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Bacterial vaginosis home screening does not influence gonorrhea, chlamydia
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Despite high levels of compliance, home screening for bacterial vaginosis and its subsequent treatment did not reduce the incidence of gonorrhea or chlamydia in adolescent and young women, according to a recently published study.
“Although [bacterial vaginosis (BV)] may cause symptoms of vaginal discharge and odor, a significant number of women are asymptomatic,” the researchers wrote. “BV is significantly associated with acquisition of STDs including chlamydia and gonorrhea, however, there have been few published clinical trials to determine whether screening and treatment of asymptomatic BV will reduce the risk.”
In the randomized study, the researchers enrolled women aged 15 to 25 years with asymptomatic BV from 10 clinical sites throughout the United States. Qualifying participants reported vaginal intercourse within the past 3 months, and they had multiple risk factors for STDs. The women were provided an oral, twice-daily regimen of 500 mg metronidazole for 7 days and regularly delivered home testing kits, which they were instructed to use and return through the mail for clinical testing. Participants randomly assigned to the treatment group were informed of their results and received another regimen of metronidazole; control group participants did not receive notification or treatment. Researchers gave participants questionnaires at baseline to assess demographics, risk behavior and health history, with additional surveys distributed along with testing kits. The primary endpoint was incidence of chlamydia and gonorrhea among each study group.
There were 1,370 women enrolled, 993 of whom completed the study and were included in the final analysis; however, data from all evaluable visits were included in the intention to treat analysis. The early discontinuation or loss to follow-up rate was 25% for the treatment group and 29% for the observation arm, with discontinuation associated with younger age (P = .044) and positive STD status at baseline (P = .004).
The researchers reported the incidence rate of gonorrhea or chlamydia at 1 year to be 18.3 per 100 person-years (95% CI, 15.1-22.1) for women receiving test results and treatment, and 19.2 per 100 person-years (95% CI, 15.9-23.2) for those who did not. Similar results were seen when analyzing the cumulative proportion of participants with gonorrhea or chlamydia at the same bench mark, but the researchers did observe fewer follow-up BV diagnoses in the treatment group than in the control group (OR = 0.53; 95% CI, 0.46-0.61). Although a greater number of serious adverse events occurred in the treatment arm (9 vs. 3), none was associated with the use of metronidazole.
“This is the largest study to ever evaluate the impact of treatment of BV on STD outcomes and demonstrated that women were very compliant with the submission of self-collected vaginal specimens mailed on an every 2-month schedule,” the researchers wrote. “However, based on this study, treatment of asymptomatic BV with oral metronidazole does not impact the incidence of gonorrhea or chlamydia. If more effective therapies for BV become available consideration should be given to revisiting this approach.” – by Dave Muoio
Disclosure: The researchers report no relevant financial disclosures.
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