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
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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