Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
A Pilot, Randomized Controlled Trial of Dual Daily HIV and Sexually Transmitted Infection Pre-exposure Prophylaxis Using Tenofovir Disoproxil Fumarate/Emtricitabine and Doxycycline in Gay, Bisexual, and Other Men Who Have Sex With Men and Transgender Women: The DuDHS Study.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Grennan Troy, Mohammed Saira, Edward Joshua, Tattersall Tessa, Gupta Amit K, Seto Joyce, Dennehy Michelle, Romney Marc G, Zhang Wendy, Li Jenny, Trigg Jason, Lima Viviane D, Juwono Stephen, Wong Jason, Zhang Guijun, Montaner Julio S G, Hull Mark W
Аннотация
BACKGROUND: Men who have sex with men (MSM) and transgender women experience high sexually transmitted infection (STI) rates. This study evaluated the feasibility of doxycycline pre-exposure prophylaxis (doxyPrEP) for STI prevention in these key populations.
METHODS: Sexually-active MSM and transgender women without human immunodeficiency virus (HIV) with prior syphilis were recruited. Participants initiated HIV PrEP with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) daily for 48 weeks and were randomized 1:1 to daily doxyPrEP for 48 weeks (immediate arm), or doxyPrEP initiated at 24 weeks (deferred arm). Primary outcomes included adherence, measured using questionnaires, along with tolerability; STI incidence (chlamydia, gonorrhea, syphilis) was a secondary outcome. Nasal carriage of Staphylococccus aureus was assessed serially for doxycycline resistance.
RESULTS: Fifty-two participants were enrolled into the immediate (n = 26) and deferred (n = 26) arms. At 48 weeks, self-reported adherence (≥95%) was 75.0% versus 66.7% (P = .538) for TDF/FTC, and 70.8% versus 61.9% (P = .526) for doxycycline in the immediate versus deferred arms, respectively. No doxyPrEP-related serious adverse events occurred. Incidence of any STI at 24 weeks was reduced in the immediate versus deferred arms, and over 48 weeks, being on doxycycline (vs being off; ie, first 24 weeks of deferred arm) was associated with STI reduction (adjusted odds ratio [aOR] 0.36; 95% confidence interval [CI]: .15-.89). Emergent doxycycline-resistant S. aureus was identified in six individuals, with five in the immediate arm (P = .077).
CONCLUSIONS: Dual HIV/doxyPrEP is feasible and associated with a significant reduction in incident STI. Further evaluation of dosing strategies, efficacy and impact on antimicrobial resistance is warranted.
METHODS: Sexually-active MSM and transgender women without human immunodeficiency virus (HIV) with prior syphilis were recruited. Participants initiated HIV PrEP with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) daily for 48 weeks and were randomized 1:1 to daily doxyPrEP for 48 weeks (immediate arm), or doxyPrEP initiated at 24 weeks (deferred arm). Primary outcomes included adherence, measured using questionnaires, along with tolerability; STI incidence (chlamydia, gonorrhea, syphilis) was a secondary outcome. Nasal carriage of Staphylococccus aureus was assessed serially for doxycycline resistance.
RESULTS: Fifty-two participants were enrolled into the immediate (n = 26) and deferred (n = 26) arms. At 48 weeks, self-reported adherence (≥95%) was 75.0% versus 66.7% (P = .538) for TDF/FTC, and 70.8% versus 61.9% (P = .526) for doxycycline in the immediate versus deferred arms, respectively. No doxyPrEP-related serious adverse events occurred. Incidence of any STI at 24 weeks was reduced in the immediate versus deferred arms, and over 48 weeks, being on doxycycline (vs being off; ie, first 24 weeks of deferred arm) was associated with STI reduction (adjusted odds ratio [aOR] 0.36; 95% confidence interval [CI]: .15-.89). Emergent doxycycline-resistant S. aureus was identified in six individuals, with five in the immediate arm (P = .077).
CONCLUSIONS: Dual HIV/doxyPrEP is feasible and associated with a significant reduction in incident STI. Further evaluation of dosing strategies, efficacy and impact on antimicrobial resistance is warranted.