Crowdsourcing to Promote HBV and HCV Testing in China

June 18, 2018 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • UNC Project-China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
enrollment - 4 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
enrollment - 4 weeks after enrollment
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
enrollment - 4 weeks after enrollment
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
enrollment - 4 weeks after enrollment
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
enrollment - 4 weeks after enrollment
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
enrollment - 4 weeks after enrollment
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
enrollment - 4 weeks after enrollment
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
enrollment - 4 weeks after enrollment
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
baseline - 4 weeks after enrollment
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
enrollment - 4 weeks after enrollment
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
enrollment - 4 weeks after enrollment
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.
enrollment - 4 weeks after enrollment
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
enrollment - 4 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Doris Duke Charitable Foundation

Investigators

  • Study Director: Joseph Tucker, MD, PhD, MA, University of North Carolina, Chapel Hill
  • Principal Investigator: Thomas Fitzpatrick, Institute for Global Health and Infectious Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 9, 2018

Primary Completion (ACTUAL)

May 15, 2018

Study Completion (ACTUAL)

June 9, 2018

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (ACTUAL)

March 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-0251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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