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

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ClinicalTrials.gov Identifier: NCT04156945
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : December 6, 2019
Sponsor:
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
Information provided by (Responsible Party):
Prof. dr. Maria Prins, Public Health Service of Amsterdam

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Behavioral: Behavioural intervention Diagnostic Test: HCV RNA home-based test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Interventions to Curb Hepatitis C Reinfections Among Men Who Have Sex With Men
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : November 11, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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) ]
    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).


Secondary Outcome Measures :
  1. Incidence rate of HCV reinfection. [ Time Frame: Self-reported: month 0, month 6, month 12, month 18, month 24. Laboratory data: during total follow-up period of 2 years. ]
    Number of cases of HCV reinfection divided by total person-years of follow-up at risk for reinfection, self-reported and laboratory data.

  2. Incidence rate of any STI. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
    Number of cases of chlamydia, gonorrhoea, lymphogranuloma venereum (LGV), genital herpes and/or syphilis divided by total person-years, self-reported.

  3. Change in the number of sex partners. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
  4. Change in the number of condomless anal sex acts with casual partners. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
  5. Change in the proportion of individuals reporting receptive condomless anal sex. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
  6. Change in the proportion of individuals sharing sex toys. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
  7. Change in the proportion of individuals reporting unprotected fisting. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
  8. Change in the proportion of individuals reporting injection drug use. [ Time Frame: 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. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
  10. Change in the proportion of individuals reporting ulcerative sexually transmitted infection*. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
    *syphilis, genital herpes or lymphogranuloma venereum infection

  11. 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 ]
  12. Change in the frequency of recreational drug use before and during sex. [ Time Frame: 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. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
  14. Change in the proportion of individuals sharing lubricants. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
  15. Change in the proportion of individuals sharing anal douches. [ Time Frame: 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. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]
  17. Change in sexual wellbeing score. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]

Other Outcome Measures:
  1. Characteristics of the study population (e.g. age, etnicity, hiv-status) [ Time Frame: Month 0 ]
  2. 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 ]
  3. 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 ]
  4. Type of goals set in the behavioural intervention. [ Time Frame: During the intervention period, month 6 until month 24 ]
  5. Usability and acceptability of the behavioural intervention. [ Time Frame: During the intervention period, month 6 until month 24 ]
  6. 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 ]
  7. 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 ]
  8. Usability and acceptability of the testing intervention. [ Time Frame: During the intervention period, month 6 until month 24 ]
  9. The number of (home-based) tests obtained and used from other sources. [ Time Frame: Month 0, month 6, month 12, month 18, month 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men who have sex with men (MSM)
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156945


Contacts
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Contact: Maria Prins, Prof. dr. +31205555243 mprins@ggd.amsterdam.nl
Contact: Marita van de Kerkhof, MD +31205553711 mvdkerkhof@ggd.amsterdam.nl

Locations
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Netherlands
Public Health Service of Amsterdam (GGD Amsterdam) Recruiting
Amsterdam, Noord-Holland, Netherlands, 1018 WT
Contact: Maria Prins, Prof. dr.         
Onze Lieve Vrouwe Gasthuis locatie West Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1061 AE
Contact: Kees Brinkman, Prof. dr.         
DC Klinieken Lairesse Recruiting
Amsterdam, Noord-Holland, Netherlands, 1075 BG
Contact: Marc van der Valk, MD PhD         
Medisch Centrum Jan van Goyen Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1075 HN
Contact: Dominique Verhagen, MD PhD         
Vrije Universiteit Medisch Centrum Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: Edgar Peters, MD PhD         
Onze Lieve Vrouwe Gasthuis locatie Oost Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1091 AC
Contact: Kees Brinkman, Prof. dr.         
Amsterdam UMC - locatie AMC Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Marc van der Valk, MD PhD         
Sponsors and Collaborators
Public Health Service of Amsterdam
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
Investigators
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Principal Investigator: Maria Prins, Prof. dr. Public Health Service of Amsterdam (GGD Amsterdam)
  Study Documents (Full-Text)

Documents provided by Prof. dr. Maria Prins, Public Health Service of Amsterdam:
Publications:
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Responsible Party: Prof. dr. Maria Prins, Prof. dr., Public Health Service of Amsterdam
ClinicalTrials.gov Identifier: NCT04156945    
Other Study ID Numbers: NL68718.018.19
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. dr. Maria Prins, Public Health Service of Amsterdam:
Hepatitis C virus (HCV) reinfection
Men who have sex with men (MSM)
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections