Bacterial Vaginosis Home Screening to Prevent STDs
Status:
Completed
Trial end date:
2014-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)