Human Immunodeficiency VirusNCT02516930
A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China
A study testing crowdsourced video and social marketing video in people with Human Immunodeficiency Virus and Sexually Transmitted Diseases, run by University of North Carolina, Chapel Hill at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Sexually Transmitted Diseases
- What is being tested?
- crowdsourced video and social marketing video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,173 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Females
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- crowdsourced video, social marketing video
- Keywords
- health promotion, crowdsourcing
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crowdsourced videoBehavioural
video promoting condom use
social marketing videoBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Crowdsourced video | Other | One-minute crowd-sourced video promoting condom use among men who have sex with men and transgender individuals. Receives: Behavioral: crowdsourced video |
| Social marketing video | Other | One-minute social marketing video promoting condom use among men who have sex with men and transgender individuals Receives: Behavioral: social marketing video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months following the video
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 3 weeks and 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Joseph Tucker, MD, PhD, MA, University of North Carolina, Chapel Hill
- Investigators
- Joseph D Tucker, MD, PhD, MA, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516930
- Sponsor's protocol ID
- 15-1522
- Other IDs
- 1R01AI114310-01
- Status last verified
- Apr 2016
- First submitted
- 25 Jul 2015
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Muessig KE, Bien CH, Wei C, Lo EJ, Yang M, Tucker JD, Yang L, Meng G, Hightow-Weidman LB. A mixed-methods study on the acceptability of using eHealth for HIV prevention and sexual health care among men who have sex with men in China. J Med Internet Res. 2015 Apr 21;17(4):e100. doi: 10.2196/jmir.3370.
PubMed 25900881Best J, Tang W, Zhang Y, Han L, Liu F, Huang S, Yang B, Wei C, Tucker JD. Sexual behaviors and HIV/syphilis testing among transgender individuals in China: implications for expanding HIV testing services. Sex Transm Dis. 2015 May;42(5):281-5. doi: 10.1097/OLQ.0000000000000269.
PubMed 25868142Bien CH, Muessig KE, Lee R, Lo EJ, Yang LG, Yang B, Peeling RW, Tucker JD. HIV and syphilis testing preferences among men who have sex with men in South China: a qualitative analysis to inform sexual health services. PLoS One. 2015 Apr 13;10(4):e0124161. doi: 10.1371/journal.pone.0124161. eCollection 2015.
PubMed 25875336Wei C, Muessig KE, Bien C, Yang L, Meng R, Han L, Yang M, Tucker JD. Strategies for promoting HIV testing uptake: willingness to receive couple-based and collective HIV testing among a cross-sectional online sample of men who have sex with men in China. Sex Transm Infect. 2014 Sep;90(6):469-74. doi: 10.1136/sextrans-2013-051460. Epub 2014 Apr 23.
PubMed 24760266Bien CH, Best JM, Muessig KE, Wei C, Han L, Tucker JD. Gay Apps for Seeking Sex Partners in China: Implications for MSM Sexual Health. AIDS Behav. 2015 Jun;19(6):941-6. doi: 10.1007/s10461-014-0994-6.
PubMed 25572834Han L, Bien CH, Wei C, Muessig KE, Yang M, Liu F, Yang L, Meng G, Emch ME, Tucker JD. HIV self-testing among online MSM in China: implications for expanding HIV testing among key populations. J Acquir Immune Defic Syndr. 2014 Oct 1;67(2):216-21. doi: 10.1097/QAI.0000000000000278.
PubMed 24991972Tucker JD, Muessig KE, Cui R, Bien CH, Lo EJ, Lee R, Wang K, Han L, Liu FY, Yang LG, Yang B, Larson H, Peeling RW. Organizational characteristics of HIV/syphilis testing services for men who have sex with men in South China: a social entrepreneurship analysis and implications for creating sustainable service models. BMC Infect Dis. 2014 Nov 25;14:601. doi: 10.1186/s12879-014-0601-5.
PubMed 25422065Tucker JD, Wei C, Pendse R, Lo YR. HIV self-testing among key populations: an implementation science approach to evaluating self-testing. J Virus Erad. 2015 Jan;1(1):38-42. doi: 10.1016/S2055-6640(20)31145-6.
PubMed 26005717Davis A, Best J, Luo J, Van Der Pol B, Dodge B, Meyerson B, Aalsma M, Wei C, Tucker JD; Social Entrepreneurship for Sexual Health Research Group. Differences in risk behaviours, HIV/STI testing and HIV/STI prevalence between men who have sex with men and men who have sex with both men and women in China. Int J STD AIDS. 2016 Sep;27(10):840-9. doi: 10.1177/0956462415596302. Epub 2015 Jul 15.
PubMed 26185041Wang C, Tucker JD, Liu C, Zheng H, Tang W, Ling L. Condom use social norms and self-efficacy with different kinds of male partners among Chinese men who have sex with men: results from an online survey. BMC Public Health. 2018 Oct 16;18(1):1175. doi: 10.1186/s12889-018-6090-5.
PubMed 30326880Liu C, Mao J, Wong T, Tang W, Tso LS, Tang S, Zhang Y, Zhang W, Qin Y, Chen Z, Ma W, Kang D, Li H, Liao M, Mollan K, Hudgens M, Bayus B, Huang S, Yang B, Wei C, Tucker JD. Comparing the effectiveness of a crowdsourced video and a social marketing video in promoting condom use among Chinese men who have sex with men: a study protocol. BMJ Open. 2016 Oct 3;6(10):e010755. doi: 10.1136/bmjopen-2015-010755.
PubMed 27697868
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02516930
- Acronym / sponsor ID
- 15-1522
- Keywords
- health promotion, crowdsourcing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,173 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- 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
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crowdsourced video | Other | Behavioral: crowdsourced videoOne-minute crowd-sourced video promoting condom use among men who have sex with men and transgender individuals. |
| Social marketing video | Other | Behavioral: social marketing videoOne-minute social marketing video promoting condom use among men who have sex with men and transgender individuals |
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crowdsourced videovideo promoting condom use | Behavioural | Crowdsourced video |
| social marketing video | Behavioural | Social marketing video |
Primary outcome
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
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
10 secondary outcomes
Incremental cost
Time frame: 3 weeks after baseline
Female condomless sex
Time frame: 3 weeks and 3 months after baseline
Male condomless sex
Time frame: 3 weeks and 3 months after baseline
Post-video condomless sex
Time frame: 3 weeks after baseline
Frequency of sex acts
Time frame: 3 weeks and 3 months after baseline
Condom self-efficacy
Time frame: 3 weeks and 3 months after baseline
Condom use social norms
Time frame: 3 weeks and 3 months after baseline
Condom use negotiation
Time frame: 3 weeks and 3 months after baseline
HIV testing
Time frame: 3 weeks and 3 months after baseline
STI testing
Time frame: 3 weeks and 3 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Background: PubMed 25900881Muessig KE, Bien CH, Wei C, Lo EJ, Yang M, Tucker JD, Yang L, Meng G, Hightow-Weidman LB. A mixed-methods study on the acceptability of using eHealth for HIV prevention and sexual health care among men who have sex with men in China. J Med Internet Res. 2015 Apr 21;17(4):e100. doi: 10.2196/jmir.3370.
- Background: PubMed 25868142Best J, Tang W, Zhang Y, Han L, Liu F, Huang S, Yang B, Wei C, Tucker JD. Sexual behaviors and HIV/syphilis testing among transgender individuals in China: implications for expanding HIV testing services. Sex Transm Dis. 2015 May;42(5):281-5. doi: 10.1097/OLQ.0000000000000269.
- Background: PubMed 25875336Bien CH, Muessig KE, Lee R, Lo EJ, Yang LG, Yang B, Peeling RW, Tucker JD. HIV and syphilis testing preferences among men who have sex with men in South China: a qualitative analysis to inform sexual health services. PLoS One. 2015 Apr 13;10(4):e0124161. doi: 10.1371/journal.pone.0124161. eCollection 2015.
- Background: PubMed 24760266Wei C, Muessig KE, Bien C, Yang L, Meng R, Han L, Yang M, Tucker JD. Strategies for promoting HIV testing uptake: willingness to receive couple-based and collective HIV testing among a cross-sectional online sample of men who have sex with men in China. Sex Transm Infect. 2014 Sep;90(6):469-74. doi: 10.1136/sextrans-2013-051460. Epub 2014 Apr 23.
- Background: PubMed 25572834Bien CH, Best JM, Muessig KE, Wei C, Han L, Tucker JD. Gay Apps for Seeking Sex Partners in China: Implications for MSM Sexual Health. AIDS Behav. 2015 Jun;19(6):941-6. doi: 10.1007/s10461-014-0994-6.
- Background: PubMed 24991972Han L, Bien CH, Wei C, Muessig KE, Yang M, Liu F, Yang L, Meng G, Emch ME, Tucker JD. HIV self-testing among online MSM in China: implications for expanding HIV testing among key populations. J Acquir Immune Defic Syndr. 2014 Oct 1;67(2):216-21. doi: 10.1097/QAI.0000000000000278.
- Background: PubMed 25422065Tucker JD, Muessig KE, Cui R, Bien CH, Lo EJ, Lee R, Wang K, Han L, Liu FY, Yang LG, Yang B, Larson H, Peeling RW. Organizational characteristics of HIV/syphilis testing services for men who have sex with men in South China: a social entrepreneurship analysis and implications for creating sustainable service models. BMC Infect Dis. 2014 Nov 25;14:601. doi: 10.1186/s12879-014-0601-5.
- Background: PubMed 26005717Tucker JD, Wei C, Pendse R, Lo YR. HIV self-testing among key populations: an implementation science approach to evaluating self-testing. J Virus Erad. 2015 Jan;1(1):38-42. doi: 10.1016/S2055-6640(20)31145-6.
- Background: PubMed 26185041Davis A, Best J, Luo J, Van Der Pol B, Dodge B, Meyerson B, Aalsma M, Wei C, Tucker JD; Social Entrepreneurship for Sexual Health Research Group. Differences in risk behaviours, HIV/STI testing and HIV/STI prevalence between men who have sex with men and men who have sex with both men and women in China. Int J STD AIDS. 2016 Sep;27(10):840-9. doi: 10.1177/0956462415596302. Epub 2015 Jul 15.
- Derived from this study: PubMed 30326880Wang C, Tucker JD, Liu C, Zheng H, Tang W, Ling L. Condom use social norms and self-efficacy with different kinds of male partners among Chinese men who have sex with men: results from an online survey. BMC Public Health. 2018 Oct 16;18(1):1175. doi: 10.1186/s12889-018-6090-5.
- Derived from this study: PubMed 27697868Liu C, Mao J, Wong T, Tang W, Tso LS, Tang S, Zhang Y, Zhang W, Qin Y, Chen Z, Ma W, Kang D, Li H, Liao M, Mollan K, Hudgens M, Bayus B, Huang S, Yang B, Wei C, Tucker JD. Comparing the effectiveness of a crowdsourced video and a social marketing video in promoting condom use among Chinese men who have sex with men: a study protocol. BMJ Open. 2016 Oct 3;6(10):e010755. doi: 10.1136/bmjopen-2015-010755.
- Social Entrepreneurship for Sexual Health GlobalLink provided by the sponsor.
- University of North Carolina websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph D Tucker, MD, PhD, MA principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crowdsourced video and social marketing video in people with Human Immunodeficiency Virus and Sexually Transmitted Diseases, run by University of North Carolina, Chapel Hill at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of condomless sex following the assigned video intervention (3 wk) (time frame: 3 weeks following the video). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02516930, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.