A pilot randomised Partner Cohort Treatment Study for monogamous couples who are in the LGBTQIA+ community, where one person has bacterial vaginosis

Monash University0 个研究点目标入组 148 人开始时间: 2022年11月8日最近更新: 2023年10月16日

适应症

试验速览

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•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

•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

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