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Completed

NCT Number: NCT02516930

A Non-inferiority 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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UNC Project-China

Guangzhou, Guangdong, 510095, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crowdsourced Video

Behavioral

video promoting condom use

social marketing video

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2015
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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