NCT05751889

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

February 9, 2023

Last Update Submit

April 24, 2024

Conditions

Viral Hepatitis C

Keywords

serious gameviral hepatitis Csexually-transmitted infectionshealth belief modelharm reductionsexualized drugsbehavioral interventions

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 weeks

Secondary Outcomes (2)

  • STI incidence

    48 weeks

  • The frequency of condom use and sexualized drug use

    At weeks 12, 24 and 48 of observation

Study Arms (2)

Serious Game Intervention

EXPERIMENTAL

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

Behavioral: Serious Game

Traditional Health Education

ACTIVE COMPARATOR

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

Behavioral: Traditional Health Education

Interventions

Serious GameBEHAVIORAL

Serious Game embedded with healthcare information regarding HCV and safe sexual practice.

Serious Game Intervention
Traditional Health EducationBEHAVIORAL

Reading materials regarding HCV and safe sexual practice.

Traditional Health Education

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe study targeted MSM living with HIV, which is the major risk group of sexually-transmitted viral hepatitis C in Taiwan.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • HCV RNA positive and yet clear virus (nor reaching SVR12).
  • Admission for any acute illness (including AIDS-defining conditions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis CSexually Transmitted DiseasesHarm Reduction

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Chien-Ching Hung, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guan-Jhou Chen, MD, MSc

CONTACT

+886-3-3179599guanjhouchen@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups will be assigned to either interventional (serious game intervention) or comparator (traditional health education).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

March 2, 2023

Study Start

March 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.

Locations

TW(1)