Viral Hepatitis CNCT05751889
Serious Game Interventions to Reduce Viral Hepatitis C Among PLWH-MSM
A study testing Serious Game and Traditional Health Education in people with Viral Hepatitis C, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Viral Hepatitis C
- What is being tested?
- Serious Game and Traditional Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-risk MSM living with HIV, defined as:
- Had prior HCV infection, and had cleared HCV through treatment or spontaneously
- Had any STI within the past 12 months
- Had any unexplained elevation of liver transaminase in the past 6 months
- 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.
Who cannot join
- HCV RNA positive and yet clear virus (nor reaching SVR12).
- Admission for any acute illness (including AIDS-defining conditions)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Guan-Jhou CHEN, guanjhouchen@ntu.edu.tw
About this study
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
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.
Read the detailed description
High-risk MSM living with HIV were participated in our study will be assigned (by randomization) to either:
- 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.
- 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.
- Conditions
- Viral Hepatitis C
- Being tested
- Serious Game, Traditional Health Education
- Keywords
- serious game, viral hepatitis C, sexually-transmitted infections, health belief model, harm reduction, sexualized drugs, behavioral interventions
- Medical subject headings
- Hepatitis C, Sexually Transmitted Diseases, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious GameBehavioural
Serious Game embedded with healthcare information regarding HCV and safe sexual practice.
Traditional Health EducationBehavioural
Reading materials regarding HCV and safe sexual practice.
| Study group | Role | What they receive |
|---|---|---|
| Serious Game Intervention | Experimental | Provided with a single session serious game intervention regarding HCV and safe sexual practice. Receives: Behavioral: Serious Game |
| Traditional Health Education | Active comparator | Provided with a single session of traditional online healthcare education regarding HCV and safe sexual practice. Receives: Behavioral: Traditional Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (2)
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.
Measured: 48 weeks
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.
Measured: At weeks 12, 24 and 48 of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be assigned to either interventional (serious game intervention) or comparator (traditional health education).
- Masking
- None (open label)
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Ching Hung, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751889
- Sponsor's protocol ID
- 202212073RINC
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05751889
- Acronym / sponsor ID
- 202212073RINC
- Conditions
- Viral Hepatitis C
- Keywords
- serious game, viral hepatitis C, sexually-transmitted infections, health belief model, harm reduction, sexualized drugs, behavioral interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups will be assigned to either interventional (serious game intervention) or comparator (traditional health education).
| Arm | Type | Receives |
|---|---|---|
| Serious Game Intervention | Experimental | Behavioral: Serious GameProvided with a single session serious game intervention regarding HCV and safe sexual practice. |
| Traditional Health Education | Active comparator | Behavioral: Traditional Health EducationProvided with a single session of traditional online healthcare education regarding HCV and safe sexual practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- High-risk MSM living with HIV, defined as:
- 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.
Key exclusion criteria (2 listed)
- HCV RNA positive and yet clear virus (nor reaching SVR12).
- Admission for any acute illness (including AIDS-defining conditions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serious GameSerious Game embedded with healthcare information regarding HCV and safe sexual practice. | Behavioural | Serious Game Intervention |
| Traditional Health EducationReading materials regarding HCV and safe sexual practice. | Behavioural | Traditional Health Education |
Primary outcome
HCV incidence
Time frame: 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.
2 secondary outcomes
STI incidence
Time frame: 48 weeks
The frequency of condom use and sexualized drug use
Time frame: At weeks 12, 24 and 48 of observation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No. However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Ching Hung, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious Game and Traditional Health Education in people with Viral Hepatitis C, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guan-Jhou Chen, MD, MSc (+886-3-3179599 ext. 2070, guanjhouchen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV incidence (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.