Bacterial Vaginosis Home Screening to Prevent STDs

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.

Timeline

Start

2008-07-28

Primary completion

2014-12-31

Completion

2014-12-31

Publications

• Schwebke JR, Lee JY, Lensing S, Philip SS, Wiesenfeld HC, Sena AC, Trainor N, Acevado N, Saylor L, Rompalo AM, Cook RL. Home Screening for Bacterial Vaginosis to Prevent Sexually Transmitted Diseases. Clin Infect Dis. 2016 Mar 1;62(5):531-6. doi: 10.1093/cid/civ975. Epub 2015 Nov 26.

Drugs

Indications