Viral Hepatitis C
Conditions
Keywords
serious game, viral hepatitis C, sexually-transmitted infections, health belief model, harm reduction, sexualized drugs, behavioral interventions
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.
Interventions
BEHAVIORALSerious Game
Serious Game embedded with healthcare information regarding HCV and safe sexual practice.
BEHAVIORALTraditional Health Education
Reading materials regarding HCV and safe sexual practice.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Two groups will be assigned to either interventional (serious game intervention) or comparator (traditional health education).
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
Primary ContactGuan-Jhou Chen, MD, MSc
Outcome results
None listed