NCT03482388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 9, 2018

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

6 days

First QC Date

March 22, 2018

Last Update Submit

June 18, 2018

Conditions

Keywords

HepatitisHepatitis BHepatitis CMen who have sex with menCrowdsourcingChinaTesting

Outcome Measures

Primary Outcomes (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

    enrollment - 4 weeks after enrollment

Secondary Outcomes (12)

  • Confirmed HBV test uptake

    enrollment - 4 weeks after enrollment

  • Confirmed HCV test uptake

    enrollment - 4 weeks after enrollment

  • Self-reported HBV test uptake

    enrollment - 4 weeks after enrollment

  • Self-reported HCV test uptake

    enrollment - 4 weeks after enrollment

  • HBV vaccination uptake

    enrollment - 4 weeks after enrollment

  • +7 more secondary outcomes

Study Arms (2)

Crowdsourced intervention

EXPERIMENTAL

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

Control

OTHER

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

Other: Control

Interventions

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.

Crowdsourced intervention
ControlOTHER

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

Control

Eligibility Criteria

Age16 Years+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Project-China

Guangzhou, China

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

HepatitisHepatitis BHepatitis CHomosexuality

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsRNA Virus InfectionsSexualitySexual BehaviorBehavior

Study Officials

  • Joseph Tucker, MD, PhD, MA

    University of North Carolina, Chapel Hill

    STUDY DIRECTOR
  • Thomas Fitzpatrick

    Institute for Global Health and Infectious Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to the study intervention or control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2018

First Posted

March 29, 2018

Study Start

May 9, 2018

Primary Completion

May 15, 2018

Study Completion

June 9, 2018

Last Updated

June 20, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

All de-identified data generated or analyzed during this study will be included in published articles and supplementary information files.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
They will be shared upon publication of the main manuscript.

Locations