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Spurring Innovation to Promote HIV Testing: An RCT Evaluating Crowdsourcing

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ClinicalTrials.gov Identifier: NCT02248558
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : December 20, 2016
Last Update Posted : February 10, 2017
Sponsor:
Collaborators:
Social Entrepreneurship for Sexual Health (SESH)
University of California, San Francisco
London School of Hygiene and Tropical Medicine
Guangdong Provincial Centers for Skin Diseases and STI Control
Information provided by (Responsible Party):
Joseph Tucker, MD, PhD, MA, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE September 17, 2014
First Posted Date  ICMJE September 25, 2014
Results First Submitted Date  ICMJE October 26, 2016
Results First Posted Date  ICMJE December 20, 2016
Last Update Posted Date February 10, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
First-Time HIV Testing [ Time Frame: Up to 4 weeks following the video intervention ]
All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
  • Likelihood of HIV Testing [ Time Frame: Up to one day ]
    All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be "very unlikely", 1 will be "unlikely", 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported.
  • Cost-effectiveness of Developing HIV Testing Promotional Videos [ Time Frame: Up to one year ]
    Cost-effectiveness of developing the crowdsourced video compared to the conventional video
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spurring Innovation to Promote HIV Testing: An RCT Evaluating Crowdsourcing
Official Title  ICMJE Crowdsourcing Versus Conventional HIV Testing Promotion: A Noninferiority Randomized Controlled Trial to Evaluate Promoting First-Time HIV Testing Among MSM and Transgender Individuals in China
Brief Summary Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote HIV testing among key populations such as men who have sex with men (MSM) and transgender (TG) individuals. The purpose of this randomized controlled trial is to compare the effect of a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG in China. The crowdsourced video was developed using an open contest, formal transparent judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced video will be equivalent (within a margin of 3%) to a conventional video in terms of self-reported first-time HIV testing within 3-4 weeks of watching the video.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE HIV
Intervention  ICMJE
  • Behavioral: Conventional Video
    Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.
  • Behavioral: Crowdsourced Video
    Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.
Study Arms  ICMJE
  • Active Comparator: Conventional video
    This arm will receive a one-minute conventional video promoting HIV test uptake.
    Intervention: Behavioral: Conventional Video
  • Experimental: Crowdsourced video
    This arm will receive a one-minute crowdsourced video promoting HIV test uptake.
    Intervention: Behavioral: Crowdsourced Video
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2014)
721
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2014)
800
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Born biologically male or identify as transgender
  • 16 years or older
  • Lifetime anal sex with another man
  • Providing informed consent and active mobile phone number

Exclusion Criteria:

  • HIV-infected
  • HIV-tested ever in the past
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02248558
Other Study ID Numbers  ICMJE 14-1865
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Tucker, MD, PhD, MA, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Social Entrepreneurship for Sexual Health (SESH)
  • University of California, San Francisco
  • London School of Hygiene and Tropical Medicine
  • Guangdong Provincial Centers for Skin Diseases and STI Control
Investigators  ICMJE
Principal Investigator: Joseph Tucker UNC Project-China
PRS Account University of North Carolina, Chapel Hill
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP