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Trial registered on ANZCTR


Registration number
ACTRN12622001431718
Ethics application status
Approved
Date submitted
18/10/2022
Date registered
8/11/2022
Date last updated
22/11/2024
Date data sharing statement initially provided
8/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Partner Cohort Treatment Study (PACT study) for bacterial vaginosis
Scientific title
A pilot randomised Partner Cohort Treatment Study for monogamous couples who are in the LGBTQIA+ community, where one person has bacterial vaginosis
Secondary ID [1] 306833 0
none
Universal Trial Number (UTN)
U1111-1284-0518
Trial acronym
BV PACT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bacterial vaginosis 325918 0
Condition category
Condition code
Infection 323232 323232 0 0
Other infectious diseases
Renal and Urogenital 325059 325059 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 325060 325060 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324657 0
Treatment: Drugs
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332834 0
The acceptability, tolerability and adherence to concurrent partner treatment (whole population) as a composite outcome.
Adherence and tolerability will be assessed by audit of participant questionnaire designed specifically for this study and to be filled-out the day after treatment is expected to be completed (i.e. day 8). Acceptability will be assessed by audit of participation in the trial by partners of an index with bacterial vaginosis diagnosed - i.e. proportion of index BV participants whose partners received treatment.
Timepoint [1] 332834 0
Adherence tolerability and acceptability will be assessed at day 8 post-intervention commencement
Primary outcome [2] 332836 0
Establish the effect of both treatment strategies on the genital microbiota of couples using genomic sequencing of genital swabs.
Timepoint [2] 332836 0
This will be assessed at baseline, and day 8 as well as weekly for 9 weeks post-treatment commencement. All specimens will be included.
Secondary outcome [1] 414817 0
1) BV recurrence within 9 weeks of treatment in all study populations. This will be assessed using vaginal smears provided each week by participants, which will undergo Nugent scoring by an experienced microscopist. Two sequential Nugent scores of 7-10 will indicate BV.
Timepoint [1] 414817 0
Recurrence will be assessed weekly for 9 weeks post-treatment commencement
Secondary outcome [2] 414818 0
2) BV recurrence within 4 weeks of treatment in all study populations. BV will be assessed using vaginal smears provided each week by participants, which will undergo Nugent scoring by an experienced microscopist. Two sequential Nugent scores of 7-10 will indicate BV.
Timepoint [2] 414818 0
Recurrence will be assessed weekly for 4 weeks post-treatment commencement
Secondary outcome [3] 414819 0
3) BV recurrence within 9 weeks of treatment. BV will be assessed using vaginal smears provided each week by participants, which will undergo Nugent scoring by an experienced microscopist. Two sequential Nugent scores of 7-10 will indicate BV, or BV may be clinically diagnosed if the participant attends clinic. The findings will be used to generate recurrence rates and confidence intervals.
Timepoint [3] 414819 0
Recurrence will be assessed weekly for 9 weeks post-treatment commencement
Secondary outcome [4] 414822 0
6) The effect of concurrent partner treatment on the oral microbiome of couples over 9 weeks (including oral specimens from both the index with BV at enrolment and partner), using genomic sequencing of saliva samples.
Timepoint [4] 414822 0
This will be assessed at baseline, and day 8 as well as weekly for 9 weeks post-treatment commencement. All oral specimens will be included.
Secondary outcome [5] 414983 0
7) The effect of concurrent partner treatment on the gut microbiome of couples over 9 weeks (including specimens from both the index with BV at enrolment and partner), using genomic sequencing of rectal swabs.
Timepoint [5] 414983 0
This will be assessed at baseline, and day 8 as well as weekly for 9 weeks post-treatment commencement. All rectal swab specimens will be included.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All couples will be offered treatment with metronidazole (monotherapy), unless they require genital-directed treatment or have a contraindication (these couples will receive the treatment they can tolerate or that is appropriate for their genitals).

If a protocol violation occurs after randomisation (defined above), reasons will be collected, and the participant will be deemed either lost to follow up or withdrawal if this is formally what they decide to do. Couples who fail screening will not be included in the evaluable population for analyses and we will recruit an additional couple.

Rescue therapy for couples where one or both have BV recurrence
All participants who are diagnosed with BV recurrence during the study period will be offered a consultation (either face to face at MSHC or over the phone) and offered concurrent partner treatment with combination-therapy (with both metronidazole and intravaginal clindamycin). Participants will complete a post-antibiotic (day 8) pack and then continue to provide samples for the 9-week follow-up period, or until 4-weeks post initiating combination therapy, whichever option captures at least 4-weeks post-treatment.



Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis of primary and secondary outcomes
Data will be transferred to STATA for analysis. Kaplan Meier methods will be used to generate survival curves for time until recurrence of BV for index participants and to abnormal microbiota (i.e. a genital microbiota dominated by BV-associated bacteria). Recurrence rates and their 95% CI will be calculated for all treated couples, regardless of treatment. Additional risk factors associated with recurrence of BV will be investigated using Cox regression. Rate ratios and robust standard errors will be calculated using this methodology.

We will generate efficacy estimates with 95%CIs that will be able to be compared to historical BV recurrence estimates.

Microbiota analysis
The exact methods used are to be determined, but all microbiota analysis will be conducted with the aim of characterising the genital, oral and gut microbiota, and will be conducted on samples that are coded with a unique identifier, date of birth and date of collection only.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/10/2023
Actual
9/01/2024
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
148
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 23378 0
Melbourne Sexual Health Centre (MSHC) - Carlton
Recruitment postcode(s) [1] 38775 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 311163 0
Government body
Name [1] 311163 0
National Health and Medical Research Council Australia
Country [1] 311163 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 1, Chancellery Building D
26 Sports Walk, Clayton Campus, Wellington Rd
Clayton 3800
VIC
Country
Australia
Secondary sponsor category [1] 314083 0
None
Name [1] 314083 0
Address [1] 314083 0
Country [1] 314083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310693 0
Alfred Hospital HREC
Ethics committee address [1] 310693 0
Ethics committee country [1] 310693 0
Australia
Date submitted for ethics approval [1] 310693 0
22/08/2022
Approval date [1] 310693 0
18/10/2022
Ethics approval number [1] 310693 0
456/22
Ethics committee name [2] 313958 0
ACON Ethics Committee
Ethics committee address [2] 313958 0
Ethics committee country [2] 313958 0
Australia
Date submitted for ethics approval [2] 313958 0
27/04/2023
Approval date [2] 313958 0
02/06/2023
Ethics approval number [2] 313958 0
202309

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118534 0
Prof Catriona Bradshaw
Address 118534 0
Melbourne Sexual Health Centre
580 Swanston St
Carlton 3053
VIC
Country 118534 0
Australia
Phone 118534 0
+61 3 93416253
Fax 118534 0
Email 118534 0
catriona.bradshaw@monash.edu
Contact person for public queries
Name 118535 0
Lenka Vodstrcil
Address 118535 0
Melbourne Sexual Health Centre
580 Swanston St
Carlton 3053
VIC
Country 118535 0
Australia
Phone 118535 0
+61 3 93416200
Fax 118535 0
Email 118535 0
stopbv@mshc.org.au
Contact person for scientific queries
Name 118536 0
Lenka Vodstrcil
Address 118536 0
Melbourne Sexual Health Centre
580 Swanston St
Carlton 3053
VIC
Country 118536 0
Australia
Phone 118536 0
+61 3 93416200
Fax 118536 0
Email 118536 0
stopbv@mshc.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Sequencing data with info specific to bacterial sequences will be publically available. If publishers require meta-data to be uploaded to accompany any related publications, only de-identified data of published results that is not able to be linked to any individual would be considered for data sharing, in alignment with the NHMRC statement. New ID codes would be assigned to any data to be shared.
When will data be available (start and end dates)?
From the publication date for 5 years after publication
Available to whom?
Microbiota data would be publicly available
Other meta-data would be considered by request
Available for what types of analyses?
The data would be available for microbiota analysis.
Additional data sharing may be considered for meta-analyses (however only de-identified pooled data).
How or where can data be obtained?
Any laboratory/microbiota sequencing data will be made publicly available on a repository such as Short Read Archive (SRA) as is standard practice.
Other meta-data may be uploaded with a manuscript as required by the publisher.
Additional data requests can be made to the contact author listed on any publication catriona.bradshaw@monash.edu


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17390Study protocol    We aim to publish the study protocol. It will outl... [More Details]
24299Other https://www.mshc.org.au/research/research-studies/pact-study  Study website and link to Expression of Interest f... [More Details]



Results publications and other study-related documents

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