At a glance
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Home Screening for Bacterial Vaginosis to Prevent STDs
In Brief
A Phase 3 clinical trial evaluating Metronidazole for Bacterial Vaginosis. Completed, enrolled 1,370 participants across 7 sites.
Detailed Summary
The purpose of this study is to determine whether regular screening (every 2 months) and treatment for bacterial vaginosis (BV \[infection of the vagina\]) will reduce the number of incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a year. Chlamydial and gonococcal infections will be determined by vaginal swab testing at 4, 8, and 12 months after enrollment. Subjects will include 1500 women aged 15-25 years who have clinical evidence of BV, with no symptoms. Subjects will be randomly assigned to 1 of 2 possible study groups: the intervention group (treatment of BV) or the control group (no BV treatment). Every 2 months, subjects will complete a home self-testing kit for screening of BV using a swab. If BV is detected by self-test, the subjects in the interventional group will receive a 7 day course of the antibiotic metronidazole. Participants will be involved in study related procedures for up to 12 months.
Study Details
Timeline
Interventions
Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.