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
Outcome
Missed primary endpoint
registry Control vs Intervention; p = 0.754; Risk Difference (RD) -0.9 (95% CI -12.0 to 10.1) NCT00667368 ↗
paper Treatment of asymptomatic BV with 1 week of oral metronidazole did not decrease the incidence of gonorrhea and/or chlamydia. PMID 26611782 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metronidazole | Small molecule | 500 mg | Oral |