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Crowdsourcing to Promote HBV and HCV Testing in China

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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

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date June 20, 2018
Actual Study Start Date  ICMJE May 9, 2018
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Crowdsourcing to Promote HBV and HCV Testing in China
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Hepatitis
  • Hepatitis B
  • Hepatitis C
Intervention  ICMJE
  • 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.
  • Other: Control
    Participants will not view any images or videos promoting HBV and HCV testing.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Crowdsourced materials
  • Control
    No images or videos will be viewed, and suggestions for improving hepatitis testing materials will not be collected.
    Intervention: Other: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2018)
700
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 9, 2018
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03482388
Other Study ID Numbers  ICMJE 18-0251
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: They will be shared upon publication of the main manuscript.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Doris Duke Charitable Foundation
Investigators  ICMJE
Study Director: Joseph Tucker, MD, PhD, MA University of North Carolina, Chapel Hill
Principal Investigator: Thomas Fitzpatrick Institute for Global Health and Infectious Diseases
PRS Account University of North Carolina, Chapel Hill
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP