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Randomized Controlled Trial
. 2016 Mar 1;62(5):531-6.
doi: 10.1093/cid/civ975. Epub 2015 Nov 26.

Home Screening for Bacterial Vaginosis to Prevent Sexually Transmitted Diseases

Jane R Schwebke  1 , Jeannette Y Lee  2 , Shelly Lensing  2 , Susan S Philip  3 , Harold C Wiesenfeld  4 , Arlene C Seña  5 , Nikole Trainor  3 , Nincoshka Acevado  6 , Lisa Saylor  6 , Ann M Rompalo  7 , Robert L Cook  8
Affiliations
Randomized Controlled Trial

Home Screening for Bacterial Vaginosis to Prevent Sexually Transmitted Diseases

Jane R Schwebke et al. Clin Infect Dis. .

Abstract

Background: Longitudinal studies have consistently found a significant association between bacterial vaginosis (BV) and acquisition of sexually transmitted diseases. However, there are limited prospective data to confirm these findings.

Methods: We conducted a prospective, randomized, open-label trial of home screening and treatment of young women with asymptomatic BV who were also at high risk for sexually transmitted diseases. These women were screened every 2 months for 12 months and randomized to treatment with oral metronidazole 500 mg twice daily for 7 days or observation alone. The primary outcome was the incidence of gonorrhea and/or chlamydia.

Results: A total of 1365 subjects were enrolled in the study across 10 sites. Adherence with mailing specimens obtained at home was excellent in both groups (84%-88%). The incidence of gonorrhea and/or chlamydia was 19.1 per 100 person-years (95% confidence interval, 15.1-22.1) for the treatment group and 18.5 per 100 person-years (15.1-22.8) for the observation arm, a difference that was not statistically significant.

Conclusions: Young women were very amenable to home screening for BV, gonorrhea, and chlamydia. Treatment of asymptomatic BV with 1 week of oral metronidazole did not decrease the incidence of gonorrhea and/or chlamydia.

Clinical trials registration: NCT00667368.

Keywords: STD; bacterial vaginosis; home screening.

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Figures

Figure 1.
Figure 1.
Participant flow. BV, bacterial vaginosis.
Figure 2.
Figure 2.
Adherence to kit collection.
Figure 3.
Figure 3.
Acquisition, recurrence, and persistence of bacterial vaginosis (BV).
See this image and copyright information in PMC

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