Pilot study to determine the acceptability and tolerability of male partner treatment in women with bacterial vaginosis (BV) - stage 2

Phase 2

Completed

• Conditions: Bacterial vaginosis; Infection - Sexually transmitted infections; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12618000219280
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-09
• Study Completion: 2019-06-06
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Women will be eligible if they:
1. are 18-55 years of age
2. have symptomatic BV, microbiologically defined as a Nugent score of 4-10 and 3-4 Amsel criteria,
3. are willing and able to comply with protocol requirements
4. have a regular male partner who is willing to be enrolled in the trial
5. must have been in a relationship with their regular male partner for at least two months at the time of enrolment

Men will be eligible if:
1. their regular female partner meets the eligibility criteria
2. they are willing and able to comply with protocol requirements, which includes enrolling within a week of their partner

Exclusion Criteria

Women will be ineligible if they:
1. are HIV positive
2. are pregnant or breast feeding
3. are diagnosed with current PID
4. have an allergy to both first line antibiotics for BV, metronidazole and clindamycin
5. test positive for C.trachomatis, N.gonorrhoeae or T.vaginalis at baseline
6. have other current sexual partners
7. are a current sex worker

Men will be ineligible if they:
1. report a drug allergy to metronidazole or clindamycin,
2. are HIV positive
3. have other current sexual partners
4. are a current sex worker

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the acceptability and tolerability of male partner treatment in women with BV. This is a composite primary outcome. Participants will self-report adherence to treatment and any side effects (e.g. nausea, headache, skin irritation, rash, vomiting) experienced at day 8. These data will be used as a measure of acceptability and tolerability of treatment.[Day 8 - at the end of treatment period]

Secondary Outcome Measures

Name	Time	Method
To determine if dual partner treatment (both the female and the male) for BV is associated with a sustained reduction in load of key BV-associated bacteria (BVAB) in the male and female genital tract over four months following treatment <br><br>The genital microbiota will be characterized using 16S rRNA gene sequencing. Changes in the composition of the genital microbiota will be assessed using Bray-Curtis scores. Changes in bacterial diversity (calculated using the Shannon diversity index) as well as changes in the abundance and prevalence of specific bacteria will be measured. [Baseline (day 0) and 3 months from baseline]