Efficacy of Serious Game Interventions on HCV Education for HIV Patients
Primary Purpose
HIV Infections
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Serious Game
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring MSM, Hepatitis C, Health Belief Patterns, Serious Games
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable to fully participate in this study
Sites / Locations
- Yi Ting Chen
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Web for HCV education
Serious Game for HCV education
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05497388
First Posted
July 28, 2022
Last Updated
August 16, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05497388
Brief Title
Efficacy of Serious Game Interventions on HCV Education for HIV Patients
Official Title
Efficacy of Serious Game Interventions on Hepatitis C Education for HIV-Positive Men Who Have Sex With Men: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
MSM, Hepatitis C, Health Belief Patterns, Serious Games
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Web for HCV education
Arm Type
No Intervention
Arm Title
Serious Game for HCV education
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Serious Game
Intervention Description
using Serious Game for HCV education
Primary Outcome Measure Information:
Title
The effect of "serious game-assisted teaching" intervention program on MSM.
Description
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.
Time Frame
12 weeks after intervention.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Unable to fully participate in this study
Facility Information:
Facility Name
Yi Ting Chen
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Serious Game Interventions on HCV Education for HIV Patients
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