NCT02796963

Brief Summary

The purpose of this stepped wedge randomized controlled trial is to evaluate the effectiveness of a crowdsourced intervention on promoting HIV testing among young Chinese men who have sex with men (MSM). The crowdsourced intervention will include an open contest, judging to determine finalists and prizes, a designathon, and contest-based MSM engagement. The hypothesis is that a crowdsourced intervention will be superior to conventional HIV test uptake campaigns in eliciting HIV test uptake.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,381

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable hiv

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

May 23, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 11, 2018

Completed
Last Updated

August 28, 2019

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

May 23, 2016

Results QC Date

February 22, 2018

Last Update Submit

August 15, 2019

Conditions

HIV

Keywords

HIVMSMtest uptakecrowdsourcing

Outcome Measures

Primary Outcomes (1)

  • Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months

    This will be assessed by self-report during a follow-up survey

    From implementation roll-out to three months after implementation of crowdsourced intervention

Secondary Outcomes (13)

  • Number of Men Reporting Condomless Sex at 3 Months Post-intervention

    From implementation roll-out to three months after implementation of crowdsourced intervention

  • HIV Testing Social Norms

    From implementation roll-out to three months after implementation of crowdsourced intervention

  • Change in HIV Testing Self-efficacy

    From implementation roll-out to three months after implementation of crowdsourced intervention

  • Community Engagement/ MSM Community Affiliation

    From implementation roll-out to three months after implementation of crowdsourced intervention

  • Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months

    From implementation roll-out to three months after implementation of crowdsourced intervention

  • +8 more secondary outcomes

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Men will be exposed immediately to a comprehensive intervention promoting HIV testing.

Behavioral: Crowdsourced intervention

Delayed Intervention

EXPERIMENTAL

Men will be exposed to a comprehensive intervention promoting HIV testing after a delay period.

Behavioral: Crowdsourced interventionBehavioral: Traditional intervention campaign

Interventions

Crowdsourced interventionBEHAVIORAL

The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.

Delayed InterventionImmediate Intervention
Traditional intervention campaignBEHAVIORAL

The pre-intervention period will include conventional HIV testing campaigns organized by local CDC, Community-Based Organization (CBO), and partners. These are typically designed by experts and social marketing companies.

Also known as: Conventional HIV testing campaign
Delayed Intervention

Eligibility Criteria

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

You may qualify if:

  • Currently living and planning to live in one of the eight cities used in the study in the next 12 months.
  • Not living with HIV
  • No HIV test in the past three months
  • Born biologically male and identify as either male or transgender female
  • Had anal or oral sex with men at least once during their lifetime
  • years or older
  • Willing to provide cell phone number
  • Complete the informed consent document

You may not qualify if:

  • Women are excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Tang W, Han L, Best J, Zhang Y, Mollan K, Kim J, Liu F, Hudgens M, Bayus B, Terris-Prestholt F, Galler S, Yang L, Peeling R, Volberding P, Ma B, Xu H, Yang B, Huang S, Fenton K, Wei C, Tucker JD. Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China. Clin Infect Dis. 2016 Jun 1;62(11):1436-1442. doi: 10.1093/cid/ciw171. Epub 2016 Apr 29.

    PMID: 27129465BACKGROUND

  • Zhang Y, Kim JA, Liu F, Tso LS, Tang W, Wei C, Bayus BL, Tucker JD. Creative Contributory Contests to Spur Innovation in Sexual Health: 2 Cases and a Guide for Implementation. Sex Transm Dis. 2015 Nov;42(11):625-8. doi: 10.1097/OLQ.0000000000000349.

    PMID: 26462186BACKGROUND

  • Ong JJ, Booton RD, Tucker JD, Tang W, Vickerman P, Zhang L, Mitchell KM. Economic evaluation of improving HIV self-testing among MSM in China using a crowdsourced intervention: a cost-effectiveness analysis. AIDS. 2023 Mar 15;37(4):671-678. doi: 10.1097/QAD.0000000000003457. Epub 2022 Dec 9.

    PMID: 36729711DERIVED

  • Tang W, Wei C, Cao B, Wu D, Li KT, Lu H, Ma W, Kang D, Li H, Liao M, Mollan KR, Hudgens MG, Liu C, Huang W, Liu A, Zhang Y, Smith MK, Mitchell KM, Ong JJ, Fu H, Vickerman P, Yang L, Wang C, Zheng H, Yang B, Tucker JD. Crowdsourcing to expand HIV testing among men who have sex with men in China: A closed cohort stepped wedge cluster randomized controlled trial. PLoS Med. 2018 Aug 28;15(8):e1002645. doi: 10.1371/journal.pmed.1002645. eCollection 2018 Aug.

    PMID: 30153265DERIVED

  • SESH Study Group; Tucker JD. Crowdsourcing to promote HIV testing among MSM in China: study protocol for a stepped wedge randomized controlled trial. Trials. 2017 Oct 2;18(1):447. doi: 10.1186/s13063-017-2183-1.

    PMID: 28969702DERIVED

Related Links

Results Point of Contact

Title
Dr. Weiming Tang
Organization
UNC Project-China
weimingtangscience@gmail.com
+86-21-83755824

Study Officials

  • Joseph D Tucker, MD, PhD

    jdtucker@med.unc.edu

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 13, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 28, 2019

Results First Posted

May 11, 2018

Record last verified: 2018-02