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

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.

HIV Risk Characteristics Associated with Violence Against Women: A Longitudinal Study Among Women in the United States

“…[49][50][51][52] Despite mixed efficacy findings for products such as tenofovir gel 53,54 and the Phase III randomized placebocontrolled FEM-PrEP clinical trial of a daily oral dose of tenofovir disoproxil fumarate and emtricitabine, 55 microbicides may offer additional HIV prevention options for women with strong acceptability. [56][57][58] Yet, there remains a challenge to educate and offer PrEP to women experiencing violence.…”