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The study is aimed to provide high-risk, HIV-infection, men who have sex with men (MSM) with healthcare education regarding viral hepatitis C, through either serious game intervention or traditional online health education. After the education, each participants will be followed for 48 weeks and the change of risky sexual behaviors, acquisition of HCV and other STIs will be followed during the study periods.
High-risk MSM living with HIV were participated in our study will be assigned (by randomization) to either:
After the healthcare intervention, each participants will be followed for 48 weeks. Assessment of risky sexual practice (by questionnaire), test of plasma HCV RNA and serological test of syphilis (optional), and detection of sexually-transmitted bacterial pathogens (optional) will be performed at the enrollment and then every 12 weeks during the observation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serious Game Intervention | Experimental | Provided with a single session serious game intervention regarding HCV and safe sexual practice. |
|
| Traditional Health Education | Active Comparator | Provided with a single session of traditional online healthcare education regarding HCV and safe sexual practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serious Game | Behavioral | Serious Game embedded with healthcare information regarding HCV and safe sexual practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCV incidence | The incidence rate of HCV acquisition between both arms. HCV RNA would be tested for each participants every 3 months during follow-up, and the incidence rate is calculated as following: new cases of HCV viremia / person-time of follow-up. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| STI incidence | The incidence of sexually-transmitted infection between both arms. Consultation and diagnosis of STI would be performed for each participants every 3 months during follow-up, and the incidence rate is calculated as following: new cases of STI / person-time of follow-up. | 48 weeks |
| The frequency of condom use and sexualized drug use |
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Inclusion Criteria:
High-risk MSM living with HIV, defined as:
Being able to use mobile smartphone and understand study materials
Repeat entry of study is permitted, but the interval between health education intervention should >52 weeks.
Exclusion Criteria:
The study targeted MSM living with HIV, which is the major risk group of sexually-transmitted viral hepatitis C in Taiwan.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guan-Jhou Chen, MD, MSc | Contact | +886-3-3179599 | 2070 | guanjhouchen@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chien-Ching Hung, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
However, de-identified data regarding the pre-defined outcomes or relevant characteristics could be available per request.
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D012749 | Sexually Transmitted Diseases |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Two groups will be assigned to either interventional (serious game intervention) or comparator (traditional health education).
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| Traditional Health Education | Behavioral | Reading materials regarding HCV and safe sexual practice. |
|
The frequency engaging in condomless sex and the use of sexualized drugs (within the past 3 months) will be assessed for each participant at the enrollment, week 12, 24 , and 48. We would compare the change these behaviors at week 12, 24 and 48 to the baseline to see if there are difference between the two arms. |
| At weeks 12, 24 and 48 of observation |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |