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Exploring the screening and treatment referral service model for hepatitis C in Guangdong Province.

Exploring the screening and treatment referral service model for hepatitis C in Guangdong Province.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102501
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, syphilis

Interventions

Control group:Facility-based HCV testing
Intervention group:HCV reflex testing
Control group:No intervention
Intervention group:HCV self-testing secondary distribution model

Sponsors

Guangdong Provincial Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Sub project 1: Male to male sexual activity: 1. Have had sexual intercourse with someone of the same sex before, 2. Age 18 years old or above, 3. Physiological sex male, 4. Have not undergone syphilis or hepatitis C testing in the past 6 months, 5. Have not been diagnosed with syphilis or hepatitis C infection in the past 6 months, 6. Clearly express willingness to participate in this study and sign an informed consent form. 2. Sub project 1: Female sex workers: 1. Age 18 years old and above, 2. Physiological gender female, 3. Have engaged in commercial sexual activity in the past 6 months, 4. Have not undergone syphilis or hepatitis C testing in the past 6 months, 5. Have not been diagnosed with syphilis or hepatitis C infection in the past 6 months, 6. Clearly express willingness to participate in this study and sign an informed consent form. 3. Sub project 1: Male STD clinic visitors: 1. Age 18 years and above, 2. Physiological gender male, 3. On site STD clinic visitors, 4. No syphilis or hepatitis C testing in the past 6 months, 5. No diagnosis of syphilis or hepatitis C infection in the past 6 months, 6. Clearly express willingness to participate in this study and sign an informed consent form. 4. One person interview for sub projects: 1. Age 18 years old or above, 2. Participated in the "syphilis and hepatitis C relay test" project, 3. Does not suffer from serious mental or neurological disorders, 4. Able to provide informed consent. 5. Sub project 2: 1. Age 18 years old and above; 2. Diagnosed with hepatitis C infection within the past 6 months through hepatitis C nucleic acid testing; 3. Willing to apply for hepatitis C testing; 4. Willing to conduct follow-up visits; 5. Willing to sign an informed consent form. 6. Sub project 3: 1. Age 18 years old and above; 2. Proactively seeking or planning to undergo hepatitis C antibody testing; 3. Currently not diagnosed with hepatitis C infection; 4. Willing to participate and able to conduct follow-up on time; 5. Willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Sub project 1: Male to male sexual activity: 1. Never had sexual intercourse with someone of the same sex, 2. Under 18 years old, 3. Female biological sex, 4. Tested for syphilis and hepatitis C in the past 6 months, 5. Diagnosed with syphilis or hepatitis C infection in the past 6 months, 6. unwilling to participate in this study or sign informed consent form, 7. Previously participated in the "syphilis and hepatitis C relay testing" project. 2. Sub project 1: Female sex workers: 1. Age under 18 years old, 2. Male biological sex, 3. No commercial sexual activity in the past 6 months, 4. Have undergone syphilis and hepatitis C testing in the past 6 months, 5. Diagnosed with syphilis or hepatitis C infection in the past 6 months, 6. unwilling to participate in this study or unwilling to sign informed consent form, 7. Previously participated in the "syphilis and hepatitis C relay testing" project. 3. Sub project 1: Male STD clinic visitors: 1. Age under 18 years old, 2. Physiological gender female, 3. Non STD clinic visitors, 4. Syphilis and hepatitis C testing conducted in the past 6 months, 5. Diagnosed with syphilis or hepatitis C infection in the past 6 months, 6. Refusal to participate in this study or sign informed consent form, 7. Previous participation in the "Syphilis and Hepatitis C Relay Testing" project. 4. Interview with one person for sub projects: 1. Age under 18 years old, 2. Have not participated in the "syphilis, hepatitis C relay test" project, 3. Suffering from serious mental or neurological disorders, 4. Unable to provide informed consent. 5. Sub project 2: 1. Age under 18 years old; 2. Not diagnosed with hepatitis C infection within the past 6 months; 3. Not willing to apply for hepatitis C testing; 4. Not willing to undergo follow-up; 5. Refuse to sign the informed consent form. 6. Sub project 3: 1. Age under 18 years old; 2. Those who are unwilling to undergo hepatitis C antibody testing; 3. Currently diagnosed with hepatitis C infection; 4. Not willing to participate or unable to complete follow-up; 5. Not willing to sign an informed consent form.

Design outcomes

Primary

MeasureTime frame
The time interval from detection of HCV antibody positivity to confirmation of HCV RNA positivity among HCV antibody-positive individuals in each group;Proportion of HCV-diagnosed individuals who return to the healthcare facility for confirmatory counseling in each group;The actual distribution numbers of HCV testing kits by indexs in each group;The time interval from diagnosis to initiating treatment among HCV-diagnosed individuals in each group;Number of alters returning test results in each group;Syphilis and HCV testing rate among participants in each group;

Secondary

MeasureTime frame
Number of newly-tested alters motivated by each index;The time interval from confirmatory counseling to initiation of antiviral therapy among HCV-confirmed individuals in each group;Proportion of HCV RNA testing in the control group;Number of HCV testing kits ordered by indexs in each group;Proportion of initiating antiviral treatment among HCV-confirmed individuals in each group;Amount of donated by participants in the intervention arm;Number of alters with HCV-positive results identified by each index;HCV RNA positivity among participants in each group;Proportion of participants donated for others for Syphilis and HCV testing in the intervention arm;The amount of participants who tested positive for syphilis and hepatitis C in each group;

Countries

China

Contacts

Public ContactTang Weiming

Guangdong Provincial Center for Disease Control and Prevention

weiming_tang@med.unc.edu+86 20 87255824

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026