A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China

April 6, 2016 updated by: Joseph Tucker, MD, PhD, MA, University of North Carolina, Chapel Hill

Crowdsourcing Versus Social Marketing Video Campaigns to Promote Condom Use: A Noninferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China

This is a pragmatic, non-inferiority, randomized controlled trial comparing the effectiveness of two methods (crowdsourcing versus social marketing) for creating one-minute videos promoting condom use among MSM and TG in China. Crowdsourcing is the process of shifting individual tasks to a large group, often involving open contests and enabled through multisectoral partnerships.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote condom use 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 social marketing video on condom use among Chinese MSM and TG who report condomless anal sex during the past three months. The crowdsourced video was developed using an open contest, formal transparent judging, and several prizes. The hypothesis is that a crowdsourced video will not be inferior (within a margin of 10%) to a social marketing video in terms of condomless sex at three to four weeks (with an additional follow-up at three months) of watching the video.

Study Type

Interventional

Enrollment (Actual)

1173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510095
        • UNC Project-China

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • The target population for the condom use substudy is males, 16 years of age or older, who were born biologically male or are transgender, have had condomless sex in the past three months and are willing to provide their cell mobile number.

Exclusion Criteria:

  • Females

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Crowdsourced video
One-minute crowd-sourced video promoting condom use among men who have sex with men and transgender individuals.
Behavioral: crowdsourced video
video promoting condom use
Other: Social marketing video
One-minute social marketing video promoting condom use among men who have sex with men and transgender individuals
Behavioral: social marketing video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of condomless sex following the assigned video intervention (3 wk)
Time Frame: 3 weeks following the video
Frequency of men, defined as those who report condomless sex over the 3 week period divided by the total number of men who watched the video
3 weeks following the video
Frequency of condomless sex following the assigned video intervention (3 month)
Time Frame: 3 months following the video
Frequency of men, defined as those who report condomless sex over the 3 month period divided by the total number of men who watched the video
3 months following the video

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental cost
Time Frame: 3 weeks after baseline
Incremental cost, defined as the cost associated with respective video interventions per individual who reported no sex or sex with a condom during the follow-up period.
3 weeks after baseline
Female condomless sex
Time Frame: 3 weeks and 3 months after baseline
Frequency of men, defined as number of men who reported condomless vaginal or anal sex with a woman divided by the total number of men who viewed the video in that arm.
3 weeks and 3 months after baseline
Male condomless sex
Time Frame: 3 weeks and 3 months after baseline
Frequency of men, defined as number of men who reported condomless anal sex with a man divided by the total number of men who viewed the video in that arm.
3 weeks and 3 months after baseline
Post-video condomless sex
Time Frame: 3 weeks after baseline
Frequency of men, defined as number of men who reported condomless vaginal or anal sex with any partner immediately following the video intervention divided by the total number of men who viewed the video in that arm
3 weeks after baseline
Frequency of sex acts
Time Frame: 3 weeks and 3 months after baseline
Frequency of men, defined as the number of men who had decreased total number of sex acts in the three weeks following the intervention compared to the three weeks immediately preceding the intervention in that arm
3 weeks and 3 months after baseline
Condom self-efficacy
Time Frame: 3 weeks and 3 months after baseline
Frequency of men, defined as number of men who had an increase in self-efficacy when comparing self-efficacy during the three weeks before baseline and the three weeks after the baseline, will measure again at 3 months and then compare baseline and three month data
3 weeks and 3 months after baseline
Condom use social norms
Time Frame: 3 weeks and 3 months after baseline
Frequency of men, defined as number of men who report higher levels of social norms when comparing their pre-intervention and post-intervention condom use norms.
3 weeks and 3 months after baseline
Condom use negotiation
Time Frame: 3 weeks and 3 months after baseline
Frequency of men, defined as the number of men who attempted to convince an unwilling partner to use a condom immediately following the video intervention divided by the total number of men who viewed the video in that arm
3 weeks and 3 months after baseline
HIV testing
Time Frame: 3 weeks and 3 months after baseline
Frequency of men, defined as the number of men who reported being tested for HIV during the interval between watching the video and following up compared to the number of men who followed up
3 weeks and 3 months after baseline
STI testing
Time Frame: 3 weeks and 3 months after baseline
Frequency of men, defined as the number of men who reported being tested for STIs (excluding HIV) during the interval between watching the video and following up compared to the number of men who followed up
3 weeks and 3 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

London School of Hygiene and Tropical Medicine
Shandong University
National Institutes of Health (NIH)
University of California, San Francisco
SESH Global
Shandong Province Centers for Disease Control and Prevention
Guangdong Provincial Center for Dermatology and STD Control

Investigators

  • Principal Investigator: Joseph D Tucker, MD, PhD, MA, University of North Carolina

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

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

September 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 25, 2015

First Submitted That Met QC Criteria

August 3, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-1522
  • 1R01AI114310-01 (U.S. NIH Grant/Contract)

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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