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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05497388
Other study ID # 202206084RIND
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 23, 2023
Est. completion date February 28, 2024

Study information

Verified date September 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 162
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Serious Game
using Serious Game for HCV education

Locations

Country Name City State
Taiwan Yi Ting Chen Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
12 weeks after intervention.
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