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

National Taiwan University

Status: Enrolling

Conditions: Viral Hepatitis C

Treatments: Behavioral: Traditional Health Education; Behavioral: Serious Game

Study type: Interventional

Funder types: Other

Identifiers

NCT05751889

202212073RINC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,320 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,320 participants in 2 patient groups

Serious Game Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Serious Game

Traditional Health Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Traditional Health Education