Clinical trial NCT05751889: Serious Game Interventions to Reduce Viral Hepatitis C Among PLWH-MSM
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Viral Hepatitis C
Keywords: serious game
viral hepatitis C
sexually-transmitted infections
health belief model
harm reduction
sexualized drugs
behavioral interventions
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 1320
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups will be assigned to either interventional (serious game intervention) or comparator (traditional health education).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: HCV incidence
timeFrame: 48 weeks
Secondary outcomes:
measure: STI incidence
timeFrame: 48 weeks
measure: The frequency of condom use and sexualized drug use
timeFrame: At weeks 12, 24 and 48 of observation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chien-Ching Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References: