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AIDS and Behavior

, Volume 16, Issue 5, pp 1121–1132 | Cite as

A Randomized Controlled Trial to Evaluate a Structural Intervention to Promote the Female Condom in New York State

  • Theresa M. Exner
  • James M. Tesoriero
  • Haven B. Battles
  • Susie Hoffman
  • Joanne E. MantellEmail author
  • Jacqueline Correale
  • Jessica Adams-Skinner
  • Dara A. Shapiro
  • Kirsten Rowe
  • Richard A. Cotroneo
  • Cheng-Shiun Leu
  • Joyce Hunter
  • Susan J. Klein
Original Paper

Abstract

We conducted a structural intervention to promote the female condom (FC), comparing 44 agencies randomized to a Minimal Intervention (MI) [developing action plans for promotion and free access] or an Enhanced Intervention (EI) [with the addition of counselor training]. Intervention effects were evaluated via surveys with agency directors, counselors and clients at baseline and 12 months. Agency-level outcomes of the FC did not differ between the two interventions at follow-up. Counselors in the EI showed significantly greater gains in FC knowledge and positive attitudes, although there was no difference in the proportion of clients counseled on the FC, which significantly increased in both conditions. There was a greater increase in intention to use the FC among clients in EI agencies. Intervention effects were stronger in medical agencies. Findings suggest that making subsidized FCs available and assisting agencies to formulate action plans led to increased FC promotion. Limitations and implications for future research and intervention efforts are discussed.

Keywords

Female condom HIV prevention Structural intervention United States 

Notes

Acknowledgments

This research was supported by a grant from NIMH (NIMH; R01-MH078770; Theresa M. Exner, PhD, Principal Investigator). The HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University is supported by a center grant from the National Institute of Mental Health (P30-MH43520; Principal Investigator: Anke A. Ehrhardt, PhD). We thank the women and men who participated in this study. We also acknowledge the contributions of our collaborators, particularly Alma R. Candelas and Nkechi Oguaghe of the AIDS Institute, who assisted with agency matching and recruitment; Zena Stein, who facilitated buy-in and contributed conceptually to the study; and the Professional Development Program, Rockefeller College, University at Albany, State University of New York, who were central to intervention development and training, particularly Lisa Skill and Linnaea Scavone. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the NationaI Institute of Mental Health, the New York State Department of Health, the New York State Psychiatric Institute, or Columbia University.

References

  1. 1.
    Farr G, Gabelnick H, Sturgen K, Dorflinger L. Contraceptive efficacy and acceptability of the female condom. Am J Public Health. 1994;84(12):1960–4.PubMedCrossRefGoogle Scholar
  2. 2.
    Trussell J. Contraceptive efficacy of the Reality™ female condom. Contraception. 1998;58(3):147–8.CrossRefGoogle Scholar
  3. 3.
    Lytle CD, Routson LB, Seaborn GB, Dixon LG, Bushar HF, Cyr WH. An in vitro evaluation of condoms as barriers to a small virus. Sex Transm Dis. 1997;24(3):161–4.PubMedCrossRefGoogle Scholar
  4. 4.
    Drew WL, Blair M, Miner RC, Conant M. Evaluation of the virus permeability of a new condom for women. Sex Transm Dis. 1990;17(2):110–2.PubMedCrossRefGoogle Scholar
  5. 5.
    Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infection and HIV: current evidence and future research directions. Sex Transm Infec. 2005;81(3):193–200.CrossRefGoogle Scholar
  6. 6.
    Voeller B, Coulter S, Mayhan K. Gas, dye, and viral transport through polyurethane condoms (Letter to the Editor). JAMA. 1991;266(21):2986–7.PubMedCrossRefGoogle Scholar
  7. 7.
    Feldblum PJ, Kuyoh MA, Bwayo JJ, et al. Female condom introduction and sexually transmitted infection prevalence: results of a community intervention trial in Kenya. AIDS. 2001;15(8):1037–44.PubMedCrossRefGoogle Scholar
  8. 8.
    Fontanet AL, Saba J, Chandelying V, et al. 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;12(14):1851–9.PubMedCrossRefGoogle Scholar
  9. 9.
    French PP, Latka M, Gollub EL, Rogers C, Hoover DR, Stein ZA. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis. 2003;30(5):433–9.PubMedCrossRefGoogle Scholar
  10. 10.
    Artz L, Maculuso MM, Brill I, et al. Effectiveness of an intervention promoting the female condom to patients at sexually transmitted disease clinics. Am J Public Health. 2000;90(2):237–44.PubMedCrossRefGoogle Scholar
  11. 11.
    Choi KH, Gregorich SE, Anderson K, Grinstead O, Gomez CA. Patterns and predictors of female condom use among ethnically diverse women attending family planning clinics. Sex Transm Dis. 2003;30(1):91–8.PubMedCrossRefGoogle Scholar
  12. 12.
    Choi KH, Hoff C, Gregorich SE, Grinstead O, Gomez C, Hussey W. The efficacy of female condom skills training in HIV risk reduction among women: a randomized controlled trial. Am J Public Health. 2008;98(10):1841–8.PubMedCrossRefGoogle Scholar
  13. 13.
    Hoke TH, Feldblum PJ, Van Damme K, et al. Temporal trends in sexually transmitted infection prevalence and condom use following introduction of the female condom to Madagascar sex workers. Int J STD AIDS. 2007;18(17):461–6.PubMedCrossRefGoogle Scholar
  14. 14.
    Latka M, Gollub EL, French P, Stein Z. Male-condom and female-condom use among women after counseling in a risk-reduction hierarchy for STD prevention. Sex Transm Dis. 2001;27(8):431–7.Google Scholar
  15. 15.
    Musaba E, Morrison CS, Sunkutu MR, Wong EL. Long-term use of the female condom among couples at high risk of human immunodeficiency virus infection in Zambia. Sex Transm Dis. 1998;25(5):260–4.PubMedCrossRefGoogle Scholar
  16. 16.
    Cecil H, Perry MJ, Seal DW, et al. The female condom: what we have learned thus far. AIDS Behav. 1998;2(3):241–56.CrossRefGoogle Scholar
  17. 17.
    WHO. (1997). The Female Condom: A review. Geneva: World Health Organization. WHO/UNAIDS.Google Scholar
  18. 18.
    Female Health Company (2011). The Female Health Company. 2010 annual report. Available at: http://www.femalehealth.com/images/FHC_AR_2010.pdf (Accessed 27 December 2011).
  19. 19.
    Rubin R. (March 2, 2011). Female condoms are gaining ground. USA Today. Available at: http://yourlife.usatoday.com/health/medical/womenshealth/story/2011/03/Female-condoms-are-gaining-ground/44422408/1.
  20. 20.
    Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of HIV/AIDS Prevention (2011, August). HIV among women. Available at: http://www.cdc.gov/hiv/topics/women/pdf/women.pdf.
  21. 21.
    Hoffman S, Mantell J, Exner T, et al. The future of the female condom. Perspect Sex Reprod Health. 2004;36(3):120–6.PubMedCrossRefGoogle Scholar
  22. 22.
    Jones DL, Weiss SM, Chitalu N, et al. Acceptability and use of sexual barrier products and lubricants among HIV-seropositive Zambian men. AIDS Patient Care STDs. 2008;22(12):1015–20.PubMedCrossRefGoogle Scholar
  23. 23.
    Napierala S, Kang MS, Chipato T, Padian N, van der Straten A. Female condom uptake and acceptability in Zimbabwe. AIDS Educ Prev. 2008;20(2):121–34.PubMedCrossRefGoogle Scholar
  24. 24.
    Simmons R, Hall P, Diaz J, Diaz M, Fajans P, Satia J. The strategic approach to contraceptive introduction. Stud Fam Plann. 1997;28(2):79–94.PubMedCrossRefGoogle Scholar
  25. 25.
    Mantell J, Hoffman S, Exner T, Stein ZA, Atkins K. Family planning providers’ perspectives on dual protection. Perspect Sex Reprod Health. 2003;35(2):71–8.PubMedCrossRefGoogle Scholar
  26. 26.
    Mantell JE, West BS, Sue K, et al. Health care providers: a missing link in understanding acceptability of the female condom. AIDS Educ Prev. 2011;23(1):65–78.PubMedCrossRefGoogle Scholar
  27. 27.
    Abdool Karim Q, Preston-Whyte E, Abdool Karim SS. Accessibility of condoms to teenagers at family planning clinics in Durban. Part II: a provider’s perspective. S Afr Med J. 1992;82(5):360–2.Google Scholar
  28. 28.
    Speizer IS, Hotchkiss DR, Magnani RJ, Hubbard B, Nelson K. Do service providers in Tanzania unnecessarily restrict clients’ access to contraceptive methods? Int Fam Plan Perspect. 2000;26(1):13–20.CrossRefGoogle Scholar
  29. 29.
    Barbosa RM, Kalckmann S, Berquo E, Stein Z. Notes on the female condom: experiences in Brazil. Int J STD AIDS. 2007;18(4):261–6.PubMedCrossRefGoogle Scholar
  30. 30.
    Mantell JE, Scheepers E, Abdool Karim Q. Introducing the female condom through the public health sector: experiences from South Africa. AIDS Care. 2000;12(5):589–601.PubMedCrossRefGoogle Scholar
  31. 31.
    Mqhayi M, Beksinska M, Smit J, et al. Introduction of the female condom in South Africa: Programme activities and performance 1998–2001. Johannesburg (South Africa): Reproductive Health Research Unit, Draft Report, 2003.Google Scholar
  32. 32.
    Weeks MR, Hilario H, Li J, Coman E, Abbott AM, Sylla L, Corbett M, Dickson-Gomez J. Multilevel social influences on female condom use and adoption among women in the urban United States. AIDS Patient Care STDs. 2010;24(5):297–309.PubMedCrossRefGoogle Scholar
  33. 33.
    UNAIDS, STI/HIV/AIDS Prevention Center, & WHO. (2000). Need and acceptability of female condom among women in Thanh Xuan Commune and Dong Da District, Hanoi. Hanoi: UNAIDS, STI/HIV/AIDS, Prevention Center, World Health Organization, 2000.Google Scholar
  34. 34.
    Blankenship KM, Bray SJ, Merson MH. Structural interventions in public health. AIDS. 2000;14(suppl 1):S11–S21.PubMedCrossRefGoogle Scholar
  35. 35.
    Bauermeister JA, Tross S, Ehrhardt AA. A review of HIV/AIDS system-level interventions. AIDS Behav. 2009;13(3):430–48.PubMedCrossRefGoogle Scholar
  36. 36.
    Mantell JE, Hoffman S, Weiss E, et al. The acceptability of the female condom: perspectives of family planning providers in New York City, South Africa, and Nigeria. J Urban Health. 2001;78(4):658–68.PubMedCrossRefGoogle Scholar
  37. 37.
    Penman-Aguilar A, Hall J, Artz L, et al. Presenting the female condom to men: a dyadic analysis of effect of the woman’s approach. Women’s Health. 2002;35(1):37–51.CrossRefGoogle Scholar
  38. 38.
    Rivers K, Aggleton P, Elizondo J, et al. Gender relations, sexual communication and the female condom. Critical Public Health. 1998;8(4):273–89.CrossRefGoogle Scholar
  39. 39.
    Artz L, Demand M, Pulley L, Posner SF, Macaluso M. Predictors of difficulty inserting the female condom. Contraception. 2002;65(2):151–7.PubMedCrossRefGoogle Scholar
  40. 40.
    Bandura A, editor. Social foundations of thought and action: a social cognitive theory. Englewood Cliffs: Prentice-Hall; 1986.Google Scholar
  41. 41.
    Bandura A, editor. A social cognitive approach to the exercise of control over AIDS infection. Beverly Hills: Sage; 1992.Google Scholar
  42. 42.
    Bruce J. Fundamental elements of quality of care: a simple framework. Stud Fam Plann. 1990;21(2):61–91.PubMedCrossRefGoogle Scholar
  43. 43.
    Green LW, Kreuter MW, editors. Health promotion planning: an educational and environmental approach. 3rd ed. Mayfield: Mountain View; 1999.Google Scholar
  44. 44.
    Neilands TB, Choi K-H. A validation and reduced form of the female condom attitudes scale. AIDS Educ Prev. 2002;14(2):158–71.PubMedCrossRefGoogle Scholar
  45. 45.
    Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrik. 1986;73(1):13–22.CrossRefGoogle Scholar
  46. 46.
    Philpott A, Knerr W, Boydell V. Pleasure and prevention: when good sex is safer sex. Reprod Health Matters. 2006;14(28):23–31.PubMedCrossRefGoogle Scholar
  47. 47.
    Choi KH, Roberts KJ, Gomez C, Grinstead O. Facilitators and barriers to use of the female condom: qualitative interviews with women of diverse ethnicities. Women’s Health. 1999;30(1):53–70.CrossRefGoogle Scholar
  48. 48.
    Rogers EM. Diffusion of innovations (4th ed). New York: The Free Press; 1995.Google Scholar
  49. 49.
    Fixsen DL, Blase KA. Creating new realities: program development and dissemination. J Appl Behav Anal. 1993;26(4):597–615.PubMedCrossRefGoogle Scholar
  50. 50.
    Cronbach LJ. Test validation. In: Thorndike RL, editor. Educational measurement. Washington: American Council on Education; 1971.Google Scholar
  51. 51.
    Cronbach LJ, Meehl PE. Construct validation in psychological tests. Psych Bull. 1955;52:281–302.CrossRefGoogle Scholar
  52. 52.
    Kaler A. The female condom in North America: selling the technology of ‘empowerment’. J Gender Studies. 2004;13(2):139–52.CrossRefGoogle Scholar
  53. 53.
    Latka M. Female-initiated barrier methods for the prevention of STI/HIV: where are we now? Where should we go? J Urban Health. 2001;78(4):571–80.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • Theresa M. Exner
    • 1
  • James M. Tesoriero
    • 3
  • Haven B. Battles
    • 3
  • Susie Hoffman
    • 1
    • 2
  • Joanne E. Mantell
    • 1
    Email author
  • Jacqueline Correale
    • 1
  • Jessica Adams-Skinner
    • 1
  • Dara A. Shapiro
    • 3
  • Kirsten Rowe
    • 3
  • Richard A. Cotroneo
    • 3
  • Cheng-Shiun Leu
    • 1
    • 4
  • Joyce Hunter
    • 1
  • Susan J. Klein
    • 3
  1. 1.HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia UniversityNew YorkUSA
  2. 2.Department of EpidemiologyJoseph L. Mailman School of Public Health, Columbia UniversityNew YorkUSA
  3. 3.AIDS Institute, New York State Department of HealthAlbanyUSA
  4. 4.Department of BiostatisticsJoseph L. Mailman School of Public Health, Columbia UniversityNew YorkUSA

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