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Published in: AIDS and Behavior 2/2008

01-03-2008 | Review Paper

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

Authors: Kathleen M. Morrow, Monica S. Ruiz

Published in: AIDS and Behavior | Issue 2/2008

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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.
Literature
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference Bax, R., Douville, K., McCormick, D., Rosenberg, M., Higgins, J., & Bowden, M. (2002). Microbicides—evaluating multiple formulations of C31G. Contraception, 66(5), 365–368.PubMedCrossRef Bax, R., Douville, K., McCormick, D., Rosenberg, M., Higgins, J., & Bowden, M. (2002). Microbicides—evaluating multiple formulations of C31G. Contraception, 66(5), 365–368.PubMedCrossRef
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference Boonstra, H. (2000). Campaign to accelerate microbicide development for STD prevention gets under way. The Guttmacher Report on Public Policy, 3, 3–4. Boonstra, H. (2000). Campaign to accelerate microbicide development for STD prevention gets under way. The Guttmacher Report on Public Policy, 3, 3–4.
go back to reference 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. 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.
go back to reference Denzin, N. K. (1978). The research act: A theoretical introduction to sociological methods (2nd ed.). New York, NY: McGraw Hill. Denzin, N. K. (1978). The research act: A theoretical introduction to sociological methods (2nd ed.). New York, NY: McGraw Hill.
go back to reference 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. 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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.CrossRef 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.CrossRef
go back to reference Heise, L. (1997). Beyond acceptability: Reorienting research on contraceptive choice. In WHO (Ed.), Beyond acceptability: Users’ perspectives on contraception: Reproductive Health Matters. Heise, L. (1997). Beyond acceptability: Reorienting research on contraceptive choice. In WHO (Ed.), Beyond acceptability: Users’ perspectives on contraception: Reproductive Health Matters.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference MDS Working Groups. (2006). The microbicide development strategy. Silver Spring, MD: Alliance for Microbicide Development. MDS Working Groups. (2006). The microbicide development strategy. Silver Spring, MD: Alliance for Microbicide Development.
go back to reference Morrow, K. (2006). The use of qualitative methods in formative and evaluative research. Unpublished presentation, Providence, RI. Morrow, K. (2006). The use of qualitative methods in formative and evaluative research. Unpublished presentation, Providence, RI.
go back to reference 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., 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference 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. 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.
go back to reference 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). 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).
go back to reference Severy, L. J., & Newcomer, S. (2005a). Critical issues in contraceptive and STI acceptability research. Journal of Social Issues, 61(1), 45–65.CrossRef Severy, L. J., & Newcomer, S. (2005a). Critical issues in contraceptive and STI acceptability research. Journal of Social Issues, 61(1), 45–65.CrossRef
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference The Rockefeller Foundation. (2002). Mobilization for microbicides: The decisive decade. Retrieved May 16, 2006, from http://www.global-campaign.org/clientfiles/RockExecSumm.pdf. The Rockefeller Foundation. (2002). Mobilization for microbicides: The decisive decade. Retrieved May 16, 2006, from http://​www.​global-campaign.​org/​clientfiles/​RockExecSumm.​pdf.​
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
go back to reference UNAIDS/WHO. (2005). AIDS epidemic update 2005: Special report on HIV prevention. Geneva, Switzerland. UNAIDS/WHO. (2005). AIDS epidemic update 2005: Special report on HIV prevention. Geneva, Switzerland.
go back to reference 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. 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.
go back to reference WHO. (1997). Beyond acceptability: Users’ perspectives on contraception: Reproductive Health Matters for WHO. WHO. (1997). Beyond acceptability: Users’ perspectives on contraception: Reproductive Health Matters for WHO.
go back to reference Wulf, D., Frost, J., & Darroch, J. E. (1999). Microbicides: A new defense against sexually transmitted diseases. New York, NY: The Alan Guttmacher Institute. Wulf, D., Frost, J., & Darroch, J. E. (1999). Microbicides: A new defense against sexually transmitted diseases. New York, NY: The Alan Guttmacher Institute.
Metadata
Title
Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach
Authors
Kathleen M. Morrow
Monica S. Ruiz
Publication date
01-03-2008
Publisher
Springer US
Published in
AIDS and Behavior / Issue 2/2008
Print ISSN: 1090-7165
Electronic ISSN: 1573-3254
DOI
https://doi.org/10.1007/s10461-007-9266-z

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