Crowdsourcing to Promote HBV and HCV Testing in China

NCT ID: NCT03482388

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2018-06-09

Brief Summary

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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

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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.

Conditions

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Hepatitis Hepatitis B Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned in a 1:1 ratio to the study intervention or control
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Crowdsourced materials

Intervention Type 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

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

Group Type OTHER

Control

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

Control

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Doris Duke Charitable Foundation

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Tucker, MD, PhD, MA

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Thomas Fitzpatrick

Role: PRINCIPAL_INVESTIGATOR

Institute for Global Health and Infectious Diseases

Locations

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UNC Project-China

Guangzhou, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 32779730 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30268114 (View on PubMed)

Other Identifiers

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18-0251

Identifier Type: -

Identifier Source: org_study_id

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