Women's preferences regarding the formulation of over-the-counter vaginal spermicides.

Objective: There is an urgent need for safe, effective and acceptable vaginal barrier methods for the prevention of sexually transmitted diseases (STDs), including HIV. A variety of existing spermicides have the potential to be used both for prevention of STDs and unwanted pregnancy. Unfortunately, very little is known about formulation preferences and the desirable characteristics of vaginal preparations among the diverse populations of women who would potentially use these products. As product acceptability ultimately determines compliance and use-effectiveness, such information is essential to guide the development and formulation of new microbicidal vaginal products. In this study, we explored vaginal spermicidal preparations containing nonoxynol-9 and the characteristics that influence user preferences for three formulations. We also studied the risk of vaginal and cervical irritation associated with low to moderate use of products containing nonoxynol-9. Methods: One hundred forty-five sexually active women were enrolled in five sites (Côte d'Ivoire, Zimbabwe, USA, and Thailand – two sites: one rural, one urban) and asked to use three different vaginal spermicide preparations containing nonoxynol-9 (a gel, a film, and a suppository). Each volunteer used each product for four weeks. Structured interviews and clinical examinations were conducted at biweekly clinic visits. Prior and to and following product use, women participated in focus group discussions to explore their knowledge, beliefs, and practices surrounding vaginal product use. Results: Women enrolled in the New York City site were almost evenly divided in their preferences of the three formulations; most women enrolled in the Thai sites ranked the film as their preferred formulation (followed by the gel) due largely to the fact that it was easy to use, not too messy, and did not produce a lot of discharge; most of the women enrolled in Zimbabwe also ranked the film as their favorite, followed by the gel, because it was considered the least messy and provided the least amount of lubrication. In Côte d'Ivoire, gel was the preferred formulation, followed closely by film. In general, the suppository was reported to be most messy, with the tendency to melt prior to insertion in hotter climates. No significant irritation or lesions resulted from product use in any of the sites. Almost every woman reported that her partner was aware of, and supportive of, her participation in the study. Conclusion: The formulation preferences of women should be considered in the development and introduction of vaginal microbicides: the specific characteristics of vaginal products and their effect on sexual pleasure and communication will strongly determine the acceptability – and ultimately the use-effectiveness – of female-controlled STD-prevention methods.