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

NCT04156945 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2024-08-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER
  • Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

    collaborator OTHER
  • The National Institute for STI and Aids Control in the Netherlands (Soa Aids Nederland)

    collaborator UNKNOWN
  • Julius Centre for Health Sciences and Primary Care, UMC Utrecht

    collaborator UNKNOWN
  • ANRS | Maladies infectieuses émergentes

    collaborator UNKNOWN
  • Public Health Service of Amsterdam

    lead OTHER_GOV

Principal Investigators

  • Maria Prins, Prof. dr. · Public Health Service of Amsterdam (GGD Amsterdam)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • France
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04156945 on ClinicalTrials.gov