measure: The proportion of individuals reporting change in the risk behaviour identified in the goal setting module of the behavioural intervention.
timeFrame: During the intervention period, month 6 until month 24
measure: Website statistics (e.g., frequency of use, time spent on the behavioural intervention and the proportion of individuals completing all modules of the intervention).
timeFrame: During the intervention period, month 6 until month 24
measure: Type of goals set in the behavioural intervention.
timeFrame: During the intervention period, month 6 until month 24
measure: Usability and acceptability of the behavioural intervention.
timeFrame: During the intervention period, month 6 until month 24
measure: The proportion of free HCV tests used (the total number of free HCV tests used divided by the total number of distributed tests).
timeFrame: During the intervention period, month 6 until month 24
measure: The proportion of HCV positive test results (the total number of HCV positive test results divided by the total number of free tests used).
timeFrame: During the intervention period, month 6 until month 24
measure: Usability and acceptability of the testing intervention.
timeFrame: During the intervention period, month 6 until month 24
measure: The number of (home-based) tests obtained and used from other sources.
timeFrame: Month 0, month 6, month 12, month 18, month 24
Locations:
city: Paris
country: France
facility: Le Centre 190
city: Paris
country: France
facility: Maison Chemin Vert
city: Paris
country: France
facility: Service de maladies infectieuses et tropicales, Hôpital La Pitié-Salpêtrière
city: Paris
country: France
facility: Service de maladies infectieuses et tropicales, Hôpital Saint-Antoine
city: Paris
country: France
facility: Service de maladies infectieuses et tropicales, Hôpital Tenon
city: Amsterdam
country: Netherlands
facility: Public Health Service of Amsterdam (GGD Amsterdam)
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis locatie West
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: DC Klinieken Lairesse
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Medisch Centrum Jan van Goyen
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis locatie Oost
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - locatie AMC
state: Noord-Holland
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
Study officials:
affiliation: Public Health Service of Amsterdam (GGD Amsterdam)
name: Maria Prins, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newsum AM, Stolte IG, van der Meer JT, Schinkel J, van der Valk M, Vanhommerig JW, Buve A, Danta M, Hogewoning A, Prins M; MOSAIC collaborators. Development and validation of the HCV-MOSAIC risk score to assist testing for acute hepatitis C virus (HCV) infection in HIV-infected men who have sex with men (MSM). Euro Surveill. 2017 May 25;22(21):30540. doi: 10.2807/1560-7917.ES.2017.22.21.30540.
citation: Lambers FA, Prins M, Thomas X, Molenkamp R, Kwa D, Brinkman K, van der Meer JT, Schinkel J; MOSAIC (MSM Observational Study of Acute Infection with hepatitis C) study group. Alarming incidence of hepatitis C virus re-infection after treatment of sexually acquired acute hepatitis C virus infection in HIV-infected MSM. AIDS. 2011 Nov 13;25(17):F21-7. doi: 10.1097/QAD.0b013e32834bac44.
citation: Lambers F, van der Veldt W, Prins M, Davidovich U; MOSAIC study. Changing the odds: motives for and barriers to reducing HCV-related sexual risk behaviour among HIV-infected MSM previously infected with HCV. BMC Infect Dis. 2018 Dec 18;18(1):678. doi: 10.1186/s12879-018-3571-1.