Spurring Innovation to Promote HIV Testing: An RCT Evaluating Crowdsourcing

• 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: University of North Carolina, Chapel Hill
• 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: September 17, 2014
• First Posted Date: September 25, 2014
• Results First Submitted Date: October 26, 2016
• Results First Posted Date: December 20, 2016
• Last Update Posted Date: February 10, 2017
• Study Start Date: September 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Spurring Innovation to Promote HIV Testing: An RCT Evaluating Crowdsourcing
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Screening
• Condition: HIV

Intervention

• 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

• 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 *

• Wang C, Mollan KR, Hudgens MG, Tucker JD, Zheng H, Tang W, Ling L. Generalisability of an online randomised controlled trial: an empirical analysis. J Epidemiol Community Health. 2018 Feb;72(2):173-178. doi: 10.1136/jech-2017-209976. Epub 2017 Nov 28.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 5, 2014): 721
• Original Estimated Enrollment (submitted: September 22, 2014): 800
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02248558
• Other Study ID Numbers: 14-1865
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Joseph Tucker, MD, PhD, MA, University of North Carolina, Chapel Hill
• Study Sponsor: University of North Carolina, Chapel Hill

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

Investigators

• Principal Investigator: Joseph Tucker; UNC Project-China

• PRS Account: University of North Carolina, Chapel Hill
• Verification Date: December 2016