Clinical trial NCT02516930: A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Sexually Transmitted Diseases
Keywords: health promotion
crowdsourcing
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: SESH Global
name: Guangdong Provincial Center for Dermatology and STD Control
name: Shandong University
name: Shandong Province Centers for Disease Control and Prevention
name: University of California, San Francisco
name: London School of Hygiene and Tropical Medicine
First posted: 2015-08-06
Enrollment: 1173
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Frequency of condomless sex following the assigned video intervention (3 wk)
timeFrame: 3 weeks following the video
measure: Frequency of condomless sex following the assigned video intervention (3 month)
timeFrame: 3 months following the video
Secondary outcomes:
measure: Incremental cost
timeFrame: 3 weeks after baseline
measure: Female condomless sex
timeFrame: 3 weeks and 3 months after baseline
measure: Male condomless sex
timeFrame: 3 weeks and 3 months after baseline
measure: Post-video condomless sex
timeFrame: 3 weeks after baseline
measure: Frequency of sex acts
timeFrame: 3 weeks and 3 months after baseline
measure: Condom self-efficacy
timeFrame: 3 weeks and 3 months after baseline
measure: Condom use social norms
timeFrame: 3 weeks and 3 months after baseline
measure: Condom use negotiation
timeFrame: 3 weeks and 3 months after baseline
measure: HIV testing
timeFrame: 3 weeks and 3 months after baseline
measure: STI testing
timeFrame: 3 weeks and 3 months after baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: UNC Project-China
state: Guangdong
Study officials:
affiliation: University of North Carolina
name: Joseph D Tucker, MD, PhD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Best 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.
citation: Bien 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.
citation: Wei 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.
citation: Bien 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.
citation: Han 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.
citation: Tucker 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.
citation: Tucker 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.
citation: Davis 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.
citation: Wang 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.
citation: Liu 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.