Partner Cohort Treatment Study (PACT study) for bacterial vaginosis

Phase 3

Recruiting

• Conditions: bacterial vaginosis; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Infection - Other infectious diseases; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12622001431718
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-08
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified