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. 2005 Jun;81(3):193–200. doi: 10.1136/sti.2003.007153

Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions

A Minnis 1, N Padian 1
PMCID: PMC1744969  PMID: 15923284

Abstract

Objectives: To evaluate evidence for the effectiveness of female controlled physical and chemical barrier methods in preventing STI/HIV transmission, to examine recent reviews on microbicide development, and to highlight promising research directions. To discuss challenges in conducting effectiveness research and in translating results to public health intervention.

Methods: Systematic review of articles that examined the disease prevention effectiveness of at least one female controlled barrier method. Review of conference abstracts that presented clinical and preclinical microbicide data.

Results: Randomised controlled trials provide evidence that female condoms confer as much protection from STIs as male condoms. Observational studies suggest that the diaphragm protects against STI pathogens. Several microbicide effectiveness studies are under way and new directions, such as adaptation of therapeutic agents as preventive products, are being examined. Substantial attention is now given to product formulation and novel delivery strategies. Combining microbicide products with different mechanisms of action as well as combining chemical and physical barriers will be necessary to maximise prevention effectiveness.

Conclusions: Increased investment in the development and identification of female controlled barrier methods offers promise that additional products will be available in the years ahead. Generalising trial results to a community setting, promoting products that may be less effective than male condoms, and bringing an effective product to scale introduce public health challenges that warrant attention. The need for female controlled barrier methods that provide women with the opportunity to take an active role in reducing their STI/HIV risk are urgently needed and constitute an essential tool to prevent continued spread of these infections.

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Selected References

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  1. Adams J., Hillman M. The risk compensation theory and bicycle helmets. Inj Prev. 2001 Jun;7(2):89–91. doi: 10.1136/ip.7.2.89. [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. Alves Katia, Shafer Kimberly Page, Caseiro Marcos, Rutherford George, Falcao Maria Elvira, Sucupira Maria Cecília, Busch Michael P., Rawal Bhupat D., Diaz Ricardo S. Risk factors for incident HIV infection among anonymous HIV testing site clients in Santos, Brazil: 1996-1999. J Acquir Immune Defic Syndr. 2003 Apr 15;32(5):551–559. doi: 10.1097/00126334-200304150-00014. [DOI] [PubMed] [Google Scholar]
  3. Austin H., Louv W. C., Alexander W. J. A case-control study of spermicides and gonorrhea. JAMA. 1984 Jun 1;251(21):2822–2824. [PubMed] [Google Scholar]
  4. Becker T. M., Wheeler C. M., McGough N. S., Stidley C. A., Parmenter C. A., Dorin M. H., Jordan S. W. Contraceptive and reproductive risks for cervical dysplasia in southwestern Hispanic and non-Hispanic white women. Int J Epidemiol. 1994 Oct;23(5):913–922. doi: 10.1093/ije/23.5.913. [DOI] [PubMed] [Google Scholar]
  5. Beksinska M. E., Rees H. V., Dickson-Tetteh K. E., Mqoqi N., Kleinschmidt I., McIntyre J. A. Structural integrity of the female condom after multiple uses, washing, drying, and re-lubrication. Contraception. 2001 Jan;63(1):33–36. doi: 10.1016/s0010-7824(00)00192-x. [DOI] [PubMed] [Google Scholar]
  6. Berger G. S., Keith L., Moss W. Prevalence of gonorrhoea among women using various methods of contraception. Br J Vener Dis. 1975 Oct;51(5):307–309. doi: 10.1136/sti.51.5.307. [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. Bradbeer C. S., Thin R. N., Tan T., Thirumoorthy T. Prophylaxis against infection in Singaporean prostitutes. Genitourin Med. 1988 Feb;64(1):52–53. doi: 10.1136/sti.64.1.52. [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. Cramer D. W., Goldman M. B., Schiff I., Belisle S., Albrecht B., Stadel B., Gibson M., Wilson E., Stillman R., Thompson I. The relationship of tubal infertility to barrier method and oral contraceptive use. JAMA. 1987 May 8;257(18):2446–2450. [PubMed] [Google Scholar]
  9. Drew W. L., Blair M., Miner R. C., Conant M. Evaluation of the virus permeability of a new condom for women. Sex Transm Dis. 1990 Apr-Jun;17(2):110–112. doi: 10.1097/00007435-199004000-00014. [DOI] [PubMed] [Google Scholar]
  10. Elias C., Coggins C. Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: Where have we been? Where are we going? J Womens Health Gend Based Med. 2001 Mar;10(2):163–173. doi: 10.1089/152460901300039502. [DOI] [PubMed] [Google Scholar]
  11. Farrar D. J., Cu Uvin S., Caliendo A. M., Costello S. F., Murphy D. M., Flanigan T. P., Mayer K. H., Carpenter C. C. Detection of HIV-1 RNA in vaginal secretions of HIV-1-seropositive women who have undergone hysterectomy. AIDS. 1997 Aug;11(10):1296–1297. doi: 10.1097/00002030-199710001-00004. [DOI] [PubMed] [Google Scholar]
  12. Feldblum P. J., Kuyoh M. A., Bwayo J. J., Omari M., Wong E. L., Tweedy K. G., Welsh M. J. Female condom introduction and sexually transmitted infection prevalence: results of a community intervention trial in Kenya. AIDS. 2001 May 25;15(8):1037–1044. doi: 10.1097/00002030-200105250-00012. [DOI] [PubMed] [Google Scholar]
  13. Fleming Thomas R., Richardson Barbra A. Some design issues in trials of microbicides for the prevention of HIV infection. J Infect Dis. 2004 Jul 20;190(4):666–674. doi: 10.1086/422603. [DOI] [PubMed] [Google Scholar]
  14. Fontanet A. L., Saba J., Chandelying V., Sakondhavat C., Bhiraleus P., Rugpao S., Chongsomchai C., Kiriwat O., Tovanabutra S., Dally L. Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial. AIDS. 1998 Oct 1;12(14):1851–1859. doi: 10.1097/00002030-199814000-00017. [DOI] [PubMed] [Google Scholar]
  15. Foss Anna M., Vickerman Peter T., Heise Lori, Watts Charlotte H. Shifts in condom use following microbicide introduction: should we be concerned? AIDS. 2003 May 23;17(8):1227–1237. doi: 10.1097/00002030-200305230-00015. [DOI] [PubMed] [Google Scholar]
  16. French P. P., Latka M., Gollub E. L., Rogers C., Hoover D. R., Stein Z. A. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis. 2003 May;30(5):433–439. doi: 10.1097/00007435-200305000-00010. [DOI] [PubMed] [Google Scholar]
  17. Garg Sanjay, Kandarapu Raghupathi, Vermani Kavita, Tambwekar Kaustubh R., Garg Alka, Waller Donald P., Zaneveld Lourens J. D. Development pharmaceutics of microbicide formulations. Part I: preformulation considerations and challenges. AIDS Patient Care STDS. 2003 Jan;17(1):17–32. doi: 10.1089/108729103321042881. [DOI] [PubMed] [Google Scholar]
  18. Guinan M. E. HIV, heterosexual transmission, and women. JAMA. 1992 Jul 22;268(4):520–521. [PubMed] [Google Scholar]
  19. Harrison Polly F., Rosenberg Zeda, Bowcut Jana. Topical microbicides for disease prevention: status and challenges. Clin Infect Dis. 2003 May 8;36(10):1290–1294. doi: 10.1086/374834. [DOI] [PubMed] [Google Scholar]
  20. Hildesheim A., Brinton L. A., Mallin K., Lehman H. F., Stolley P., Savitz D. A., Levine R. Barrier and spermicidal contraceptive methods and risk of invasive cervical cancer. Epidemiology. 1990 Jul;1(4):266–272. doi: 10.1097/00001648-199007000-00003. [DOI] [PubMed] [Google Scholar]
  21. Hu J., Gardner M. B., Miller C. J. Simian immunodeficiency virus rapidly penetrates the cervicovaginal mucosa after intravaginal inoculation and infects intraepithelial dendritic cells. J Virol. 2000 Jul;74(13):6087–6095. doi: 10.1128/jvi.74.13.6087-6095.2000. [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Jacobson D. L., Peralta L., Graham N. M., Zenilman J. Histologic development of cervical ectopy: relationship to reproductive hormones. Sex Transm Dis. 2000 May;27(5):252–258. doi: 10.1097/00007435-200005000-00003. [DOI] [PubMed] [Google Scholar]
  23. Joanis C., Latka M., Glover L. H., Hamel S. Structural integrity of the female condom after a single use, washing, and disinfection. Contraception. 2000 Aug;62(2):63–72. doi: 10.1016/s0010-7824(00)00142-6. [DOI] [PubMed] [Google Scholar]
  24. Keith L., Berer G. S., Moss W. Cervical gonorrhea in women using different methods of contraception. J Am Vener Dis Assoc. 1976 Sep;3(1):17–19. [PubMed] [Google Scholar]
  25. Kelaghan J., Rubin G. L., Ory H. W., Layde P. M. Barrier-method contraceptives and pelvic inflammatory disease. JAMA. 1982 Jul 9;248(2):184–187. [PubMed] [Google Scholar]
  26. Keller M. J., Klotman M. E., Herold B. C. Development of topical microbicides for prevention of human immunodeficiency virus and herpes simplex virus. Am J Reprod Immunol. 2003 May;49(5):279–284. doi: 10.1034/j.1600-0897.2003.00044.x. [DOI] [PubMed] [Google Scholar]
  27. Lard-Whiteford Sheryl L., Matecka Dorota, O'Rear Julian J., Yuen Ita S., Litterst Charles, Reichelderfer Patricia, International Working Group on Microbicides Recommendations for the nonclinical development of topical microbicides for prevention of HIV transmission: an update. J Acquir Immune Defic Syndr. 2004 May 1;36(1):541–552. doi: 10.1097/00126334-200405010-00001. [DOI] [PubMed] [Google Scholar]
  28. Lawson M. Louise, Macaluso Maurizio, Duerr Ann, Hortin Glen, Hammond Karen R., Blackwell Richard, Artz Lynn, Bloom Amy. Partner characteristics, intensity of the intercourse, and semen exposure during use of the female condom. Am J Epidemiol. 2003 Feb 15;157(4):282–288. doi: 10.1093/aje/kwf211. [DOI] [PubMed] [Google Scholar]
  29. Macaluso Maurizio, Lawson M. Louise, Hortin Glen, Duerr Ann, Hammond Karen R., Blackwell Richard, Bloom Amy. Efficacy of the female condom as a barrier to semen during intercourse. Am J Epidemiol. 2003 Feb 15;157(4):289–297. doi: 10.1093/aje/kwf212. [DOI] [PubMed] [Google Scholar]
  30. Magder L. S., Harrison H. R., Ehret J. M., Anderson T. S., Judson F. N. Factors related to genital Chlamydia trachomatis and its diagnosis by culture in a sexually transmitted disease clinic. Am J Epidemiol. 1988 Aug;128(2):298–308. doi: 10.1093/oxfordjournals.aje.a114970. [DOI] [PubMed] [Google Scholar]
  31. Malcolm Karl, Woolfson David, Russell Julie, Andrews Chris. In vitro release of nonoxynol-9 from silicone matrix intravaginal rings. J Control Release. 2003 Sep 4;91(3):355–364. doi: 10.1016/s0168-3659(03)00260-8. [DOI] [PubMed] [Google Scholar]
  32. Martin Jeffrey N., Roland Michelle E., Neilands Torsten B., Krone Melissa R., Bamberger Joshua D., Kohn Robert P., Chesney Margaret A., Franses Karena, Kahn James O., Coates Thomas J. Use of postexposure prophylaxis against HIV infection following sexual exposure does not lead to increases in high-risk behavior. AIDS. 2004 Mar 26;18(5):787–792. doi: 10.1097/00002030-200403260-00010. [DOI] [PubMed] [Google Scholar]
  33. McCormack W. M., Rosner B., McComb D. E., Evrard J. R., Zinner S. H. Infection with Chlamydia trachomatis in female college students. Am J Epidemiol. 1985 Jan;121(1):107–115. doi: 10.1093/oxfordjournals.aje.a113971. [DOI] [PubMed] [Google Scholar]
  34. Misegades L., Page-Shafer K., Halperin D., McFarland W., YWS Study Investigators Group. Young Women's Survey Anal intercourse among young low-income women in California: an overlooked risk factor for HIV? AIDS. 2001 Mar 9;15(4):534–535. doi: 10.1097/00002030-200103090-00017. [DOI] [PubMed] [Google Scholar]
  35. Moench T. R., Chipato T., Padian N. S. Preventing disease by protecting the cervix: the unexplored promise of internal vaginal barrier devices. AIDS. 2001 Sep 7;15(13):1595–1602. doi: 10.1097/00002030-200109070-00001. [DOI] [PubMed] [Google Scholar]
  36. Padian Nancy S. Evidence-based prevention: increasing the efficiency of HIV intervention trials. J Infect Dis. 2004 Jul 20;190(4):663–665. doi: 10.1086/422607. [DOI] [PubMed] [Google Scholar]
  37. Park B. J., Stergachis A., Scholes D., Heidrich F. E., Holmes K. K., Stamm W. E. Contraceptive methods and the risk of Chlamydia trachomatis infection in young women. Am J Epidemiol. 1995 Oct 1;142(7):771–778. doi: 10.1093/oxfordjournals.aje.a117709. [DOI] [PubMed] [Google Scholar]
  38. Patterson B. K., Landay A., Andersson J., Brown C., Behbahani H., Jiyamapa D., Burki Z., Stanislawski D., Czerniewski M. A., Garcia P. Repertoire of chemokine receptor expression in the female genital tract: implications for human immunodeficiency virus transmission. Am J Pathol. 1998 Aug;153(2):481–490. doi: 10.1016/S0002-9440(10)65591-5. [DOI] [PMC free article] [PubMed] [Google Scholar]
  39. Pinkerton S. D. Sexual risk compensation and HIV/STD transmission: empirical evidence and theoretical considerations. Risk Anal. 2001 Aug;21(4):727–736. doi: 10.1111/0272-4332.214146. [DOI] [PubMed] [Google Scholar]
  40. Potter Bill, Gerofi John, Pope Mike, Farley Tim. Structural integrity of the polyurethane female condom after multiple cycles of disinfection, washing, drying and relubrication. Contraception. 2003 Jan;67(1):65–72. doi: 10.1016/s0010-7824(02)00418-3. [DOI] [PubMed] [Google Scholar]
  41. Quinn R. W., O'Reilly K. R. Contraceptive practices of women attending the Sexually Transmitted Disease Clinic in Nashville, Tennessee. Sex Transm Dis. 1985 Jul-Sep;12(3):99–102. doi: 10.1097/00007435-198507000-00001. [DOI] [PubMed] [Google Scholar]
  42. Rosenberg M. J., Davidson A. J., Chen J. H., Judson F. N., Douglas J. M. Barrier contraceptives and sexually transmitted diseases in women: a comparison of female-dependent methods and condoms. Am J Public Health. 1992 May;82(5):669–674. doi: 10.2105/ajph.82.5.669. [DOI] [PMC free article] [PubMed] [Google Scholar]
  43. Sherwood J. K., Zeitlin L., Whaley K. J., Cone R. A., Saltzman M. Controlled release of antibodies for long-term topical passive immunoprotection of female mice against genital herpes. Nat Biotechnol. 1996 Apr;14(4):468–471. doi: 10.1038/nbt0496-468. [DOI] [PubMed] [Google Scholar]
  44. Smith J. B., Nkhama G., Trottier D. A. Female condom reuse in Lusaka, Zambia: evidence from 12 cases. J Urban Health. 2001 Dec;78(4):638–646. doi: 10.1093/jurban/78.4.638. [DOI] [PMC free article] [PubMed] [Google Scholar]
  45. Soper D. E., Shoupe D., Shangold G. A., Shangold M. M., Gutmann J., Mercer L. Prevention of vaginal trichomoniasis by compliant use of the female condom. Sex Transm Dis. 1993 May-Jun;20(3):137–139. doi: 10.1097/00007435-199305000-00003. [DOI] [PubMed] [Google Scholar]
  46. Stein Z. A. HIV prevention: the need for methods women can use. Am J Public Health. 1990 Apr;80(4):460–462. doi: 10.2105/ajph.80.4.460. [DOI] [PMC free article] [PubMed] [Google Scholar]
  47. Stein Zena A., Myer Landon, Susser Mervyn. The design of prophylactic trials for HIV: the case of microbicides. Epidemiology. 2003 Jan;14(1):80–84. doi: 10.1097/00001648-200301000-00018. [DOI] [PubMed] [Google Scholar]
  48. Steiner Markus J., Feldblum Paul J., Padian Nancy. Invited commentary: condom effectiveness-will prostate-specific antigen shed new light on this perplexing problem? Am J Epidemiol. 2003 Feb 15;157(4):298–302. doi: 10.1093/aje/kwf213. [DOI] [PubMed] [Google Scholar]
  49. Stone Alan. Microbicides: a new approach to preventing HIV and other sexually transmitted infections. Nat Rev Drug Discov. 2002 Dec;1(12):977–985. doi: 10.1038/nrd959. [DOI] [PubMed] [Google Scholar]
  50. Tabet S. R., Surawicz C., Horton S., Paradise M., Coletti A. S., Gross M., Fleming T. R., Buchbinder S., Haggitt R. C., Levine H. Safety and toxicity of nonoxynol-9 gel as a rectal microbicide. Sex Transm Dis. 1999 Nov;26(10):564–571. doi: 10.1097/00007435-199911000-00005. [DOI] [PubMed] [Google Scholar]
  51. Tsai Che-Chung, Emau Peter, Jiang Yonghou, Tian Baoping, Morton William R., Gustafson Kirk R., Boyd Michael R. Cyanovirin-N gel as a topical microbicide prevents rectal transmission of SHIV89.6P in macaques. AIDS Res Hum Retroviruses. 2003 Jul;19(7):535–541. doi: 10.1089/088922203322230897. [DOI] [PubMed] [Google Scholar]
  52. Van Damme L., Wright A., Depraetere K., Rosenstein I., Vandersmissen V., Poulter L., McKinlay M., Van Dyck E., Weber J., Profy A. A phase I study of a novel potential intravaginal microbicide, PRO 2000, in healthy sexually inactive women. Sex Transm Infect. 2000 Apr;76(2):126–130. doi: 10.1136/sti.76.2.126. [DOI] [PMC free article] [PubMed] [Google Scholar]
  53. Walsh T. L., Frezieres R. G., Nelson A. L., Wraxall B. G., Clark V. A. Evaluation of prostate-specific antigen as a quantifiable indicator of condom failure in clinical trials. Contraception. 1999 Nov;60(5):289–298. doi: 10.1016/s0010-7824(99)00098-0. [DOI] [PubMed] [Google Scholar]
  54. Wright N. H., Vessey M. P., Kenward B., McPherson K., Doll R. Neoplasia and dysplasia of the cervix uteri and contraception: a possible protective effect of the diaphragm. Br J Cancer. 1978 Aug;38(2):273–279. doi: 10.1038/bjc.1978.198. [DOI] [PMC free article] [PubMed] [Google Scholar]
  55. Wølner-Hanssen P., Eschenbach D. A., Paavonen J., Kiviat N., Stevens C. E., Critchlow C., DeRouen T., Holmes K. K. Decreased risk of symptomatic chlamydial pelvic inflammatory disease associated with oral contraceptive use. JAMA. 1990 Jan 5;263(1):54–59. doi: 10.1001/jama.1990.03440010052029. [DOI] [PubMed] [Google Scholar]
  56. de Zoysa I., Elias C. J., Bentley M. E. Ethical challenges in efficacy trials of vaginal microbicides for HIV prevention. Am J Public Health. 1998 Apr;88(4):571–575. doi: 10.2105/ajph.88.4.571. [DOI] [PMC free article] [PubMed] [Google Scholar]

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