CLINICAL RESEARCH UPDATE

by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer

March 11, 2025


Featured Literature:

Vodstrcil LA, Plummer EL, Fairley CK, et al. for the StepUp Team. Male-partner treatment to prevent recurrence of bacterial vaginosis. N Engl J Med. 2025 Mar 6:392(10):947-957. doi: 10.1056/NEJMoa2405404.

This study describes results of a randomized open-label trial assessing whether partner therapy using concurrent oral and topical antimicrobial treatment decreased 3-month bacterial vaginosis (BV) recurrence compared to standard of care. Symptomatic premenopausal women (with a single regular male partner) who met diagnostic criteria and were receiving first-line treatment (e.g., metronidazole twice daily for 7 days, intravaginal clindamycin for 7 nights, or intravaginal metronidazole for 5 nights) were enrolled from sexual health and family planning clinics in Australia. Male partners in the intervention group received metronidazole 400mg (taken 2x/day for 7 days) and 2% clindamycin cream (applied 2x/day for 7 days). BV recurrence was observed in 24/69 (35%) in the intervention group compared with 43/68 (63%) in the control group, with a recurrence rate of 1.6 vs. 4.2 per person-year. When stratified by IUD use and circumcision status, there was no evidence of different treatment effects. Sensitivity analyses indicated that recurrence was lowest among partners of men who were 100% adherent to treatment medications. Adverse events were reported among 26/56 (46%) men who received treatment and provided complete data: these included nausea, headache, and metallic taste (4 participants reported redness or irritation of penile skin).

Author’s Commentary:

Findings of this trial indicate that one week of oral and topical antimicrobial therapy which alters penile microbiota may subsequently reduce the rate of BV recurrence among women who also receive standard of care treatment. This intervention appears effective for partners of women with an IUD as well as uncircumcised partners (although it should be noted the trial was not powered to specifically explore these associations). Given that some studies have noted a higher frequency of BV recurrence among women with HIV, ongoing questions about the microbiome and HIV transmission, and association between BV and certain gynecologic-obstetric outcomes, these results may help inform changes in clinical recommendations and practice for HIV and sexual health providers. 

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