• Anne F Luetkemeyer, Deborah Donnell, Julia C Dombrowski, Stephanie Cohen, Cole Grabow, Clare E Brown, Cheryl Malinski, Rodney Perkins, Melody Nasser, Carolina Lopez, Eric Vittinghoff, Susan P Buchbinder, Hyman Scott, Edwin D Charlebois, Diane V Havlir, Olusegun O Soge, Connie Celum, and DoxyPEP Study Team.
• From Zuckerberg San Francisco General Hospital and Trauma Center (A.F.L., C.L., D.V.H.), and the Departments of Medicine (A.F.L., S.C., C.L., E.V., D.V.H.) and Epidemiology and Biostatistics (E.D.C), University of California, San Francisco, and San Francisco Department of Public Health, Population Health Division (S.C., M.N., S.P.B., H.S.) - both in San Francisco; and Fred Hutchinson Cancer Center (D.D.), the Departments of Medicine (J.C.D., O.O.S., C.C.), Global Health (C.G., C.E.B., R.P., O.O.S., C.C.), and Epidemiology (C.C.), and the School of Nursing (R.P.), University of Washington, and Public Health-Seattle and King County (J.C.D., C.M.) - all in Seattle.
• N. Engl. J. Med. 2023 Apr 6; 388 (14): 129613061296-1306.

BackgroundInterventions to reduce sexually transmitted infections (STIs) among men who have sex with men (MSM) are needed.MethodsWe conducted an open-label, randomized study involving MSM and transgender women who were taking preexposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection (PrEP cohort) or living with HIV infection (persons living with HIV infection [PLWH] cohort) and who had had Neisseria gonorrhoeae (gonorrhea), Chlamydia trachomatis (chlamydia), or syphilis in the past year. Participants were randomly assigned in a 2:1 ratio to take 200 mg of doxycycline within 72 hours after condomless sex (doxycycline postexposure prophylaxis) or receive standard care without doxycycline. STI testing was performed quarterly. The primary end point was the incidence of at least one STI per follow-up quarter.ResultsOf 501 participants (327 in the PrEP cohort and 174 in the PLWH cohort), 67% were White, 7% Black, 11% Asian or Pacific Islander, and 30% Hispanic or Latino. In the PrEP cohort, an STI was diagnosed in 61 of 570 quarterly visits (10.7%) in the doxycycline group and 82 of 257 quarterly visits (31.9%) in the standard-care group, for an absolute difference of -21.2 percentage points and a relative risk of 0.34 (95% confidence interval [CI], 0.24 to 0.46; P<0.001). In the PLWH cohort, an STI was diagnosed in 36 of 305 quarterly visits (11.8%) in the doxycycline group and 39 of 128 quarterly visits (30.5%) in the standard-care group, for an absolute difference of -18.7 percentage points and a relative risk of 0.38 (95% CI, 0.24 to 0.60; P<0.001). The incidences of the three evaluated STIs were lower with doxycycline than with standard care; in the PrEP cohort, the relative risks were 0.45 (95% CI, 0.32 to 0.65) for gonorrhea, 0.12 (95% CI, 0.05 to 0.25) for chlamydia, and 0.13 (95% CI, 0.03 to 0.59) for syphilis, and in the PLWH cohort, the relative risks were 0.43 (95% CI, 0.26 to 0.71), 0.26 (95% CI, 0.12 to 0.57), and 0.23 (95% CI, 0.04 to 1.29), respectively. Five grade 3 adverse events and no serious adverse events were attributed to doxycycline. Of the participants with gonorrhea culture available, tetracycline-resistant gonorrhea occurred in 5 of 13 in the doxycycline groups and 2 of 16 in the standard-care groups.ConclusionsThe combined incidence of gonorrhea, chlamydia, and syphilis was lower by two thirds with doxycycline postexposure prophylaxis than with standard care, a finding that supports its use among MSM with recent bacterial STIs. (Funded by the National Institutes of Health; DoxyPEP ClinicalTrials.gov number, NCT03980223.).Copyright © 2023 Massachusetts Medical Society.

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