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

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ClinicalTrials.gov Identifier: NCT02516930
Recruitment Status : Completed
First Posted : August 6, 2015
Last Update Posted : April 7, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
SESH Global
Guangdong Provincial Center for Dermatology and STD Control
Shandong University
Shandong Province Centers for Disease Control and Prevention
University of California, San Francisco
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Joseph Tucker, MD, PhD, MA, University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Sexually Transmitted Diseases Behavioral: crowdsourced video Behavioral: social marketing video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516930


Locations
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China, Guangdong
UNC Project-China
Guangzhou, Guangdong, China, 510095
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
SESH Global
Guangdong Provincial Center for Dermatology and STD Control
Shandong University
Shandong Province Centers for Disease Control and Prevention
University of California, San Francisco
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Joseph D Tucker, MD, PhD, MA University of North Carolina

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joseph Tucker, MD, PhD, MA, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02516930     History of Changes
Other Study ID Numbers: 15-1522
1R01AI114310-01 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016

Keywords provided by Joseph Tucker, MD, PhD, MA, University of North Carolina, Chapel Hill:
health promotion
crowdsourcing

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Sexually Transmitted Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female