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Crowdsourcing to Promote HBV and HCV Testing in China

Primary Purpose

Hepatitis, Hepatitis B, Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Crowdsourced materials
Control
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis focused on measuring Hepatitis, Hepatitis B, Hepatitis C, Men who have sex with men, Crowdsourcing, China, Testing

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • UNC Project-China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Crowdsourced intervention

Control

Arm Description

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.

No images or videos will be viewed, and suggestions for improving hepatitis testing materials will not be collected.

Outcomes

Primary Outcome Measures

Confirmed HBV and HCV test uptake
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

Confirmed HBV test uptake
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
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
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
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
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
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
Defined as frequency of men who had HIV test uptake within four weeks of enrollment, self-reported in follow-up survey
Chlamydia test uptake
Defined as frequency of men who had chlamydia test uptake within four weeks of enrollment, self-reported in follow-up survey
Gonorrhea test uptake
Defined as frequency of men who had gonorrhea test uptake within four weeks of enrollment, self-reported in follow-up survey
Syphilis test uptake
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
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
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

Full Information

First Posted
March 22, 2018
Last Updated
June 18, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Doris Duke Charitable Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03482388
Brief Title
Crowdsourcing to Promote HBV and HCV Testing in China
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
June 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Doris Duke Charitable Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Hepatitis B, Hepatitis C
Keywords
Hepatitis, Hepatitis B, Hepatitis C, Men who have sex with men, Crowdsourcing, China, Testing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned in a 1:1 ratio to the study intervention or control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crowdsourced intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
No images or videos will be viewed, and suggestions for improving hepatitis testing materials will not be collected.
Intervention Type
Behavioral
Intervention Name(s)
Crowdsourced materials
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants will not view any images or videos promoting HBV and HCV testing.
Primary Outcome Measure Information:
Title
Confirmed HBV and HCV test uptake
Description
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
Time Frame
enrollment - 4 weeks after enrollment
Secondary Outcome Measure Information:
Title
Confirmed HBV test uptake
Description
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
Time Frame
enrollment - 4 weeks after enrollment
Title
Confirmed HCV test uptake
Description
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
Time Frame
enrollment - 4 weeks after enrollment
Title
Self-reported HBV test uptake
Description
Defined as frequency of men who had HBsAg uptake within four weeks of enrollment, self-reported in follow-up survey
Time Frame
enrollment - 4 weeks after enrollment
Title
Self-reported HCV test uptake
Description
Defined as frequency of men who had anti-HCV IgG uptake within four weeks of enrollment, self-reported in follow-up survey
Time Frame
enrollment - 4 weeks after enrollment
Title
HBV vaccination uptake
Description
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
Time Frame
enrollment - 4 weeks after enrollment
Title
HBV vaccination uptake among men with confirmed susceptibility to HBV infection
Description
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
Time Frame
enrollment - 4 weeks after enrollment
Title
HIV test uptake
Description
Defined as frequency of men who had HIV test uptake within four weeks of enrollment, self-reported in follow-up survey
Time Frame
enrollment - 4 weeks after enrollment
Title
Chlamydia test uptake
Description
Defined as frequency of men who had chlamydia test uptake within four weeks of enrollment, self-reported in follow-up survey
Time Frame
baseline - 4 weeks after enrollment
Title
Gonorrhea test uptake
Description
Defined as frequency of men who had gonorrhea test uptake within four weeks of enrollment, self-reported in follow-up survey
Time Frame
enrollment - 4 weeks after enrollment
Title
Syphilis test uptake
Description
Defined as frequency of men who had syphilis test uptake within four weeks of enrollment, self-reported in follow-up survey
Time Frame
enrollment - 4 weeks after enrollment
Title
Change in stigma toward people living with HBV
Description
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.
Time Frame
enrollment - 4 weeks after enrollment
Title
Visit with a physician after hepatitis test uptake
Description
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
Time Frame
enrollment - 4 weeks after enrollment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Tucker, MD, PhD, MA
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas Fitzpatrick
Organizational Affiliation
Institute for Global Health and Infectious Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Project-China
City
Guangzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All de-identified data generated or analyzed during this study will be included in published articles and supplementary information files.
IPD Sharing Time Frame
They will be shared upon publication of the main manuscript.
Citations:
PubMed Identifier
32779730
Citation
Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
Results Reference
derived
PubMed Identifier
30268114
Citation
Fitzpatrick T, Zhou K, Cheng Y, Chan PL, Cui F, Tang W, Mollan KR, Guo W, Tucker JD. A crowdsourced intervention to promote hepatitis B and C testing among men who have sex with men in China: study protocol for a nationwide online randomized controlled trial. BMC Infect Dis. 2018 Sep 29;18(1):489. doi: 10.1186/s12879-018-3403-3.
Results Reference
derived

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Crowdsourcing to Promote HBV and HCV Testing in China

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