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

NCT04156945 | Active Not Recruiting

• 1 other identifier: NL68718.018.19
• Study Type: interventional
• Target: 258
• Locations: 2 countries
• Sites: 15

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.

Conditions

Hepatitis C Virus Infection

Keywords

Hepatitis C virus (HCV) reinfection; Men who have sex with men (MSM)

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (17)

• Incidence rate of HCV reinfection.

  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.

  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

Other Outcomes (9)

• 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

Study Arms (3)

Intervention I: behavioural intervention

EXPERIMENTAL

Participants will receive the behavioural Intervention in addition to standard of care.

Behavioral: Behavioural intervention

Intervention II: home-based testing intervention

EXPERIMENTAL

Participants will receive the home-based testing intervention in addition to standard of care.

Diagnostic Test: HCV RNA home-based test

Intervention III: combined intervention

EXPERIMENTAL

Participants will receive the behavioural intervention and the home-based testing intervention in addition to standard of care.

Behavioral: Behavioural intervention; Diagnostic Test: HCV RNA home-based test

Interventions

Behavioural intervention BEHAVIORAL

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.

Intervention I: behavioural intervention; Intervention III: combined intervention

HCV RNA home-based test DIAGNOSTIC_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.

Intervention II: home-based testing intervention; Intervention III: combined intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men who have sex with men (MSM)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (15)

Le Centre 190

Paris, France

Location

Maison Chemin Vert

Paris, France

Location

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

Paris, France

Location

Service de maladies infectieuses et tropicales, Hôpital Saint-Antoine

Paris, France

Location

Service de maladies infectieuses et tropicales, Hôpital Tenon

Paris, France

Location

Public Health Service of Amsterdam (GGD Amsterdam)

Amsterdam, North Holland, 1018 WT, Netherlands

Location

Onze Lieve Vrouwe Gasthuis locatie West

Amsterdam, North Holland, 1061 AE, Netherlands

Location

DC Klinieken Lairesse

Amsterdam, North Holland, 1075 BG, Netherlands

Location

Medisch Centrum Jan van Goyen

Amsterdam, North Holland, 1075 HN, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Onze Lieve Vrouwe Gasthuis locatie Oost

Amsterdam, North Holland, 1091 AC, Netherlands

Location

Amsterdam UMC - locatie AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079DZ, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, South Holland, 2512 VA, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 28597832 BACKGROUND

• 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.

  PMID: 21857492 BACKGROUND

• 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.

  PMID: 30563503 BACKGROUND

• 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.

  PMID: 36922871 DERIVED

MeSH Terms

Conditions

Hepatitis C; Reinfection; Homosexuality

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior

Study Officials

• Maria Prins, Prof. dr.

  Public Health Service of Amsterdam (GGD Amsterdam)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: November 8, 2019
• Study Start: September 14, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); NL (10)