HIV/AIDS Bacterial Vaginosis
Conditions
Interventions
Cyclic CVR use
Non cyclic CVR use
Sponsors
University of Washington
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female Eligibility Criteria: =18-40-year-old BV+ by Amsel’s criteria Not intending or wishing to become pregnant over the course of the study Capable of providing written informed consent Male Eligibility Criteria: Main sex partner of the randomized female participant Capable of providing written informed consent
Exclusion criteria
Exclusion criteria: Female Exclusion Criteria: Current pregnancy Desire/intent to become pregnant over the course of the study Current cigarette smoking if age is older than 35 years Unable to comprehend consent material because of the language barrier or psychological difficulty Male Exclusion Criteria: Unable to comprehend consent material because of the language barrier or psychological difficulty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome 1: Quantity of L. crispatus determined by species-specific qPCR assay Outcome 2: Local immune parameters, including cytokines, innate mediators, and functional antimicrobial activity in cervicovaginal secretions as assessed by anti-E. coli, anti-HSV, and anti-HIV activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantity of genital HIV shedding among HIV-infected participants | — |
Countries
Kenya
Contacts
Public ContactElizabeth Irungu
Study Physician
Outcome results
None listed