HIV InfectionsNCT05497388
Efficacy of Serious Game Interventions on HCV Education for HIV Patients
A study testing Serious Game in people with HIV Infections, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hepatitis C transmission has a high rate of infection and re-infection among PLWH men who have sex with men (MSM), and co-infection increases liver and HIV morbidity. The MSM group has a low level of awareness and perception of hepatitis C, and lacks health beliefs and prevention behaviors about hepatitis C. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Serious Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Feb 2023to 31 Dec 2024
- 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 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- HIV-infected men who have sex with men aged 20-45
- Can communicate in appropriate language and understand the research content
- Able to use smartphone products
Who cannot join
- Unable to fully participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Serious Game Interventions on Hepatitis C Education for HIV-Positive Men Who Have Sex With Men: A Randomized Controlled Trial
Hepatitis C transmission has a high rate of infection and re-infection among PLWH men who have sex with men (MSM), and co-infection increases liver and HIV morbidity.
The MSM group has a low level of awareness and perception of hepatitis C, and lacks health beliefs and prevention behaviors about hepatitis C. In the absence of hepatitis C cognition and health belief, it should be possible to use the health belief model to intervene and design teaching programs to improve the effectiveness of hepatitis C prevention and treatment. In the past, hepatitis C prevention education mostly focused on people who inject drugs (PWID), and was taught in traditional teaching methods. However, the common cause of hepatitis C infection among drug addicts is the sharing of needles and equipment. Education is mainly based on drug harm reduction and prevention education, while the MSM group is infected with hepatitis C mainly through risky sexual behaviors. The hepatitis C prevention education of drug addicts is adopted The content is clearly not applicable to the MSM population. Due to the stigma of PLWH's MSM in the society, individual cases will be subject to prejudice, discrimination and unfair treatment, and they are worried about being excluded from outsiders. Therefore, it is necessary to provide a learning environment with a sense of privacy, security and respect.
Serious Games is an educational game that provides a ubiquitous way of learning, using smartphones as a teaching tool, allowing learners to maintain a sense of privacy. Positive outcomes in cognitions, attitudes and behaviours related to health promotion and disease management. In terms of sexually transmitted diseases prevention measures, game content can be formulated for specific ethnic groups, and sensitive topics can be placed in the game. Without being exposed to real risks, players can simulate the consequences of various risks and corresponding prevention methods to prevent Motivate learners to solve problems and learn motivation, and give clear feedback, thereby increasing the knowledge of hepatitis C, health beliefs and the effectiveness of preventive self-efficacy.
- Conditions
- HIV Infections
- Being tested
- Serious Game
- Keywords
- MSM, Hepatitis C, Health Belief Patterns, Serious Games
- Medical subject headings
- HIV Infections, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious GameOther
using Serious Game for HCV education
| Study group | Role | What they receive |
|---|---|---|
| Web for HCV education | No intervention | Not described |
| Serious Game for HCV education | Experimental | Not described Receives: Other: Serious Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of "serious game-assisted teaching" intervention program on MSM.
The changes of Questionnaire score of hepatitis C knowledge, health beliefs, and self-efficacy will be measured, Questionnaire including:
- HCV Knowledge Scale:Scores range from 0 to 15, with higher scores representing higher knowledge of hepatitis C
- Health Belief Model (HBM):Scores range from 1 to 28, with higher scores representing more positive hepatitis C prevention beliefs.
- Self-Efficacy Scale:Scores range from 1 to 8, with higher scores representing better self-efficacy.
Measured: 12 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start23 Feb 2023
- Primary completion31 Jul 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497388
- Sponsor's protocol ID
- 202206084RIND
- Status last verified
- Oct 2024
- First submitted
- 28 Jul 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Serious Game Interventions on Hepatitis C Education for HIV-Positive Men Who Have Sex With Men: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05497388
- Acronym / sponsor ID
- 202206084RIND
- Conditions
- HIV Infections
- Keywords
- MSM, Hepatitis C, Health Belief Patterns, Serious Games
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Aug 2022 (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.
Hepatitis C transmission has a high rate of infection and re-infection among PLWH men who have sex with men (MSM), and co-infection increases liver and HIV morbidity.
The MSM group has a low level of awareness and perception of hepatitis C, and lacks health beliefs and prevention behaviors about hepatitis C. In the absence of hepatitis C cognition and health belief, it should be possible to use the health belief model to intervene and design teaching programs to improve the effectiveness of hepatitis C prevention and treatment. In the past, hepatitis C prevention education mostly focused on people who inject drugs (PWID), and was taught in traditional teaching methods. However, the common cause of hepatitis C infection among drug addicts is the sharing of needles and equipment. Education is mainly based on drug harm reduction and prevention education, while the MSM group is infected with hepatitis C mainly through risky sexual behaviors. The hepatitis C prevention education of drug addicts is adopted The content is clearly not applicable to the MSM population. Due to the stigma of PLWH's MSM in the society, individual cases will be subject to prejudice, discrimination and unfair treatment, and they are worried about being excluded from outsiders. Therefore, it is necessary to provide a learning environment with a sense of privacy, security and respect.
Serious Games is an educational game that provides a ubiquitous way of learning, using smartphones as a teaching tool, allowing learners to maintain a sense of privacy. Positive outcomes in cognitions, attitudes and behaviours related to health promotion and disease management. In terms of sexually transmitted diseases prevention measures, game content can be formulated for specific ethnic groups, and sensitive topics can be placed in the game. Without being exposed to real risks, players can simulate the consequences of various risks and corresponding prevention methods to prevent Motivate learners to solve problems and learn motivation, and give clear feedback, thereby increasing the knowledge of hepatitis C, health beliefs and the effectiveness of preventive self-efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web for HCV education | No intervention | – |
| Serious Game for HCV education | Experimental | Other: Serious Game |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HIV-infected men who have sex with men aged 20-45
- Can communicate in appropriate language and understand the research content
- Able to use smartphone products
Key exclusion criteria (1 listed)
- Unable to fully participate in this study
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 Gameusing Serious Game for HCV education | Other | Serious Game for HCV education |
Primary outcome
The effect of "serious game-assisted teaching" intervention program on MSM.
Time frame: 12 weeks after intervention.
The changes of Questionnaire score of hepatitis C knowledge, health beliefs, and self-efficacy will be measured, Questionnaire including: 1. HCV Knowledge Scale:Scores range from 0 to 15, with higher scores representing higher knowledge of hepatitis C 2. Health Belief Model (HBM):Scores range from 1 to 28, with higher scores representing more positive hepatitis C prevention beliefs. 3. Self-Efficacy Scale:Scores range from 1 to 8, with higher scores representing better self-efficacy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with HIV Infections, 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 3 inclusion and 1 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 18 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of "serious game-assisted teaching" intervention program on MSM. (time frame: 12 weeks after intervention.). 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 18 Oct 2024.