• Jenell Stewart, Kevin Oware, Deborah Donnell, Lauren R Violette, Josephine Odoyo, Olusegun O Soge, Caitlin W Scoville, Victor Omollo, Felix O Mogaka, Fredericka A Sesay, R Scott McClelland, Matthew Spinelli, Monica Gandhi, Elizabeth A Bukusi, Jared M Baeten, and dPEP Kenya Study Team.
• From the Division of Infectious Diseases, Hennepin Healthcare Research Institute, and the Department of Medicine, University of Minnesota - both in Minneapolis (J.S.); Kenya Medical Research Institute, Kisumu (K.O., J.O., V.O., F.O.M., E.A.B.); Fred Hutchinson Cancer Research Center (D.D.) and the Departments of Epidemiology (L.R.V., F.A.S., R.S.M.), Global Health (O.O.S., C.W.S., R.S.M., E.A.B., J.M.B.), Medicine (Infectious Diseases) (L.R.V., O.O.S., R.S.M., J.M.B.), and Obstetrics and Gynecology (E.A.B.), University of Washington, Seattle; and the Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco (M.S., M.G.).
• N. Engl. J. Med. 2023 Dec 21; 389 (25): 233123402331-2340.

BackgroundDoxycycline postexposure prophylaxis (PEP) has been shown to prevent sexually transmitted infections (STIs) among cisgender men and transgender women, but data from trials involving cisgender women are lacking.MethodsWe conducted a randomized, open-label trial comparing doxycycline PEP (doxycycline hyclate, 200 mg taken within 72 hours after condomless sex) with standard care among Kenyan women 18 to 30 years of age who were receiving preexposure prophylaxis against human immunodeficiency virus (HIV). The primary end point was any incident infection with Chlamydia trachomatis, Neisseria gonorrhoeae, or Treponema pallidum. Hair samples were collected quarterly for objective assessment of doxycycline use.ResultsA total of 449 participants underwent randomization; 224 were assigned to the doxycycline-PEP group and 225 to the standard-care group. Participants were followed quarterly over 12 months. A total of 109 incident STIs occurred (50 in the doxycycline-PEP group [25.1 per 100 person-years] and 59 in the standard-care group [29.0 per 100 person-years]), with no significant between-group difference in incidence (relative risk, 0.88; 95% confidence interval [CI], 0.60 to 1.29; P = 0.51). Among the 109 incident STIs, chlamydia accounted for 85 (78.0%) (35 in the doxycycline-PEP group and 50 in the standard-care group; relative risk, 0.73; 95% CI, 0.47 to 1.13). No serious adverse events were considered by the trial investigators to be related to doxycycline, and there were no incident HIV infections. Among 50 randomly selected participants in the doxycycline-PEP group, doxycycline was detected in 58 of 200 hair samples (29.0%). All N. gonorrhoeae-positive isolates were resistant to doxycycline.ConclusionsAmong cisgender women, the incidence of STIs was not significantly lower with doxycycline PEP than with standard care. According to hair-sample analysis, the use of doxycycline PEP among those assigned to receive it was low. (Funded by the National Institutes of Health; dPEP ClinicalTrials.gov number, NCT04050540.).Copyright © 2023 Massachusetts Medical Society.

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