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

Viral Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751889
• Other study ID #: 202212073RINC
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: National Taiwan University Hospital
• Contact: Guan-Jhou Chen, MD, MSc
• Phone: +886-3-3179599
• Email: guanjhouchen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1320
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Viral Hepatitis C

Intervention

Behavioral:
• Serious Game
Serious Game embedded with healthcare information regarding HCV and safe sexual practice.
• Traditional Health Education
Reading materials regarding HCV and safe sexual practice.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	48 weeks
Secondary	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.	At weeks 12, 24 and 48 of observation