Skip to main content

Advertisement

SpringerLink
Log in

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

  • Review Paper
  • Published:
AIDS and Behavior Aims and scope Submit manuscript

Abstract

A safe, effective, and acceptable microbicide is needed in order to decisively impact the global AIDS pandemic. As such, microbicide acceptability research is of paramount importance. In order to best utilize limited financial resources and save precious development time, acceptability studies should be fully integrated into preclinical and clinical trial contexts where candidate products are being developed and tested. An integrated approach for examining theoretically valid and relevant variables is needed so that data across studies and products can more effectively advance the field. We propose an approach for measuring factors related to microbicide acceptability in each phase of product development, and dependent on what product-specific knowledge is already established in the field. We discuss the roles that behavioral and social science methodologies should play in all phases of microbicide development, as well as the challenges faced when conducting acceptability research in the context of preclinical and clinical trial settings.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  • Barnhart, K. T., Pretorius, E. S., Timbers, K., Shera, D., Shabbout, M., & Malamud, D. (2004). In vivo distribution of a vaginal gel: MRI evaluation of the effects of gel volume, time and simulated intercourse. Contraception, 70(6), 498–505.

    Article  PubMed  CAS  Google Scholar 

  • Bax, R., Douville, K., McCormick, D., Rosenberg, M., Higgins, J., & Bowden, M. (2002). Microbicides—evaluating multiple formulations of C31G. Contraception, 66(5), 365–368.

    Article  PubMed  CAS  Google Scholar 

  • Bentley, M. E., Morrow, K., Fullem, A., Chesney, M. A., Horton, S. D., Rosenberg, Z., et al. (2000). Acceptability of a novel vaginal microbicide during a safety trial among low-risk women. Family Planning Perspectives, 32(4), 184–188.

    Article  PubMed  CAS  Google Scholar 

  • Boonstra, H. (2000). Campaign to accelerate microbicide development for STD prevention gets under way. The Guttmacher Report on Public Policy, 3, 3–4.

    Google Scholar 

  • Coggins, C., Blanchard, K., Alvarez, F., Brache, V., Weisberg, E., Kilmarx, P., et al. (2000). Safety and acceptability of lambda-carageenan-containing vaginal microbicide gel PC-503. Paper presented at the Microbicide 2000, Washington, DC.

  • Denzin, N. K. (1978). The research act: A theoretical introduction to sociological methods (2nd ed.). New York, NY: McGraw Hill.

    Google Scholar 

  • Denzin, N. K., & Lincoln, Y. S. (1998). Introduction. In N. K. Denzin, & Y. S. Lincoln (Eds.), Strategies of qualitative inquiry. Thousand Oaks, CA: Sage Publications.

    Google Scholar 

  • Elias, C., & Coggins, C. (2001). Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: Where have we been? Where are we going? Journal of Women’s Health and Gender-Based Medicine, 10(2), 163–173.

    Article  PubMed  CAS  Google Scholar 

  • El-Sadr, W. M., Mayer, K. H., Maslankowski, L., Hoesley, C., Justman, J., Gai, F., Mauck, C., Absalon, J., Carballo-Dieguez, A., Morrow, K., Mâsse., B, Soto-Torres, L. & Kwiecien, A for the HIV Prevention Trials Network (HPTN) 049 Protocol Team. (2006). Safety and Acceptability of Cellulose Sulfate as a Vaginal Microbicide in HIV-infected Women. AIDS, 20(8), 1109–1116.

  • Finley, B. M., Plescia, C. J., Harrison, P. F., & des Vignes, F. N. (2006, Aug 13–18). An analytical overview of the microbicide preclinical and clinical pipeline. Paper presented at the AIDS 2006, Toronto, Canada.

  • Fuchs, E., Wahl, R., Macura, K., Leal, J., Grohskopf, L., & Hendrix, C. (2005). Imaging the distribution and clearance of a rectal microbicide gel and semen surrogate in the lower gastrointestinal tract. Clinical Pharmacology and Therapeutics, 77(2), 60.

    Google Scholar 

  • Geonotti, A. R., & Katz, D. F. (2005). Erosion of microbicide formulation coating layers: Effects of contact and shearing with vaginal fluid or semen. Journal of Pharmaceutical Sciences, 94, 1705–1712.

    Article  CAS  Google Scholar 

  • Heise, L. (1997). Beyond acceptability: Reorienting research on contraceptive choice. In WHO (Ed.), Beyond acceptability: Users’ perspectives on contraception: Reproductive Health Matters.

  • Kieweg, S. L., Geonnotti, A. R., & Katz, D. F. (2004). Gravity-induced coating flows of vaginal gel formulations: In vitro experimental analysis. Journal of Pharmaceutical Sciences, 93(12), 2941–2952.

    Article  PubMed  CAS  Google Scholar 

  • Kieweg, S. L., & Katz, D. F. (2006). Squeezing flows of vaginal gel formulations relevant to microbicide drug delivery. Journal of Biomechanical Engineering, 128(4), 540–553.

    Article  PubMed  Google Scholar 

  • Mantell, J. E., Myer, L., Carballo-Dieguez, A., Stein, Z., Ramjee, G., Morar, N. S., et al. (2005). Microbicide acceptability research: Current approaches and future directions. Social Science and Medicine, 60(2), 319–330.

    Article  PubMed  Google Scholar 

  • Mason, T. H., Foster, S. E., Finlinson, H. A., Morrow, K., Rosen, R., Vining, S., et al. (2003). Perspectives related to the potential use of vaginal microbicides among drug-involved women: Focus groups in three cities in the United States and Puerto Rico. AIDS and Behavior, 7(4), 339–351.

    Article  PubMed  Google Scholar 

  • MDS Working Groups. (2006). The microbicide development strategy. Silver Spring, MD: Alliance for Microbicide Development.

    Google Scholar 

  • Morrow, K. (2006). The use of qualitative methods in formative and evaluative research. Unpublished presentation, Providence, RI.

  • Morrow, K., Costello, T., & Rosen, R. (2003a). Coloring in the lines: Using qualitative data to enhance quantitative findings: The case of microbicide acceptability. Paper presented at the Society of Behavioral Medicine, Salt Lake City, Utah.

  • Morrow, K., Rosen, R., Richter, L., Emans, A., Forbes, A., Day, J., et al. (2003b). The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase I clinical trial. Journal of Women’s Health, 12(7), 655–666.

    Article  PubMed  Google Scholar 

  • Murphy, S. T., Miller, L. C., Moore, J., & Clark, L. F. (2000). Preaching to the choir: Preference for female-controlled methods of HIV and sexually transmitted disease prevention. American Journal of Public Health, 90(7), 1135–1137.

    Article  PubMed  CAS  Google Scholar 

  • Ramjee, G., Abdool Karim, S. S., Morar, N., Gwamanda, Z., Xulu, G., Ximba, T., et al. (1999). Acceptability of a vaginal microbicide among female sex workers. South African Medical Journal, 89(6), 673–676.

    Google Scholar 

  • Rosen, R., Morrow, K., Carballo-Dieguez, A., Mantell, J., Hoffman, S., Gai, F., et al. (under review). The acceptability of an antiretroviral vaginal microbicide, Tenofovir Gel, among female participants in a phase I trial (HPTN 050).

  • Severy, L. J., & Newcomer, S. (2005a). Critical issues in contraceptive and STI acceptability research. Journal of Social Issues, 61(1), 45–65.

    Article  Google Scholar 

  • Severy, L. J., Tolley, E., Woodsong, C., & Guest, G. (2005b). A framework for examining the sustained acceptability of microbicides. AIDS and Behavior, 9(1), 121–131.

    Article  PubMed  Google Scholar 

  • The Rockefeller Foundation. (2002). Mobilization for microbicides: The decisive decade. Retrieved May 16, 2006, from http://www.global-campaign.org/clientfiles/RockExecSumm.pdf.

  • Tolley, E. E., & Severy, L. J. (2006). Integrating behavioral and social science research into microbicide clinical trials: Challenges and opportunities. American Journal of Public Health, 96(1), 79–83.

    Article  PubMed  Google Scholar 

  • UNAIDS/WHO. (2005). AIDS epidemic update 2005: Special report on HIV prevention. Geneva, Switzerland.

  • Watts, C., Kumaranayake, L., Vickerman, P., & Terris-Prestholt, F. (2002). New hope for HIV prevention: Projections of the impact of microbicides. Paper presented at the Microbicides 2002, May 12–15, Antwerp, Belgium.

  • WHO. (1997). Beyond acceptability: Users’ perspectives on contraception: Reproductive Health Matters for WHO.

  • Wulf, D., Frost, J., & Darroch, J. E. (1999). Microbicides: A new defense against sexually transmitted diseases. New York, NY: The Alan Guttmacher Institute.

    Google Scholar 

Download references

Acknowledgments

Dr Ruiz is now at the Foundation for AIDS Research (amfAR). Some of the conceptualizations by the first author (Morrow) are derived from work completed under grant number R01 MH064455, R21 MH080591 and CFAR P30 AI42853, and well as the culmination of lessons learned through her work on the following projects: HIVNET 009 N01-AI-35176 and NO1-AI-45200, N01-AI-35176, 1RO1DA10871, HPTU U01 AI48040 (HPTN 020, HPTN 050 and HPTN 049). The authors would like to thank Dr David Katz for his thoughts on conceptualizing preclinical acceptability, as well as Drs Roberta Black and Jim Turpin for their editorial comments on early drafts of this manuscript.

The views expressed in this paper do not necessarily represent the views of the Department of Health and Human Services, the National Institutes of Health, or any of its constituent units.

Author information

Authors and Affiliations

  1. Centers for Behavioral and Preventive Medicine, Department of Psychiatry & Human Behavior, The Miriam Hospital and the Warren Alpert Medical School of Brown University, Coro West, Suite 500, One Hoppin Street, Providence, RI, USA

    Kathleen M. Morrow

  2. National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA

    Monica S. Ruiz

Authors
  1. Kathleen M. Morrow
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Monica S. Ruiz
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kathleen M. Morrow.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Morrow, K.M., Ruiz, M.S. Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach. AIDS Behav 12, 272–283 (2008). https://doi.org/10.1007/s10461-007-9266-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10461-007-9266-z

Keywords

Search

Navigation