- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02796963
Crowdsourcing A Public Health Campaign
August 15, 2019 updated by: University of North Carolina, Chapel Hill
Institute for Global Health & Infectious Diseases (IGHID) 11604 - Crowdsourcing to Promote HIV Testing: A Stepped Wedge Randomized Controlled Trial to Evaluate Promoting HIV Testing in China
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will use an adaptation of the stepped wedge randomized controlled trial design.
A total of eight major metropolitan cities will implement the crowdsourced intervention.
These cities will be chosen based on the following criteria: 1) previous Centers for Disease Control and Prevention (CDC) MSM sentinel surveillance site; 2) capacity for campaign implementation; 3) capacity for intervention implementation at the community level.
Four cities will implement more intensive in-person events to promote engagement (Guangzhou, Shenzhen in Guangdong Province, Qingdao, and Jinan in Shandong Province) during survey intervention stage.
The Randomized controlled trial (RCT) will be evaluated using two different sources of data: 1) online survey data from MSM in the eight cities prior to and after the intervention; 2) CDC routine surveillance data in the eight cities prior to and after the intervention.
Study Type
Interventional
Enrollment (Actual)
1381
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
- 16 years or older
- Willing to provide cell phone number
- Complete the informed consent document
Exclusion Criteria:
- Women are excluded from this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Intervention
Men will be exposed immediately to a comprehensive intervention promoting HIV testing.
|
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.
|
Experimental: Delayed Intervention
Men will be exposed to a comprehensive intervention promoting HIV testing after a delay period.
|
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.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Men Reporting Condomless Sex at 3 Months Post-intervention
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
|
HIV Testing Social Norms
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
HIV testing social norms will be measured using six survey items that are each on a five-point Likert scale.
Increased HIV testing social norms will be defined as having an increase from baseline in any two of these six survey items and dichotomized accordingly.
Number of men who report higher score of social norms when comparing their pre-intervention and post-intervention values
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
Change in HIV Testing Self-efficacy
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
Number of men who report higher levels of self-efficacy when comparing their pre-intervention and post-intervention HIV testing norms
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
Community Engagement/ MSM Community Affiliation
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
Number of men, defined as an increase in closer affiliation with the MSM community (i.e., tongzhi circle, gay online networks or groups) when comparing their pre-intervention and post-intervention periods.
|
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
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
|
Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
|
Mean Score of Anticipated HIV Stigma
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
Measured by a 7-item version of the anticipated HIV stigma scale, designed to measure the extent to which participants anticipated negative intrapersonal and interpersonal consequences were they to contract HIV in the future.
All seven items were rated on a Likert-type scale (1=Strongly Disagree; 4=Strongly Agree).
The mean score is reported, ranged from 1 to 4. Higher values indicate greater anticipated stigma.
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
|
Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
|
Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
|
Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
|
Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
Frequency of men, defined as the number of men who reported using mobile apps in the past three months to give or receive information about HIV testing comparing their pre-intervention and post-intervention engagement
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
|
From implementation roll-out to three months after implementation of crowdsourced intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joseph D Tucker, MD, PhD, jdtucker@med.unc.edu
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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. Erratum In: Trials. 2017 Oct 23;18(1):495.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
May 23, 2016
First Submitted That Met QC Criteria
June 7, 2016
First Posted (Estimate)
June 13, 2016
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 15, 2019
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16-0851
- R01AI114310 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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