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HepatitisNCT03482388

Crowdsourcing to Promote HBV and HCV Testing in China

A study testing Crowdsourced materials in people with Hepatitis and Hepatitis B, run by University of North Carolina, Chapel Hill at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Hepatitis, Hepatitis B, Hepatitis C
What is being tested?
Crowdsourced materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
1 siteChina
Study dates
9 May 2018to 9 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • previous HBV vaccination
  • previous HBV testing
  • previous HCV testing

Trial locations and contacts

1 site in 1 country.

China1 site

  • UNC Project-China

    Guangzhou

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Crowdsourced materials, Control
Keywords
Hepatitis, Hepatitis B, Hepatitis C, Men who have sex with men, Crowdsourcing, China, Testing
Medical subject headings
Hepatitis, Hepatitis B, Hepatitis C, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crowdsourced materialsBehavioural

    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.

  • ControlOther

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

Study groups in NCT03482388
Study groupRoleWhat they receive
Crowdsourced interventionExperimentalA 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.
Receives: Behavioral: Crowdsourced materials
ControlOtherNo images or videos will be viewed, and suggestions for improving hepatitis testing materials will not be collected.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: enrollment - 4 weeks after enrollment

Secondary outcomes (12)

  1. 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

    Measured: enrollment - 4 weeks after enrollment

  2. 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

    Measured: enrollment - 4 weeks after enrollment

  3. 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

    Measured: enrollment - 4 weeks after enrollment

  4. 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

    Measured: enrollment - 4 weeks after enrollment

  5. 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

    Measured: enrollment - 4 weeks after enrollment

  6. 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

    Measured: enrollment - 4 weeks after enrollment

  7. HIV test uptake

    Defined as frequency of men who had HIV test uptake within four weeks of enrollment, self-reported in follow-up survey

    Measured: enrollment - 4 weeks after enrollment

  8. Chlamydia test uptake

    Defined as frequency of men who had chlamydia test uptake within four weeks of enrollment, self-reported in follow-up survey

    Measured: baseline - 4 weeks after enrollment

  9. Gonorrhea test uptake

    Defined as frequency of men who had gonorrhea test uptake within four weeks of enrollment, self-reported in follow-up survey

    Measured: enrollment - 4 weeks after enrollment

  10. Syphilis test uptake

    Defined as frequency of men who had syphilis test uptake within four weeks of enrollment, self-reported in follow-up survey

    Measured: enrollment - 4 weeks after enrollment

  11. 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.

    Measured: enrollment - 4 weeks after enrollment

  12. 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

    Measured: enrollment - 4 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start9 May 2018
  3. Primary completion15 May 2018
  4. Study completion9 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to the study intervention or control
Masking
None (open label)
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03482388
Sponsor's protocol ID
18-0251
Status last verified
Jun 2018
First submitted
22 Mar 2018
Last updated
20 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All de-identified data generated or analyzed during this study will be included in published articles and supplementary information files.

Publications

  • 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.

    PubMed 32779730

  • 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.

    PubMed 30268114

Questions about this trial

What is this clinical trial studying?

A study testing Crowdsourced materials in people with Hepatitis and Hepatitis B, run by University of North Carolina, Chapel Hill at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed HBV and HCV test uptake (time frame: enrollment - 4 weeks after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03482388, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.

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