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

Not Applicable

Recruiting

• Conditions: Viral Hepatitis C
• Interventions: Behavioral: Serious Game; Behavioral: Traditional Health Education

• Registration Number: NCT05751889
• Lead Sponsor: National Taiwan University Hospital

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:

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.

Study Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-28
• Study Start: 2023-03-01
• Study First Posted: 2023-03-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1320

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serious Game Intervention	Serious Game	Provided with a single session serious game intervention regarding HCV and safe sexual practice.
Traditional Health Education	Traditional Health Education	Provided with a single session of traditional online healthcare education regarding HCV and safe sexual practice.

Primary Outcome Measures

Name	Time	Method
HCV incidence	48 weeks	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

Name	Time	Method
STI incidence	48 weeks	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	At weeks 12, 24 and 48 of observation	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan