None listed
Conditions
Brief summary
Current first-line antibiotic therapies for bacterial vaginosis (BV) provide cure rates of 70-80% 1 month after treatment, but >50% experience BV recurrence within 3-6 months of completing recommended treatment. There is epidemiological and microbiological evidence supporting sexual exchange of vaginal bacteria (both optimal and non-optimal) between sexual partners. BV imposes a heavy burden on the healthcare system, as recurrence results in multiple presentations to clinical services and repeated antibiotic use. In addition, the obstetric and reproductive sequelae associated with BV have significant implications for healthcare expenditure. Effective therapeutic approaches are an urgent health priority. The LGBTQIA+ community have a higher prevalence of BV in many settings. Given the evidence of sexual exchange of bacteria between partners, treatment of only one individual in a partnership may result in re-infection when sex resumes post-treatment. Given the high rate of BV in the LGBTQIA+ community, we hypothesise that treating the regular sexual partner of people diagnosed with BV (the index) will reduce BV recurrence. All couples will have access to treatment which will be anatomically directed. We aim to recruit 74 couples (148 individuals) in Australia, and we are using single-arm design, where if both individuals have a vagina, they will both be offered first-line therapy with oral metronidazole. There is also provision for couples where a partner decides not to receive treatment, or has anatomy requiring combination-therapy. We will collect genital, oral and anal specimens from all participants before and after treatment, and then weekly for up to 9 weeks to see if the index gets their BV back again or not.
Interventions
The PACT study is a partner-treatment study for monogamous couples who are in the LGBTQIA+ community, where one person has a vagina and is diagnosed with bacterial vaginosis (BV) and their partner, regardless of their genitals or their gender identity (excluding cisgender-men). All couples will receive anatomically directed treatment. The principal study population includes couples where both have a vagina and both receive treatment.
Treatment:
Individuals with a vagina: (regardless of how they
The PACT study is a partner-treatment study for monogamous couples who are in the LGBTQIA+ community, where one person has a vagina and is diagnosed with bacterial vaginosis (BV) and their partner, regardless of their genitals or their gender identity (excluding cisgender-men). All couples will receive anatomically directed treatment. The principal study population includes couples where both have a vagina and both receive treatment. Treatment: Individuals with a vagina: (regardless of how they identify) will receive monotherapy with oral metronidazole (a 400mg oral tablet twice daily for 7 days). Where an individual has a contraindication or allergy to metronidazole, they will receive monotherapy with clindamycin cream (2% intravaginal pessary for 7 nights). The following provisions will be made for other couples where the index receives the treatment above: • Partner with a vagina who does not have BV and declines treatment; The couples will still be followed for 9 weeks and asked to self-collect specimens and complete questionnaires. This sub-group will be able to access treatment at a later time point if they request it. • Partner with a penis; The participant will receive oral metronidazole 400mg twice daily and topical 2% clindamycin cream to be applied to the glans penis (under the foreskin if uncircumcised) and upper shaft twice daily (morning and night) for 7 days. • Partner with a neovagina; The participant will receive oral metronidazole 400mg twice daily and topical 2% intravaginal clindamycin cream once a day at night for 7 nights. • Partner with a vagina taking testosterone; The participant will receive antibiotics with partner as randomised above. All participants will be sent an SMS the day after they are due to finish treatment which will ask about their adherence to the treatment/s they received.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Index participants will be eligible if they are: i) Are diagnosed with BV ii) Aged 18 years to pre-menopausal (i.e. not more than 12 consecutive months after the last menstrual period/menopause) iii) Have an partner who meets the study criteria iv) Sufficient English to understand study procedures v) Provide written informed consent and is willing to comply with study procedures vi) Able to complete study protocol requirements The partner will be eligible if they: i) Have an partner (the index) who has been diagnosed with BV (they do not need to have a BV diagnosis as well) ii) Are aged 18 years or older iii) For partners of an index who attended clinic: enrol within 3 business days of their partner being diagnosed with BV (or the index agrees to waits before starting treatment so that couples are aligned with therapy) iv) For partners at home: return baseline procedures/screening packs to determine BV-status if applicable v) Have sufficient English to understand study procedures vi) Provide written informed consent and is willing to comply with study procedures vii) Able to complete study protocol requirements
Exclusion criteria
Participants will be ineligible if they: i) Are confirmed to be pregnant or breastfeeding, or planning to conceive in the next 9 weeks ii) Are unwilling or unable to comply with the requirements of the study protocol iii) Have other concurrent sexual partners iv) Are a current sex worker v) Have an allergy or contraindication to both first-line antibiotics for BV, metronidazole, and clindamycin vi) Have taken metronidazole or clindamycin in the 2 weeks prior to enrolment vii) Are being prescribed 14 days of metronidazole for PID treatment Additionally, the partner will be ineligible if they: i) Identify as a cis-gender male and have a cis-gender female partner (heterosexual couples will be offered participation in Step Up RCT, ANZCTR: ACTRN12619000196145 ) ii) Had metronidazole in the week prior to enrolment or are being prescribed 14d of metronidazole for PID treatment iii) Has a contraindication/allergy that means they cannot receive treatment
Outcome results
None listed