We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Crowdsourcing to Promote HBV and HCV Testing in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482388
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM) exposed to a crowdsourced intervention to MSM who did not receive the intervention to determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing. Participants will be randomly assigned in a 1:1 ratio to intervention or control using a computer-based allocation system. Participants will be assessed for primary and secondary outcomes four weeks after randomization.

Condition or disease Intervention/treatment Phase
Hepatitis Hepatitis B Hepatitis C Behavioral: Crowdsourced materials Other: Control Not Applicable

Detailed Description:
700 MSM will be recruited through social media operated by gay organizations in China. Eligible participants will be born biologically male, age 16 years or older, report previous anal sex with another man, and reside in China. Men self-reporting previous HBV vaccination, HBV testing, or HCV testing will be excluded. After completing a baseline online survey, participants will be randomly assigned to intervention or control arms with a 1:1 allocation ratio. The intervention will include two components: (1) a multimedia component will deliver two videos and two images promoting HBV and HCV testing developed through a crowdsourcing contest in China. (2) A participatory component will invite men to submit suggestions for how to improve crowdsourced videos and images. The control arm will not view any images or videos and will not be invited to submit suggestions. All participants will be offered reimbursement for HBV and HCV testing costs. The primary outcome is HBV and HCV test uptake confirmed through electronic submission of test report photos within four weeks of enrollment. Secondary outcomes include self-reported HBV and HCV test uptake, HBV vaccination uptake, and change in stigma toward people living with HBV measured through a follow-up survey after four weeks. Men with primary and secondary outcomes will be calculated using intention to treat and as-exposed analyses and compared using two-sided 95% confidence intervals.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned in a 1:1 ratio to the study intervention or control
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Crowdsourced Intervention to Promote Hepatitis B and C Testing Among Men Who Have Sex With Men in China: a Nationwide Online Randomized Controlled Trial
Actual Study Start Date : May 9, 2018
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : June 9, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Crowdsourced intervention
A multimedia component will deliver two videos and two images promoting HBV and HCV testing developed through a crowdsourcing contest in China. A participatory component will invite men to submit suggestions for how to improve crowdsourced videos and images.
 Behavioral: Crowdsourced materials
Among participants randomized to the intervention arm, intervention images and videos promoting HBV and HCV testing will be delivered through the WeChat platform. Men will also be invited to submit suggestions for how to improve intervention videos and images.
Control
No images or videos will be viewed, and suggestions for improving hepatitis testing materials will not be collected.
 Other: Control
Participants will not view any images or videos promoting HBV and HCV testing.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Confirmed HBV and HCV test uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had both HBsAg test uptake and anti-HCV IgG test uptake confirmed through electronic submission of a test report photo showing serology results, age of tester, sex of tester, and date of test


Secondary Outcome Measures :
  1. Confirmed HBV test uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had HBsAg test uptake through electronic submission of a test report photo showing serology results, age of tester, sex of tester, and date of test

  2. Confirmed HCV test uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had anti-HCV IgG test uptake confirmed through electronic submission of a test report photo showing serology results, age of tester, sex of tester, and date of test

  3. Self-reported HBV test uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had HBsAg uptake within four weeks of enrollment, self-reported in follow-up survey

  4. Self-reported HCV test uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had anti-HCV IgG uptake within four weeks of enrollment, self-reported in follow-up survey

  5. HBV vaccination uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had receipt of at least a one dose of the HBV vaccine within four weeks of enrollment, self-reported in follow-up survey

  6. HBV vaccination uptake among men with confirmed susceptibility to HBV infection [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men with negative HBsAg and negative anti-HBs results confirmed through electronic submission of a test report photo showing serology results, who had receipt of at least a one dose of the HBV vaccine within four weeks of enrollment, self-reported in follow-up survey

  7. HIV test uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had HIV test uptake within four weeks of enrollment, self-reported in follow-up survey

  8. Chlamydia test uptake [ Time Frame: baseline - 4 weeks after enrollment ]
    Defined as frequency of men who had chlamydia test uptake within four weeks of enrollment, self-reported in follow-up survey

  9. Gonorrhea test uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had gonorrhea test uptake within four weeks of enrollment, self-reported in follow-up survey

  10. Syphilis test uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had syphilis test uptake within four weeks of enrollment, self-reported in follow-up survey

  11. Change in stigma toward people living with HBV [ Time Frame: enrollment - 4 weeks after enrollment ]
    Continuous variable, defined as difference between Toronto Chinese HBV Stigma Scale score assessed at follow-up and baseline. Stigma toward people living with HBV will be measured at baseline and follow-up using 20 survey items that are each on a five point Likert scale. The 20 items were originally developed as the Toronto Chinese HBV Stigma Scale (potential range of 20 - 100), which has been previously validated and correlated to HBV testing behaviors among Chinese populations. Decreased stigma toward people living with HBV will be defined as a mean composite score that is less at follow-up compared to baseline.

  12. Visit with a physician after hepatitis test uptake [ Time Frame: enrollment - 4 weeks after enrollment ]
    Defined as frequency of men who had HBV and/or HCV test uptake and saw a physician to discuss hepatitis test results within four weeks of enrollment, self-reported in follow-up survey


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 16 years of age or older
  • male
  • report having had anal sex with another man at least once in the past
  • currently reside in China
  • willing to provide working mobile phone number and WeChat account

Exclusion Criteria:

  • previous HBV vaccination
  • previous HBV testing
  • previous HCV testing
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482388


Locations
Layout table for location information
China
UNC Project-China
Guangzhou, China
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Doris Duke Charitable Foundation
Investigators
Layout table for investigator information
Study Director: Joseph Tucker, MD, PhD, MA University of North Carolina, Chapel Hill
Principal Investigator: Thomas Fitzpatrick Institute for Global Health and Infectious Diseases
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03482388    
Other Study ID Numbers: 18-0251
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All de-identified data generated or analyzed during this study will be included in published articles and supplementary information files.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: They will be shared upon publication of the main manuscript.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Hepatitis
Hepatitis B
Hepatitis C
Men who have sex with men
 Crowdsourcing
China
Testing
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections