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Hepatitis C Virus InfectionICECREAMNCT04156945

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

A study testing Behavioural intervention and HCV RNA home-based test in people with Hepatitis C Virus Infection, run by Public Health Service of Amsterdam at 15 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
Behavioural intervention and HCV RNA home-based test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
15 sitesin 2 countries
Study dates
14 Sep 2021to Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

Netherlands10 sites

  • Public Health Service of Amsterdam (GGD Amsterdam)

    Amsterdam, North Holland, 1018 WT

  • Onze Lieve Vrouwe Gasthuis locatie West

    Amsterdam, North Holland, 1061 AE

  • DC Klinieken Lairesse

    Amsterdam, North Holland, 1075 BG

  • Medisch Centrum Jan van Goyen

    Amsterdam, North Holland, 1075 HN

  • Vrije Universiteit Medisch Centrum

    Amsterdam, North Holland, 1081 HV

  • Onze Lieve Vrouwe Gasthuis locatie Oost

    Amsterdam, North Holland, 1091 AC

  • Amsterdam UMC - locatie AMC

    Amsterdam, North Holland, 1105 AZ

  • Maasstad Ziekenhuis

    Rotterdam, South Holland, 3079DZ

  • Haaglanden Medisch Centrum

    The Hague, South Holland, 2512 VA

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

France5 sites

  • Le Centre 190

    Paris

  • Maison Chemin Vert

    Paris

  • Service de maladies infectieuses et tropicales, Hôpital La Pitié-Salpêtrière

    Paris

  • Service de maladies infectieuses et tropicales, Hôpital Saint-Antoine

    Paris

  • Service de maladies infectieuses et tropicales, Hôpital Tenon

    Paris

Other trials in France

About this study

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.

Read the 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.

Being tested
Behavioural intervention, HCV RNA home-based test
Keywords
Hepatitis C virus (HCV) reinfection, Men who have sex with men (MSM)
Medical subject headings
Hepatitis C, Reinfection, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioural interventionBehavioural

    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.

  • HCV RNA home-based testDiagnostic 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.

Study groups in NCT04156945
Study groupRoleWhat they receive
Intervention I: behavioural interventionExperimentalParticipants will receive the behavioural Intervention in addition to standard of care.
Receives: Behavioral: Behavioural intervention
Intervention II: home-based testing interventionExperimentalParticipants will receive the home-based testing intervention in addition to standard of care.
Receives: Diagnostic Test: HCV RNA home-based test
Intervention III: combined interventionExperimentalParticipants will receive the behavioural intervention and the home-based testing intervention in addition to standard of care.
Receives: Behavioral: Behavioural intervention; Diagnostic Test: HCV RNA home-based test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Run-in period (0-6 months) versus intervention period (6-24 months)

Secondary outcomes (17)

  1. 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.

    Measured: Self-reported: month 0, month 6, month 12, month 18, month 24. Laboratory data: during total follow-up period of 2 years.

  2. 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.

    Measured: Month 0, month 6, month 12, month 18, month 24

  3. Change in the number of sex partners.

    Measured: Month 0, month 6, month 12, month 18, month 24

  4. Change in the number of condomless anal sex acts with casual partners.

    Measured: Month 0, month 6, month 12, month 18, month 24

  5. Change in the proportion of individuals reporting receptive condomless anal sex.

    Measured: Month 0, month 6, month 12, month 18, month 24

  6. Change in the proportion of individuals sharing sex toys.

    Measured: Month 0, month 6, month 12, month 18, month 24

  7. Change in the proportion of individuals reporting unprotected fisting.

    Measured: Month 0, month 6, month 12, month 18, month 24

  8. Change in the proportion of individuals reporting injection drug use.

    Measured: Month 0, month 6, month 12, month 18, month 24

  9. Change in the proportion of individuals sharing snoring equipment during nasally-administered drug use.

    Measured: Month 0, month 6, month 12, month 18, month 24

  10. Change in the proportion of individuals reporting ulcerative sexually transmitted infection*.

    *syphilis, genital herpes or lymphogranuloma venereum infection

    Measured: Month 0, month 6, month 12, month 18, month 24

  11. Proportion of individuals with change in any of the items of the HCV-MOSAIC risk score.

    Measured: Month 0, month 6, month 12, month 18, month 24

  12. Change in the frequency of recreational drug use before and during sex.

    Measured: Month 0, month 6, month 12, month 18, month 24

  13. 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.

    Measured: Month 0, month 6, month 12, month 18, month 24

  14. Change in the proportion of individuals sharing lubricants.

    Measured: Month 0, month 6, month 12, month 18, month 24

  15. Change in the proportion of individuals sharing anal douches.

    Measured: Month 0, month 6, month 12, month 18, month 24

  16. Change in the proportion of individuals disinfecting sex toys, skin and/or sex location.

    Measured: Month 0, month 6, month 12, month 18, month 24

  17. Change in sexual wellbeing score.

    Measured: Month 0, month 6, month 12, month 18, month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2019
  2. Study start14 Sep 2021
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04156945
Sponsor's protocol ID
NL68718.018.19
Acronym
ICECREAM
Status last verified
Aug 2024
First submitted
7 Oct 2019
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28597832

  • 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.

    PubMed 21857492

  • 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.

    PubMed 30563503

  • Hage K, Boyd A, Davidovich U, Zantkuijl P, Hoornenborg E, Matser A, Generaal E, Schinkel J, Todesco E, van der Valk M, Rougier H, Lacombe K, Prins M; ICECREAM study group. Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial. Trials. 2023 Mar 15;24(1):193. doi: 10.1186/s13063-023-07161-y.

    PubMed 36922871

Questions about this trial

What is this clinical trial studying?

A study testing Behavioural intervention and HCV RNA home-based test in people with Hepatitis C Virus Infection, run by Public Health Service of Amsterdam at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Netherlands, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the proportion at risk for HCV infection (as determined by a HCV-MOSAIC risk ≥ 2.0). (time frame: Run-in period (0-6 months) versus intervention period (6-24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04156945, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.

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