Pilot study to determine the acceptability and tolerability of male partner treatment in women with bacterial vaginosis (BV) - stage 2

OVERALL AIM: This study aims to determine the feasibility and acceptability of treatment of male partners of women with bacterial vaginosis (BV). OTHER AIMS: To examine the impact of dual partner treatment (male and female treatment) for BV on BV-associated bacteria on the male and female genitalia for 3 months after treatment. BACKGROUND AND SIGNIFICANCE: BV is the most common cause of abnormal vaginal discharge in women of reproductive age affecting between 12-30% of women, suggesting it may currently affect at least 1 million Australian women. It can be associated with important complications such as miscarriage, premature birth, low birth weight, pelvic infection, and increased risk of HIV and sexually transmitted infections. We have shown that BV recurrence (getting the infection back again) in women is common even after they have taken the recommended antibiotic treatment. A number of investigators have shown that BV-associated bacteria (BVAB) are present in male partners of women with BV on the penile skin and at the end of the urethra, but men have no symptoms of BV and male partner treatment is not currently recommended by current treatment guidelines. Studies of recurrent BV indicate that reinfection from sexual partners may be contributing to the high rates of recurrence but this requires more evaluation. Metronidazole and topical clindamycin are both antibiotics approved for use in Australia to treat BV in women. As BV has not previously been thought to affect men they have not been licensed for use to treat BV in men. Clindamycin cream and oral metronidazole are therefore considered is an experimental treatment for BV in men. This means that they are being tested to see if they are an effective treatment to get rid of BV-associated bacteria in men. There are two treatment groups in this study. Participants will be given the opportunity to choose what group to participate in, providing the maximum number of participants allowed in that group has not been reached. 1. Dual partner treatment – both the female and her male partner will receive antibiotic treatment. 2. Female only treatment (maximum of 10 couples can participate) – only the female will receive antibiotic treatment. Her male partner will not be asked to take any antibiotics.