Efficacy of Serious Game Interventions on HCV Education for HIV Patients

HIV Infections Clinical Trial

Official title:

Efficacy of Serious Game Interventions on Hepatitis C Education for HIV-Positive Men Who Have Sex With Men: A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05497388
• Other study ID #: 202206084RIND
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• HIV Infections

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.