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

Hepatitis C Virus Infection Clinical Trial

— ICECREAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156945
• Other study ID #: NL68718.018.19
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Public Health Service of Amsterdam
• Contact: Maria Prins, Prof. dr.
• Phone: +31205555243
• Email: mprins[@]ggd.amsterdam.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection

Intervention

Behavioral:
• Behavioural 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 Test:
• HCV 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.

Locations

Country	Name	City	State
France	Le Centre 190	Paris
France	Maison Chemin Vert	Paris
France	Service de maladies infectieuses et tropicales, Hôpital La Pitié-Salpêtrière	Paris
France	Service de maladies infectieuses et tropicales, Hôpital Saint-Antoine	Paris
France	Service de maladies infectieuses et tropicales, Hôpital Tenon	Paris
Netherlands	Amsterdam UMC - locatie AMC	Amsterdam	Noord-Holland
Netherlands	DC Klinieken Lairesse	Amsterdam	Noord-Holland
Netherlands	Medisch Centrum Jan van Goyen	Amsterdam	Noord-Holland
Netherlands	Onze Lieve Vrouwe Gasthuis locatie Oost	Amsterdam	Noord-Holland
Netherlands	Onze Lieve Vrouwe Gasthuis locatie West	Amsterdam	Noord-Holland
Netherlands	Public Health Service of Amsterdam (GGD Amsterdam)	Amsterdam	Noord-Holland
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam	Noord-Holland
Netherlands	Haaglanden Medisch Centrum	Den Haag	Zuid-Holland
Netherlands	Maasstad Ziekenhuis	Rotterdam	Zuid-Holland
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht

Sponsors (6)

Lead Sponsor	Collaborator
Public Health Service of Amsterdam	Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), ANRS | Maladies infectieuses émergentes, Julius Centre for Health Sciences and Primary Care, UMC Utrecht, The National Institute for STI and Aids Control in the Netherlands (Soa Aids Nederland), ZonMw: The Netherlands Organisation for Health Research and Development

Countries where clinical trial is conducted

France,  Netherlands, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Characteristics of the study population (e.g. age, etnicity, hiv-status)		Month 0
Other	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
Other	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
Other	Type of goals set in the behavioural intervention.		During the intervention period, month 6 until month 24
Other	Usability and acceptability of the behavioural intervention.		During the intervention period, month 6 until month 24
Other	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
Other	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
Other	Usability and acceptability of the testing intervention.		During the intervention period, month 6 until month 24
Other	The number of (home-based) tests obtained and used from other sources.		Month 0, month 6, month 12, month 18, month 24
Primary	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	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.
Secondary	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
Secondary	Change in the number of sex partners.		Month 0, month 6, month 12, month 18, month 24
Secondary	Change in the number of condomless anal sex acts with casual partners.		Month 0, month 6, month 12, month 18, month 24
Secondary	Change in the proportion of individuals reporting receptive condomless anal sex.		Month 0, month 6, month 12, month 18, month 24
Secondary	Change in the proportion of individuals sharing sex toys.		Month 0, month 6, month 12, month 18, month 24
Secondary	Change in the proportion of individuals reporting unprotected fisting.		Month 0, month 6, month 12, month 18, month 24
Secondary	Change in the proportion of individuals reporting injection drug use.		Month 0, month 6, month 12, month 18, month 24
Secondary	Change in the proportion of individuals sharing snoring equipment during nasally-administered drug use.		Month 0, month 6, month 12, month 18, month 24
Secondary	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
Secondary	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
Secondary	Change in the frequency of recreational drug use before and during sex.		Month 0, month 6, month 12, month 18, month 24
Secondary	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
Secondary	Change in the proportion of individuals sharing lubricants.		Month 0, month 6, month 12, month 18, month 24
Secondary	Change in the proportion of individuals sharing anal douches.		Month 0, month 6, month 12, month 18, month 24
Secondary	Change in the proportion of individuals disinfecting sex toys, skin and/or sex location.		Month 0, month 6, month 12, month 18, month 24
Secondary	Change in sexual wellbeing score.		Month 0, month 6, month 12, month 18, month 24