Skip to main content
Erschienen in: AIDS and Behavior 2/2008

01.03.2008 | Review Paper

Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach

verfasst von: Kathleen M. Morrow, Monica S. Ruiz

Erschienen in: AIDS and Behavior | Ausgabe 2/2008

Einloggen, um Zugang zu erhalten

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.
Literatur
Zurück zum Zitat 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
Zurück zum Zitat 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
Zurück zum Zitat 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
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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
Zurück zum Zitat 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.
Zurück zum Zitat 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
Zurück zum Zitat 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
Zurück zum Zitat 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
Zurück zum Zitat 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
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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
Zurück zum Zitat 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
Zurück zum Zitat 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.
Zurück zum Zitat 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).
Zurück zum Zitat 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
Zurück zum Zitat 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
Zurück zum Zitat 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.​
Zurück zum Zitat 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
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Metadaten
Titel
Assessing Microbicide Acceptability: A Comprehensive and Integrated Approach
verfasst von
Kathleen M. Morrow
Monica S. Ruiz
Publikationsdatum
01.03.2008
Verlag
Springer US
Erschienen in
AIDS and Behavior / Ausgabe 2/2008
Print ISSN: 1090-7165
Elektronische ISSN: 1573-3254
DOI
https://doi.org/10.1007/s10461-007-9266-z

Weitere Artikel der Ausgabe 2/2008

AIDS and Behavior 2/2008 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Notfall-TEP der Hüfte ist auch bei 90-Jährigen machbar

26.04.2024 Hüft-TEP Nachrichten

Ob bei einer Notfalloperation nach Schenkelhalsfraktur eine Hemiarthroplastik oder eine totale Endoprothese (TEP) eingebaut wird, sollte nicht allein vom Alter der Patientinnen und Patienten abhängen. Auch über 90-Jährige können von der TEP profitieren.

Niedriger diastolischer Blutdruck erhöht Risiko für schwere kardiovaskuläre Komplikationen

25.04.2024 Hypotonie Nachrichten

Wenn unter einer medikamentösen Hochdrucktherapie der diastolische Blutdruck in den Keller geht, steigt das Risiko für schwere kardiovaskuläre Ereignisse: Darauf deutet eine Sekundäranalyse der SPRINT-Studie hin.

Bei schweren Reaktionen auf Insektenstiche empfiehlt sich eine spezifische Immuntherapie

Insektenstiche sind bei Erwachsenen die häufigsten Auslöser einer Anaphylaxie. Einen wirksamen Schutz vor schweren anaphylaktischen Reaktionen bietet die allergenspezifische Immuntherapie. Jedoch kommt sie noch viel zu selten zum Einsatz.

Therapiestart mit Blutdrucksenkern erhöht Frakturrisiko

25.04.2024 Hypertonie Nachrichten

Beginnen ältere Männer im Pflegeheim eine Antihypertensiva-Therapie, dann ist die Frakturrate in den folgenden 30 Tagen mehr als verdoppelt. Besonders häufig stürzen Demenzkranke und Männer, die erstmals Blutdrucksenker nehmen. Dafür spricht eine Analyse unter US-Veteranen.

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.