Bacterial vaginosis (BV) is a common vaginal condition among women and people with a vagina 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 the PACT study?
The PACT Study is a research project in Australia that is investigating a new treatment for BV which involves treating both the person with BV and their partner with antibiotics at the same time. It is focused on monogamous couples who identify as being in the LGBTQIA+ community. (For our alternative study for heterosexual couples called Step Up - please click HERE).
PACT 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.
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 cause distress to affected individuals and 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
The PACT study is a study aiming to determine whether the treatment of the regular sexual partners of people being treated for BV reduces the chance of people getting their BV back again. It is focused on monogamous couples who identify as being in the LGBTQIA+ community.
We believe that reinfection from sexual partners may be contributing to the high rates of people getting BV again after treatment.
This hypothesis is supported by studies that have shown that women and people with a vagina who have the same sex partner before and after being treated for their BV are more likely to get their BV back again. In addition, a number of investigators have shown that BV associated bacteria are shared between couples.
What are we investigating?
Currently, sexual partners of people diagnosed with BV do not receive any treatment as part of BV treatment guidelines.
We have funding from the Australian government to investigate if treating both the person with BV and their partner with antibiotics at the same time impacts on BV cure outcomes. We are also interested in learning more about how treating couples impacts on BV-associated bacteria present in genitals.
This study aims to treat both people in the monogamous couple where one or both have BV with antibiotics at the same time. Couples where both have a vagina will be randomised to both receiving mono-therapy or combination-therapy; others will receive anatomically-directed antibiotic treatment.
The aims of the study are to: 1) Determine the acceptability of partner treatment among couples from the LGBTQIA+ community; 2) Generate data on the tolerability and adherence of monotherapy (oral metronidazole only) vs combination-therapy (oral metronidazole and topical clindamycin) to inform a larger double-blinded RCT; 3) Establish the effect of both treatment strategies on the genital microbiota of couples.
Find out more about this clinical trial at the ANZCTR (LINK PENDING)
Who can participate in this study?
Currently we are looking for:
- Couples who identify as part of the LGBTQIA+ community where at least one person has BV
- Couples who are in a monogamous relationship (no other current sexual partners)
- Couples who live in Australia.
What’s involved
If you or your partner have BV symptoms (a fishy-smelling vaginal discharge) you can call us or email us to discuss with the research team options for participation.
You can either attend the Melbourne Sexual Health Centre if convenient for you to undergo a genital examination by a research nurse or doctor, or you can contact us and we can send you a screening pack. When you call us to either make an appointment or to request a screening pack the research team will briefly explain the trial to you and check that you are eligible to participate.
What happens when you are diagnosed with BV?
If you and/or your partner are diagnosed with BV, the research team will then discuss with you the options for treatment and further explain the study to you in more detail.
If you are both willing and eligible to participate, the research team will provide you with participant information sheets and consent forms.
If you do not wish to participate, or your partner does not want to participate, your clinical care or any future visit to the Melbourne Sexual Health Centre will not be affected.
What is a randomised research project?
Randomised 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, Most couples will be randomly allocated one of the following groups:
Group 1 Monotherapy (Half of the couples): If you are in this group both you and your partner will receive oral metronidazole twice a day for 7 days.
Group 2 Combination therapy (Half of the couples): If you are in this group both you and your partner will receive oral metronidazole twice daily for 7 days AND intravaginal clindamycin 2% cream twice daily for 7 days.
If you and/or your partner has allergies or cannot tolerate metronidazole, you and your partner will both receive monotherapy with intravaginal clindamycin 2% cream twice daily for 7 days.
If you and/or your partner has allergies or contraindications to clindamycin, you and your partner will both receive monotherapy with oral metronidazole twice daily for 7 days.
If one of you does not have a vagina, you will both be given the same treatment which will be determined based on both of your genitals.
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 weekly intervals over the next 2 months:
- For people with a vagina, this is a self-collected vaginal sample
- For people who have undergone gender-affirming surgery and have a vagina, this is a urine sample and a self-collected vaginal sample
- For people with a penis, this is a urine sample and cotton-tipped swab from the skin on the head of the penis
- For all people –additional samples include an oral swab and optional self-collected rectal 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 respond to antibiotic treatment. The oral and gut samples will be used at the end of the study to see how the bacteria present in the genitals and mouth respond to antibiotic treatment. The rectal samples will be used to see how the gut microbiome is affected by BV-treatment, and if the gut microbiome contains BV-causing bacteria
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.