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

NCT ID: NCT05751889

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-12-31

Brief Summary

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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

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High-risk MSM living with HIV were participated in our study will be assigned (by randomization) to either:

1. 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.
2. 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.

Conditions

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Viral Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups will be assigned to either interventional (serious game intervention) or comparator (traditional health education).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Serious Game Intervention

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

Group Type EXPERIMENTAL

Serious Game

Intervention Type BEHAVIORAL

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

Traditional Health Education

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

Group Type ACTIVE_COMPARATOR

Traditional Health Education

Intervention Type BEHAVIORAL

Reading materials regarding HCV and safe sexual practice.

Interventions

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Serious Game

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

Intervention Type BEHAVIORAL

Traditional Health Education

Reading materials regarding HCV and safe sexual practice.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* High-risk MSM living with HIV, defined as:

1. Had prior HCV infection, and had cleared HCV through treatment or spontaneously
2. Had any STI within the past 12 months
3. Had any unexplained elevation of liver transaminase in the past 6 months
4. 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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chien-Ching Hung, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Guan-Jhou Chen, MD, MSc

Role: CONTACT

+886-3-3179599 ext. 2070

Facility Contacts

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Guan-Jhou CHEN

Role: primary

Other Identifiers

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202212073RINC

Identifier Type: -

Identifier Source: org_study_id

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