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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Human Immunodeficiency Virus, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: crowdsourced video
* Behavioral: social marketing video


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of condomless sex following the assigned video intervention (3 wk) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health promotion, crowdsourcing