Utility of a US Food and Drug Administration (FDA) label indication for condoms for anal sex
Aaron J. Siegler A G , Lauren Ahlschlager A , Elizabeth M. Rosenthal
B C , Patrick S. Sullivan B , Colleen F. Kelley D , Eli S. Rosenberg B C , Travis H. Sanchez B , Reneé H. Moore E , C. Christina Mehta E and Michael P. Cecil F
A Department of Behavioral Science and Health Education, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
B Department of Epidemiology, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
C Department of Epidemiology and Biostatistics, University at Albany School of Public Health, SUNY One University Place, Rensselaer, NY 12144, USA.
D Emory University School of Medicine, 1648 Pierce Drive NE, Atlanta, GA 30307, USA.
E Department of Biostatistics and Bioinformatics, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
F TheyFit, LLC, 4140 Tate Street NE, Covington, GA 30014, USA.
G Corresponding author. Email: asiegle@emory.edu
Sexual Health 17(1) 91-95 https://doi.org/10.1071/SH18152
Submitted: 17 August 2018 Accepted: 27 June 2019 Published: 15 October 2019
Journal Compilation © CSIRO 2020 Open Access CC BY-NC-ND
Abstract
Condoms are highly effective for HIV prevention, yet are not currently indicated by the US Food and Drug Administration (FDA) for anal sex. We surveyed a national sample of men who have sex with men to assess whether FDA label indication could affect anticipated condom use, and to determine levels of perceived condom failure for anal sex. We found that 69% of respondents anticipated that a label indication change would increase their likelihood of condom use. Median perceived failure was 15%. We anticipate that these results may aid the FDA in developing standards for a label indication for anal sex.
Additional keywords: HIV, prevention, sexual and gender minorities.
References
[1] Centers for Disease Control and Prevention. HIV surveillance report. Volume 27. Diagnoses of HIV infection in the United States and dependent areas, 2015. 2016. Available online at: https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf [verified 6 September 2019].[2] Centers for Disease Control and Prevention. CDC fact sheet: what gay, bisexual and other men who have sex with men need to know about sexually transmitted diseases. 2017. Available online at: https://www.cdc.gov/std/life-stages-populations/stdfact-msm.htm [verified 24 January 2018].
[3] World Health Organization. Prevention and treatment of HIV and other sexually transmitted infections among men who have sex with men and transgender people: recommendations for a public health approach 2011. 2011. Available online at: http://www.who.int/hiv/pub/guidelines/msm_guidelines2011/en/ [verified 6 September 2019].
[4] U. S. Food and Drug Administration. Condoms and sexually transmitted diseases. 2016. Available online at: https://www.fda.gov/forpatients/illness/hivaids/prevention/ucm126372.htm [verified 22 December 2017].
[5] U.S. Food and Drug Administration (FDA). Testing guidance for male condoms made from new material (non-latex). 1995. Available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-guidance-male-condoms-made-new-material-non-latex [verified 6 September 2019].
[6] Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. 2009. Available online at: https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf [verified 6 September 2019].
[7] Zlotorzynska M, Sullivan P, Sanchez T. The annual American Men’s Internet Survey of behaviors of men who have sex with men in the United States: 2015 key indicators report. JMIR Public Health Surveill 2017; 3 e13
| The annual American Men’s Internet Survey of behaviors of men who have sex with men in the United States: 2015 key indicators report.Crossref | GoogleScholarGoogle Scholar | 28356240PubMed |
[8] Hernández-Romieu AC, Siegler AJ, Sullivan PS, Crosby R, Rosenberg ES. How often do condoms fail? A cross-sectional study exploring incomplete use of condoms, condom failures and other condom problems among black and white MSM in southern U.S.A. Sex Transm Infect 2014; 90 602–7.
| How often do condoms fail? A cross-sectional study exploring incomplete use of condoms, condom failures and other condom problems among black and white MSM in southern U.S.A.Crossref | GoogleScholarGoogle Scholar | 25080511PubMed |
[9] Siegler AJ, Voux A, Phaswana-Mafuya N, Bekker LG, Sullivan PS, Baral SD, et al Elements of condom-use decision making among South African men who have sex with men. J Int Assoc Provid AIDS Care 2014; 13 414–23.
| Elements of condom-use decision making among South African men who have sex with men.Crossref | GoogleScholarGoogle Scholar | 24935692PubMed |
[10] Rasberry CN, Condron DS, Lesesne CA, Adkins SH, Sheremenko G, Kroupa E. Associations between sexual risk-related behaviors and school-based education on HIV and condom use for adolescent sexual minority males and their non-sexual-minority peers. LGBT Health 2018; 5 69–77.
| Associations between sexual risk-related behaviors and school-based education on HIV and condom use for adolescent sexual minority males and their non-sexual-minority peers.Crossref | GoogleScholarGoogle Scholar | 29240528PubMed |
[11] Oldenburg CE, Perez-Brumer AG, Hatzenbuehler ML, Krakower D, Novak DS, Mimiaga MJ, et al State-level structural sexual stigma and HIV prevention in a national online sample of HIV-uninfected MSM in the United States. AIDS 2015; 29 837–45.
| State-level structural sexual stigma and HIV prevention in a national online sample of HIV-uninfected MSM in the United States.Crossref | GoogleScholarGoogle Scholar | 25730508PubMed |
[12] Beyrer C, Baral SD, van Griensven F, Goodreau SM, Chariyalertsak S, Wirtz AL, et al Global epidemiology of HIV infection in men who have sex with men. Lancet 2012; 380 367–77.
| Global epidemiology of HIV infection in men who have sex with men.Crossref | GoogleScholarGoogle Scholar | 22819660PubMed |
[13] U.S. Food and Drug Administration Center for Devices and Radiological Health. Letter from the Food and Drug Administration to Penny Northcutt: TheyFit Male Condom 510(k), Approval No. K150072. 2015. Available online at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150072.pdf [verified 6 September 2019].
