Sexually Transmitted Diseases
Article
Addition of Treatment for Trichomoniasis to Syndromic Management of Urethritis in Malawi:
A Randomized Clinical Trial
PRICE, MATTHEW A.*; ZIMBA, DICKMANa†‡; HOFFMAN, IRVING F.†; KAYDOS-DANIELS, S. CORNELIA*; MILLER, WILLIAM C.*†; MARTINSON, FRANCIS‡; CHILONGOZI, DAVID‡; KIP, ESTER‡; MSOWOYA, ESNATH‡; HOBBS, MARCIA M.†; KAZEMBE, PETER N.‡; COHEN, MYRON S.*†
Departments of *Epidemiology and †Medicine at the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, and the ‡Lilongwe Central Hospital, Lilongwe, Malawi
aDeceased.
The authors thank the study staff and clients of the Lilongwe Central Hospital; the staff at the UNC Project in Lilongwe, Malawi; and Paul Stewart for his help in the methods and statistical design of the trial. This work was undertaken in part for the doctoral degree requirements of Dickman Zimba, who unfortunately died before the completion of the trial.
This project was supported by the UNC Fogarty Center (D43-TW01039), NIDDK (R01-DK49381), UNC HIV Prevention Treatment Network (U01-AI48005), and UNC STD Cooperative Research Center (U19-AI31496).
Preliminary data from this trial was presented at the 2001 ISSTDR International Congress, in Berlin, Germany (abstract number 107).
Reprint requests: Myron S. Cohen, MD, 547 Burnett Womack Building, CB 17030, UNC, Chapel Hill, NC 27599-7030. E-mail: [email protected]
Received October 11, 2002,
revised January 7, 2002, and accepted January 8, 2003.
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.