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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02516930
Enrollment
1173
Registered
2015-08-06
Start date
2015-09-30
Completion date
2016-02-29
Last updated
2016-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus, Sexually Transmitted Diseases

Keywords

health promotion, crowdsourcing

Brief summary

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.

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.

Interventions

video promoting condom use

BEHAVIORALsocial marketing video

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
SESH Global
CollaboratorUNKNOWN
Guangdong Provincial Center for Dermatology and STD Control
CollaboratorUNKNOWN
Shandong University
CollaboratorOTHER
Shandong Province Centers for Disease Control and Prevention
CollaboratorOTHER
University of California, San Francisco
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
CollaboratorOTHER
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of condomless sex following the assigned video intervention (3 wk)3 weeks following the videoFrequency 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
Frequency of condomless sex following the assigned video intervention (3 month)3 months following the videoFrequency 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

Secondary

MeasureTime frameDescription
Male condomless sex3 weeks and 3 months after baselineFrequency 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.
Post-video condomless sex3 weeks after baselineFrequency 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
Frequency of sex acts3 weeks and 3 months after baselineFrequency 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
Condom self-efficacy3 weeks and 3 months after baselineFrequency 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
Incremental cost3 weeks after baselineIncremental 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.
Condom use negotiation3 weeks and 3 months after baselineFrequency 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
HIV testing3 weeks and 3 months after baselineFrequency 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
STI testing3 weeks and 3 months after baselineFrequency 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
Condom use social norms3 weeks and 3 months after baselineFrequency 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.
Female condomless sex3 weeks and 3 months after baselineFrequency 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026