Crowdsourcing A Public Health Campaign

• ClinicalTrials.gov Identifier: NCT02796963
• Recruitment Status: Completed
• First Posted: June 13, 2016
• Results First Posted: May 11, 2018
• Last Update Posted: August 28, 2019
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); UNC-South China STD Research Training Center; UNC Center for AIDS Research; SESH Global; Guangdong Provincial Center for Skin Diseases and STI Control; London School of Hygiene and Tropical Medicine; University of Bristol; Shandong University; Shandong Province Centers for Disease Control and Prevention; Guangdong Center for Disease Prevention and Control
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV	Behavioral: Crowdsourced intervention; Behavioral: Traditional intervention campaign	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1381 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: 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
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: August 2017
• Actual Study Completion Date: August 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Immediate Intervention; Men will be exposed immediately to a comprehensive intervention promoting HIV testing.	Behavioral: Crowdsourced intervention; 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.	Behavioral: Crowdsourced intervention; 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.; Behavioral: Traditional intervention campaign; 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 Name: Conventional HIV testing campaign

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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 ]
2. 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
3. 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
4. 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.
5. 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 ]
6. 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 ]
7. 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.
8. 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 ]
9. 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 ]
10. 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 ]
11. 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 ]
12. 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
13. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Allergy and Infectious Diseases (NIAID)

UNC-South China STD Research Training Center

UNC Center for AIDS Research

SESH Global

Guangdong Provincial Center for Skin Diseases and STI Control

London School of Hygiene and Tropical Medicine

University of Bristol

Shandong University

Shandong Province Centers for Disease Control and Prevention

Guangdong Center for Disease Prevention and Control

Investigators

• Principal Investigator: Joseph D Tucker, MD, PhD; jdtucker@med.unc.edu

  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2017

More Information

Additional Information:

University of North Carolina website 

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02796963
• Other Study ID Numbers: 16-0851; R01AI114310 ( U.S. NIH Grant/Contract )
• First Posted: June 13, 2016
• Results First Posted: May 11, 2018
• Last Update Posted: August 28, 2019
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by University of North Carolina, Chapel Hill:

HIV; MSM; test uptake; crowdsourcing