About Bacterial Vaginosis
Bacterial vaginosis (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.
Current recommended treatment for BV is with oral or vaginal antibiotics. Studies have shown that while these treatments cure 70-80% of women within a month, 1 in 2 women will get their BV back again within 6 months of treatment.
We hypothesise that reinfection from sexual partners may be contributing to the high rates of women getting BV again after treatment. This hypothesis is supported by studies that have shown that women who have the same male sex partner before and after being treated for their BV are more likely to get their BV back again and inconsistent condom use is associated with BV recurrence. In addition, a number of investigators have shown that BV-associated bacteria are present in male partners of women with BV on the penile skin and also at the end of the urethra.
Currently, male partner treatment is not part of the treatment guidelines for BV. We have received funding from the Australian government to investigate whether treating male partners of women with BV prevents their BV from coming back. We are also interested in learning more about how treating both the female and her male partner impacts the BV-associated bacteria present on the genitals.
All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been approved by the HREC of the Alfred Hospital.
This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies. Approval has been given by the Alfred Hospital HREC which reviews ethics applications for research carried out at the Melbourne Sexual Health Centre.
‘Step Up’ is a study aiming to determine whether the treatment of male partners of women being treated for BV reduces women getting their BV back again.
We are looking for women who have BV and who have a regular male partner who would be interested in participating in the study. Male partners will be randomised into one of two study groups. Males will either be given treatment to take at the same time as their female partner, or no treatment. We will ask couples to self-collect genital samples and complete a questionnaire monthly for 3 months.
• Research Study Site Melbourne Sexual Health Centre
• Principal Investigators Associate Professor Catriona Bradshaw & Dr Lenka Vodstrcil
• Associate Investigators Prof Christopher Fairley, Prof Jane Hocking, Michelle Doyle, Marti Kaiser, Erica Plummer, Dr Gerald Murray, A/Professor Kathy Petoumenos, Prof Matthew Law
We are recruiting heterosexual couples where the female has BV, both you and your male partner will be asked to participate.
You will be asked to come to the Melbourne Sexual Health Centre for an appointment to confirm you have BV. After being diagnosed with BV, you will receive the normal antibiotic treatment from the doctor. You can then meet with a research nurse who will explain the study to you and assess if you are eligible. If you are eligible the research nurse will contact your partner. If your partner is eligible and wants to take part in the study he will be asked to consent to being put into one of two study groups.
The ‘Step Up’ study is a randomised controlled research project. This means that we put people into groups and give each group different treatment. This is important so that we can compare the results of the different treatments to see if one is better than the other. To try to make sure the groups are the same, each participant is put into a group by chance (random). In this study, it is the male partner who will be randomly put into one of the two groups. He will either be given treatment to take at the same time as you, or no treatment. The treatment group involves taking an oral antibiotic and using a topical antibiotic cream applied twice daily to the penile skin for one week at the same time as you are undergoing treatment for BV.
We will ask you and your partner to self-collect genital samples and complete a short questionnaire before you start taking the antibiotics, when you finish your antibiotics and at monthly intervals over the next 3 months. For men this is simply a urine sample and cotton-tipped swab from the skin on the head of the penis and for women this is a self-collected vaginal swab. Clear instructions and reminders will be provided throughout the study. We will use these samples to understand how bacteria associated with BV on the genitals respond to antibiotic treatment. Females will be asked to attend the clinic for review at the 1 month point, and at 3 months for a final review appointment. Appointments can be made at a time and date that suits you. You can also be reviewed in the clinic throughout the study period should you have any concerns or if your BV comes back again.
Participation in this research is voluntary and there will be plenty of opportunities to ask questions. You can call 03 9341 6244 to speak to a research nurse anytime during business hours throughout the study.
You and your partner will be reimbursed for the time you spend participating in this study.
We are a group of researchers and clinicians working in the field of sexual health at Monash University, The University of Melbourne and Alfred Health.
We specialise in bacterial vaginosis and sexually transmitted infection research.
iSpy STI is a website produced by analysing thousands of clinical case presentations from the Melbourne Sexual Health Centre to provide an easy to use, sexual health symptom checker for people who may have a sexually transmitted infection (STI).