Bacterial vaginosis (BV) is a common vaginal condition among women which often comes back even after antibiotic treatment. We believe that reinfection from sexual partners may be contributing to the high rates of women getting BV again.
What is StepUp?
StepUp is a research study in Victoria and New South Wales aiming to determine the effectiveness of treating the male partners of women with BV to prevent women getting their BV back again.
StepUp is being conducted by researchers from Victoria and New South Wales and has been approved by the Alfred Hospital Ethics Committee. You will be reimbursed for the time you spend participating in this study.
If you have BV and have a regular male partner, we would love to hear from you!
Are you eligible to participate?
Complete our online survey to see if you are eligible to join Step Up
About BV
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.
BV can be associated with important complications such as:
- miscarriage
- premature birth
- low birth weight
- pelvic infection
- increased risk of HIV and sexually transmissible infections
Current recommended treatment for BV is 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.
About the study
StepUp is a study aiming to determine whether the treatment of male partners of heterosexual women being treated for BV reduces women getting their BV back again.
We believe 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.
What are we investigating?
Currently, male partner treatment is not part of the BV treatment guidelines.
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 woman and her male partner impacts the BV-associated bacteria present on the genitals.
Current recommended treatments have good short-term effect but 1 in 2 women experience reoccurring BV within 6 months of treatment. BV bacteria are often found in male partners of women with BV and could be reinfecting women with BV bacteria.
This study aims to determine if treating women with BV and their regular male partners will prevent BV reoccurring in the female partners. Women with BV and their regular male partner will be asked to take part in the study.
Ethics
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 Alfred Hospital HREC.
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.
Who can participate in this study?
Currently we are looking for:
- heterosexual couples where the female has BV
- couples who are in a monogamous relationship (no other current sexual partners)
- couples who are currently living in Melbourne, Sydney or Adelaide for the next three month. We follow couples for 3 months to see if your BV returns
A more inclusive study for any couples where at least one person has BV is coming soon!
What's involved
- 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 StepUp study is a randomised controlled research project.
What is a randomised controlled research project?
Randomised controlled research means that we put people into groups and give each group different treatment. We do this so 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.
What treatment will my partner take?
The treatment group will take 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.
What else is involved?
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 a urine sample and cotton-tipped swab from the skin on the head of the penis
- For women, this is a self-collected vaginal swab
Clear instructions and reminders will be provided throughout the study.
What are the samples used for?
We will use these samples to understand how bacteria associated with BV on the genitals responds to antibiotic treatment. Women will be asked to attend the clinic for review at the one 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.
What if I have questions?
Participation in this research is voluntary and there will be plenty of opportunities to ask questions. You can call us 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.
This research study is being completed at Melbourne Sexual Health Centre.
Researchers
Principal investigators
Associate investigators
Research nurses
Partners
Publications
A prospective, open-label pilot study of concurrent male partner treatment for bacterial vaginosis
Plummer EL, Vodstrcil LA, Doyle M, Danielewski JA, Murray GL, Fehler G, Fairley CK, Bulach DM, Garland SM, Chow EPF, Hocking JS, Bradshaw CS.
(2021), mBio,
Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence
Vodstrcil LA, Plummer EL, Doyle M, Fairley CK, McGuiness C, Bateson D, Hocking JS, Law MG, Petoumenos K, Donovan B, Chow EPF, Bradshaw CS
(2020), BMC Infectious Diseases: 20(1); 834,
Combined oral and topical antimicrobial therapy for male partners of women with bacterial vaginosis: tolerability, acceptability and impact on the genital microbiota of couples
Plummer EL, Vodstrcil LA, Danielewski JA, Murray GL, Fairley CK, Garland SM, Hocking JS, Tabrizi SN, Bradshaw CS
(2018), PLOS ONE,