Addition of treatment for trichomoniasis to syndromic management of urethritis in Malawi: A randomized clinical trial

Background: Male urethritis is generally treated syndromically, but failure of empirical treatment is common. Goal: The study goal was to evaluate the addition of metronidazole to the syndromic management of urethritis in Malawi in a randomized clinical trial. Study Design: Men with urethritis were randomized to receive either 2 g of metronidazole by mouth or placebo, in addition to standard care for urethritis (i.e., a single intramuscular dose of 240 mg gentamicin and 100 mg doxycycline twice daily for 7 days). The primary endpoints of the study included measurement of the effects of treatment on Trichomonas vaginalis, signs and symptoms of urethritis, and the concentration of HIV RNA in semen in dually infected subjects. Results: The overall prevalence of T vaginalis was 17.3% (71/411), and treatment with metronidazole cleared 95% of culture-positive infections, compared with 54% clearance among men receiving placebo (P = 0.006). Prevalence of persistent urethritis was observed in approximately 16% of both groups at the end of 1 week (29/179 of those receiving metronidazole versus 29/187 in the placebo group; P = 0.86). For a subset of HIV-infected men with trichomoniasis, the seminal plasma HIV RNA concentration was lower than in a group of HIV-positive control subjects (P = 0.052). Conclusion: In areas with a high prevalence of trichomoniasis, the addition of metronidazole to the syndromic management of male urethritis can eliminate infection with T vaginalis and may help to reduce the transmission of HIV. Such treatment should be strongly considered as part of empirical therapy for urethritis in men in Malawi and places where T vaginalis infection in men is common.