Clinical trial NCT02796963: Crowdsourcing A Public Health Campaign
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
MSM
test uptake
crowdsourcing
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: UNC-South China STD Research Training Center
name: UNC Center for AIDS Research
name: SESH Global
name: Guangdong Provincial Center for Skin Diseases and STI Control
name: London School of Hygiene and Tropical Medicine
name: University of Bristol
name: Shandong University
name: Shandong Province Centers for Disease Control and Prevention
name: Guangdong Center for Disease Prevention and Control
First posted: 2016-06-13
Enrollment: 1381
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
Secondary outcomes:
measure: Number of Men Reporting Condomless Sex at 3 Months Post-intervention
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: HIV Testing Social Norms
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Change in HIV Testing Self-efficacy
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Community Engagement/ MSM Community Affiliation
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Mean Score of Anticipated HIV Stigma
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
measure: Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention
timeFrame: From implementation roll-out to three months after implementation of crowdsourced intervention
Other outcomes:
Locations:
Study officials:
affiliation: jdtucker@med.unc.edu
name: Joseph D Tucker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.