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Completed

NCT Number: NCT03482388

Crowdsourcing to Promote HBV and HCV Testing in China

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.

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Key information

Conditions

Hepatitis Behavior Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Flaviviridae Infections Hepadnaviridae Infections Hepatitis B Hepatitis C Hepatitis, Viral, Human Homosexuality Infections Liver Diseases RNA Virus Infections Sexual Behavior Sexuality Virus Diseases

Age range

16 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UNC Project-China

Guangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crowdsourced materials

Behavioral

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

Other

Participants will not view any images or videos promoting HBV and HCV testing.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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