Acceptability of a novel vaginal microbicide during a safety trial among low-risk women

Context: The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV , has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, cl inical trials generally overlook another key factor in a product's impact o n infection rates-its acceptability to users. Methods: A Phase I clinical trial of a microbicidal gel included an assessm ent of the product's acceptability among 27 low-risk participants. Informat ion on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews. Results: Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel Some women noted product discharg e and messiness as drawbacks of the method, but this experience varied acco rding to how often the women applied the gel. For example, one-third of tho se who used it once daily said that at least some of the time, it was too " wet or drippy," compared with two-thirds of women who inserted the gel twic e a day. However, participants considered these "nuisance factors" that cou ld be outweighed by the potential protective characteristics of the product . The majority reported that they would use the product if it were availabl e and proven efficacious, and if they perceived that they were at risk of S TD infection. Conclusions: Additional testing of this product is urgently needed. Further more, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.