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

Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516930
• Other study ID #: 15-1522
• Secondary ID: 1R01AI114310-01
• Status: Completed
• Phase: N/A
• First received: July 25, 2015
• Last updated: April 6, 2016
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Ethics Committee
• Study type: Interventional

Clinical 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. Crowdsourcing is the process of shifting individual tasks to a large group, often involving open contests and enabled through multisectoral partnerships.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1173
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Sexually Transmitted Diseases

Intervention

Behavioral:
• crowdsourced video
video promoting condom use
• social marketing video

Locations

Country	Name	City	State
China	UNC Project-China	Guangzhou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Guangdong Provincial Center for Dermatology and STD Control, London School of Hygiene and Tropical Medicine, National Institutes of Health (NIH), SESH Global, Shandong Provincial Centers for Disease Control and Prevention, Shandong University, University of California, San Francisco

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View 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. — View 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. — View 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. 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. 2015 Jul 15. pii: 0956462415596302. [Epub ahead of print] — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Social Entrepreneurship for Sexual Health Global
•   University of North Carolina website