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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C Virus Infection
• Intervention / Treatment: Behavioral: Behavioural intervention; Diagnostic test: HCV RNA home-based test

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.

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Prins, Prof. dr.; Phone Number: +31205555243; Email: mprins@ggd.amsterdam.nl
• Study Contact Backup: Name: Kris Hage, Drs.; Phone Number: +3120555049; Email: khage@ggd.amsterdam.nl

Study Locations

• France
  • Paris, France
    • Not yet recruiting
    • Le Centre 190
    • Contact: Hayette Rougier
  • Paris, France
    • Not yet recruiting
    • Maison Chemin Vert
    • Contact: Hayette Rougier
  • Paris, France
    • Not yet recruiting
    • Service de maladies infectieuses et tropicales, Hôpital La Pitié-Salpêtrière
    • Contact: Hayette Rougier
  • Paris, France
    • Recruiting
    • Service de maladies infectieuses et tropicales, Hôpital Saint-Antoine
    • Contact: Hayette Rougier
  • Paris, France
    • Not yet recruiting
    • Service de maladies infectieuses et tropicales, Hôpital Tenon
    • Contact: Hayette Rougier
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • Universitair Medisch Centrum Utrecht
    • Contact: Tatiana Mudrikova, Dr.
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1018 WT
      • Recruiting
      • Public Health Service of Amsterdam (GGD Amsterdam)
      • Contact: Maria Prins, Prof. dr.
    • Amsterdam, Noord-Holland, Netherlands, 1061 AE
      • Recruiting
      • Onze Lieve Vrouwe Gasthuis locatie West
      • Contact: Janneke Stalenhoef, Dr.
    • Amsterdam, Noord-Holland, Netherlands, 1075 BG
      • Recruiting
      • DC Klinieken Lairesse
      • Contact: Marc van der Valk, MD PhD
    • Amsterdam, Noord-Holland, Netherlands, 1075 HN
      • Recruiting
      • Medisch Centrum Jan van Goyen
      • Contact: Dominique Verhagen, MD PhD
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Not yet recruiting
      • Vrije Universiteit Medisch Centrum
      • Contact: Edgar Peters, MD PhD
    • Amsterdam, Noord-Holland, Netherlands, 1091 AC
      • Recruiting
      • Onze Lieve Vrouwe Gasthuis locatie Oost
      • Contact: Janneke Stalenhoef, Dr.
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Recruiting
      • Amsterdam UMC - Locatie AMC
      • Contact: Marc van der Valk, MD PhD
  • Zuid-Holland
    • Den Haag, Zuid-Holland, Netherlands, 2512 VA
      • Recruiting
      • Haaglanden Medisch Centrum
      • Contact: Eliane Leyten, Dr.
    • Rotterdam, Zuid-Holland, Netherlands, 3079DZ
      • Recruiting
      • Maasstad Ziekenhuis
      • Contact: Jan den Hollander, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention I: behavioural intervention; Participants will receive the behavioural Intervention in addition to standard of care.	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.
Experimental: Intervention II: home-based testing intervention; Participants will receive the home-based testing intervention in addition to standard of care.	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.
Experimental: Intervention III: combined intervention; Participants will receive the behavioural intervention and the home-based testing intervention in addition to standard of care.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Characteristics of the study population (e.g. age, etnicity, hiv-status)	Month 0
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
The number of (home-based) tests obtained and used from other sources.	Month 0, month 6, month 12, month 18, month 24

Collaborators and Investigators

• Sponsor: Public Health Service of Amsterdam
• Collaborators: 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
• Investigators: Principal Investigator: Maria Prins, Prof. dr., Public Health Service of Amsterdam (GGD Amsterdam)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Men who have sex with men (MSM); Hepatitis C virus (HCV) reinfection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Recurrence; Hepatitis; Hepatitis A; Hepatitis C; Reinfection
• Other Study ID Numbers: NL68718.018.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No