search
Back to results

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
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

First Posted
July 28, 2022
Last Updated
August 16, 2022
Sponsor
National Taiwan University Hospital
search

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

We'll reach out to this number within 24 hrs