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Author Notes:

Correspondence: Paula M. Frew, Emory University, Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, 603 Church Street, Decatur, GA 30030, USA. Telephone: 404-712-8546. Fax: 404-712-9017. Email: pfrew@emory.edu.

Acknowledgments: The authors wish to thank the study volunteers for their participation and support of this study.

The authors also acknowledge the support by the United State Agency for International Development (USAID) for CONRAD personnel involved in the study.

Subjects:

Research Funding:

Study support was provided by the Centers for Disease Control and Prevention (200-2003-029494), Emory Center for AIDS Research (P30 AI050409), the Emory HIV/AIDS Clinical Trials Unit (U01 AI069418).

Keywords:

  • HIV/AIDS
  • Microbicide
  • Women
  • Minorities
  • Clinical trials
  • Product acceptability

Assessment of a Microbicide Candidate among a Diverse Cohort of Urban Southern US Women and their Male Sexual Partners

Tools:

Journal Title:

Journal of AIDS and Clinical Research

Volume:

Volume 4, Number 4

Publisher:

, Pages S4-004

Type of Work:

Article | Final Publisher PDF

Abstract:

Background: This mixed methods study reports on product acceptance from a Phase I clinical trial of a candidate non-nucleoside reverse transcriptase inhibitor (NNRTI) vaginal microbicide product (UC781). The product was evaluated in the context of a Phase I clinical trial in an area characterized by high HIV prevalence among minority women. The findings will inform the development of an acceptable microbicide that will address the needs of diverse women and their partners. Methods: This is a mixed methods study of 34 racially and ethnically diverse female participants and 10 male partners in Atlanta, Georgia. Chi-square tests for marginal homogeneity and kappa statistics were calculated to analyze differences between groups on product attributes and use intention. ANOVA was used to examine difference between the treatment groups. Qualitative data were analyzed via constant comparative methodology. Results: Thirty-four out of the original female cohort of 36 completed the questionnaire. Approval of future microbicide development was high at 91.2% (n=31) despite a lack of enthusiasm for the placebo and UC781 formulations. Overall female acceptability was correlated with personal protection motivation (r=1.00, p<0.001). African American women indicated greater likelihood of post-licensure microbicide use (X2(3)=7.9, p=0.048) and ascribed greater importance to its potential protection against HIV (X2(4)=18.7, p=0.001) and its potential for dual protection (protective against STIs and/or pregnancy) compared to white women (X2(4)=11.3, p=0.024). Men and women supported development in the form of an intravaginal ring or suppository. Men were more likely to encourage female adoption of the method if it afforded HIV protection (r=0.935, p=0.001). Conclusions: Although most women agreed that the development of a microbicide was an important endeavor, quantitative and qualitative data indicated they would not use placebo or UC781 due to the objectionable viscosity, odor, and color. Male partners felt the potential protective benefit of a future microbicide product was its most important feature.

Copyright information:

© 2012 Frew P, et al.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 3.0 Unported License (http://creativecommons.org/licenses/by/3.0/).

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