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Serious Game Interventions to Reduce Viral Hepatitis C Among PLWH-MSM

Primary Purpose

Viral Hepatitis C

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serious Game
Traditional Health Education
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Viral Hepatitis C focused on measuring serious game, viral hepatitis C, sexually-transmitted infections, health belief model, harm reduction, sexualized drugs, behavioral interventions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: High-risk MSM living with HIV, defined as: Had prior HCV infection, and had cleared HCV through treatment or spontaneously Had any STI within the past 12 months Had any unexplained elevation of liver transaminase in the past 6 months Had at least 1 unprotected anal sex during the past 6 months Being able to use mobile smartphone and understand study materials Repeat entry of study is permitted, but the interval between health education intervention should >52 weeks. Exclusion Criteria: HCV RNA positive and yet clear virus (nor reaching SVR12). Admission for any acute illness (including AIDS-defining conditions)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Serious Game Intervention

    Traditional Health Education

    Arm Description

    Provided with a single session serious game intervention regarding HCV and safe sexual practice.

    Provided with a single session of traditional online healthcare education regarding HCV and safe sexual practice.

    Outcomes

    Primary Outcome Measures

    HCV incidence
    The incidence rate of HCV acquisition between both arms. HCV RNA would be tested for each participants every 3 months during follow-up, and the incidence rate is calculated as following: new cases of HCV viremia / person-time of follow-up.

    Secondary Outcome Measures

    STI incidence
    The incidence of sexually-transmitted infection between both arms. Consultation and diagnosis of STI would be performed for each participants every 3 months during follow-up, and the incidence rate is calculated as following: new cases of STI / person-time of follow-up.
    The frequency of condom use and sexualized drug use
    The frequency engaging in condomless sex and the use of sexualized drugs (within the past 3 months) will be assessed for each participant at the enrollment, week 12, 24 , and 48. We would compare the change these behaviors at week 12, 24 and 48 to the baseline to see if there are difference between the two arms.

    Full Information

    First Posted
    February 9, 2023
    Last Updated
    February 28, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05751889
    Brief Title
    Serious Game Interventions to Reduce Viral Hepatitis C Among PLWH-MSM
    Official Title
    Reducing the Risk of Viral Hepatitis C and Other Sexually Transmitted Infections Among People Living With HIV Who Are Men Who Have Sex With Men: Efficacy of Serious Game Interventions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is aimed to provide high-risk, HIV-infection, men who have sex with men (MSM) with healthcare education regarding viral hepatitis C, through either serious game intervention or traditional online health education. After the education, each participants will be followed for 48 weeks and the change of risky sexual behaviors, acquisition of HCV and other STIs will be followed during the study periods.
    Detailed Description
    High-risk MSM living with HIV were participated in our study will be assigned (by randomization) to either: Serious game intervention: 1 single session of serious game for the participants to play (estimation to take 25-40 minutes). Hepatitis C virus (HCV)-related healthcare informations, including the severity of illness, route of transmission, preventive strategies and treatment options, would be embedded in the game. Traditional online health education (reading materials): 1 single session of healthcare education regarding HCV (with similar contents) will be provided. After the healthcare intervention, each participants will be followed for 48 weeks. Assessment of risky sexual practice (by questionnaire), test of plasma HCV RNA and serological test of syphilis (optional), and detection of sexually-transmitted bacterial pathogens (optional) will be performed at the enrollment and then every 12 weeks during the observation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Viral Hepatitis C
    Keywords
    serious game, viral hepatitis C, sexually-transmitted infections, health belief model, harm reduction, sexualized drugs, behavioral interventions

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups will be assigned to either interventional (serious game intervention) or comparator (traditional health education).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1320 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Serious Game Intervention
    Arm Type
    Experimental
    Arm Description
    Provided with a single session serious game intervention regarding HCV and safe sexual practice.
    Arm Title
    Traditional Health Education
    Arm Type
    Active Comparator
    Arm Description
    Provided with a single session of traditional online healthcare education regarding HCV and safe sexual practice.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Serious Game
    Intervention Description
    Serious Game embedded with healthcare information regarding HCV and safe sexual practice.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Traditional Health Education
    Intervention Description
    Reading materials regarding HCV and safe sexual practice.
    Primary Outcome Measure Information:
    Title
    HCV incidence
    Description
    The incidence rate of HCV acquisition between both arms. HCV RNA would be tested for each participants every 3 months during follow-up, and the incidence rate is calculated as following: new cases of HCV viremia / person-time of follow-up.
    Time Frame
    48 weeks
    Secondary Outcome Measure Information:
    Title
    STI incidence
    Description
    The incidence of sexually-transmitted infection between both arms. Consultation and diagnosis of STI would be performed for each participants every 3 months during follow-up, and the incidence rate is calculated as following: new cases of STI / person-time of follow-up.
    Time Frame
    48 weeks
    Title
    The frequency of condom use and sexualized drug use
    Description
    The frequency engaging in condomless sex and the use of sexualized drugs (within the past 3 months) will be assessed for each participant at the enrollment, week 12, 24 , and 48. We would compare the change these behaviors at week 12, 24 and 48 to the baseline to see if there are difference between the two arms.
    Time Frame
    At weeks 12, 24 and 48 of observation

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    The study targeted MSM living with HIV, which is the major risk group of sexually-transmitted viral hepatitis C in Taiwan.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: High-risk MSM living with HIV, defined as: Had prior HCV infection, and had cleared HCV through treatment or spontaneously Had any STI within the past 12 months Had any unexplained elevation of liver transaminase in the past 6 months Had at least 1 unprotected anal sex during the past 6 months Being able to use mobile smartphone and understand study materials Repeat entry of study is permitted, but the interval between health education intervention should >52 weeks. Exclusion Criteria: HCV RNA positive and yet clear virus (nor reaching SVR12). Admission for any acute illness (including AIDS-defining conditions)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guan-Jhou Chen, MD, MSc
    Phone
    +886-3-3179599
    Ext
    2070
    Email
    guanjhouchen@ntu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chien-Ching Hung, PhD
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.

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    Serious Game Interventions to Reduce Viral Hepatitis C Among PLWH-MSM

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