Acceptability of Potential Rectal Microbicide Delivery Systems for HIV Prevention: A Randomized Crossover Trial
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
We assessed the acceptability of three of over-the-counter products representative of potential rectal microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who engage in receptive anal intercourse participated in a 6-week randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to identify underlying factors measured by each scale. Random effects models were fit to examine age and gender effects on product acceptability. Three underlying factors were identified: Satisfaction with Product Use, Sexual Pleasure, and Ease of Product Use. For acceptability, the applicator ranked highest; however, differences between product acceptability scores were greatest among females and younger participants. These findings indicate that RM delivery systems impact their acceptability and should be considered early in RM development to enhance potential use.
- Rosenberger JG, Reece M, Schick V, et al. Sexual behaviors and situational characteristics of most recent male-partnered sexual event among gay and bisexually identified men in the United States. J Sex Med. 2011;8(11):3040–50. CrossRef
- Reece M, Herbenick D, Schick V, Sanders SA, Dodge B, Fortenberry JD. Condom use rates in a national probability sample of males and females ages 14 to 94 in the United States. J Sex Med. 2010;7(Suppl 5):266–76. CrossRef
- Herbenick D, Reece M, Schick V, Sanders SA, Dodge B, Fortenberry JD. Sexual behavior in the United States: results from a national probability sample of men and women ages 14–94. J Sex Med. 2010;7(Suppl 5):255–65. CrossRef
- Vittinghoff E, Douglas J, Judson F, McKirnan D, MacQueen K, Buchbinder SP. Per-contact risk of human immunodeficiency virus transmission between male sexual partners. Am J Epidemiol. 1999;150(3):306–11. CrossRef
- Varghese B, Maher JE, Peterman TA, Branson BM, Steketee RW. Reducing the risk of sexual HIV transmission: quantifying the per-act risk for HIV on the basis of choice of partner, sex act, and condom use. Sex Transm Dis. 2002;29(1):38–43. CrossRef
- Mantell JE, Myer L, Carballo-Dieguez A, et al. Microbicide acceptability research: current approaches and future directions. Soc Sci Med. 2005;60(2):319–30. CrossRef
- Gross M, Celum CL, Tabet SR, Kelly CW, Coletti AS, Chesney MA. Acceptability of a bioadhesive nonoxynol-9 gel delivered by an applicator as a rectal microbicide. Sex Transm Dis. 1999;26(10):572–8. CrossRef
- Carballo-Dieguez A, Exner T, Dolezal C, Pickard R, Lin P, Mayer KH. Rectal microbicide acceptability: results of a volume escalation trial. Sex Transm Dis. 2007;34(4):224–9. CrossRef
- Ventuneac A, Carballo-Dieguez A, McGowan I, et al. Acceptability of UC781 gel as a rectal microbicide among HIV-uninfected women and men. AIDS Behav. 2010;14(3):618–28. CrossRef
- Anton PA, Cranston RD, Kashuba A, et al. RMP-02/MTN-006: a Phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1 % gel compared with oral tenofovir disoproxil fumarate. AIDS Res Hum Retroviruses. 2012. [Epub ahead of print].
- McGowan I, Hoesley C, Andrew P, et al. MTN-007: a Phase 1 randomized, double-blind, placebo-controlled rectal safety and acceptability study of tenofovir 1 % Gel. 19th conference on retroviruses and opportunistic infections. Seattle, 2012 [abstract 34LB].
- Carballo-Dieguez A, Dolezal C, Bauermeister JA, O’Brien W, Ventuneac A, Mayer K. Preference for gel over suppository as delivery vehicle for a rectal microbicide: results of a randomised, crossover acceptability trial among men who have sex with men. Sex Transm Infect. 2008;84(6):483–7. CrossRef
- Coly A, Gorbach PM. Microbicide acceptability research: recent findings and evolution across phases of product development. Curr Opin HIV AIDS. 2008;3(5):581–6. CrossRef
- Carballo-Dieguez A, Bauermeister J, Ventuneac A, Dolezal C, Mayer K. Why rectal douches may be acceptable rectal-microbicide delivery vehicles for men who have sex with men. Sex Transm Dis. 2009;37(4):228–33.
- Gross M, Buchbinder SP, Celum C, Heagerty P, Seage GR 3rd. Rectal microbicides for U.S. gay men. Are clinical trials needed? Are they feasible? HIVNET vaccine preparedness study protocol team. Sex Transm Dis. 1998;25(6):296–302. CrossRef
- Carballo-Dieguez A, Stein Z, Saez H, Dolezal C, Nieves-Rosa L, Diaz F. Frequent use of lubricants for anal sex among men who have sex with men: the HIV prevention potential of a microbicidal gel. Am J Public Health. 2000;90(7):1117–21. CrossRef
- Carballo-Dieguez A, O’Sullivan LF, Lin P, Dolezal C, Pollack L, Catania J. Awareness and attitudes regarding microbicides and Nonoxynol-9 use in a probability sample of gay men. AIDS Behav. 2007;11(2):271–6. CrossRef
- Javanbakht M, Murphy R, Gorbach P, LeBlanc MA, Pickett J. Preference and practices relating to lubricant use during anal intercourse: implications for rectal microbicides. Sex Health. 2010;7(2):193–8. CrossRef
- Gorbach PM, Weiss RE, Fuchs E, et al. The slippery slope: lubricant use and rectal sexually transmitted infections: a newly identified risk. Sex Transm Dis. 2012;39(1):59–64. CrossRef
- Stahlman S, Gorbach PM. Rectal behaviors: a global overview. Microbicides 2012. Sydney, 2012.
- Weiss RE. Modeling longitudinal data. New York: Springer; 2005.
- Martino JL, Vermund SH. Vaginal douching: evidence for risks or benefits to women’s health. Epidemiol Rev. 2002;24(2):109–24. CrossRef
- Gorbach P M, Borgerding JA, Coumi N, et al. Effects of Partnership Change on Gel Adherence in HPTN 035. Microbicides 2010. Pittsburgh, 2010.
- Acceptability of Potential Rectal Microbicide Delivery Systems for HIV Prevention: A Randomized Crossover Trial
AIDS and Behavior
Volume 17, Issue 3 , pp 1002-1015
- Cover Date
- Print ISSN
- Online ISSN
- Springer US
- Additional Links
- Anorectal products
- Receptive anal intercourse
- HIV prevention
- Industry Sectors
- Author Affiliations
- 1. Department of Epidemiology, Fielding School of Public Health, University of California-Los Angeles, 650 Charles E. Young Dr., South CHS 41-295A, P.O. Box 951772, Los Angeles, CA, 90095-1772, USA
- 2. Department of Biostatistics, Fielding School of Public Health, University of California-Los Angeles, Los Angeles, CA, USA
- 3. David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA
- 4. Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA