dPEP-KE
Trial question
What is the role of doxycycline prophylaxis for STIs in cisgender women?
Study design
Multi-center
Open label
RCT
Population
449 female patients.
Inclusion criteria: adult cisgender women who were receiving HIV pre-exposure prophylaxis.
Key exclusion criteria: pregnancy or lactation; allergy to tetracycline class; receipt of medications contraindicated with doxycycline; recent use of prolonged antibiotics in the month prior to enrollment.
Interventions
N=224 doxycycline post-exposure prophylaxis (200 mg doxycycline hyclate within 72 hours after condomless sexual intercourse plus quarterly STI testing and treatment).
N=225 standard care (quarterly STI testing and treatment alone).
Primary outcome
Incidence of incident sexually transmitted infections
25.1
29
29.0/100 py
21.8/100 py
14.5/100 py
7.3/100 py
0.0/100 py
Doxycycline post-exposure
prophylaxis
Standard
care
No significant
difference ↔
No significant difference in the incidence of incident STIs (25.1/100 py vs. 29/100 py; RR 0.88, 95% CI 0.6 to 1.29).
Secondary outcomes
No significant difference in incident C. trachomatis infection (70% vs. 84.7%; RR 0.73, 95% CI 0.47 to 1.13).
No significant difference in first C. trachomatis infection (15% vs. 18.5%; HR 0.8, 95% CI 0.51 to 1.27).
No significant difference in first STI (20.9% vs. 22.1%; HR 0.95, 95% CI 0.64 to 1.42).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult cisgender women who were receiving HIV pre-exposure prophylaxis, doxycycline post-exposure prophylaxis was not superior to standard care with respect to the incidence of incident STIs.
Reference
Jenell Stewart, Kevin Oware, Deborah Donnell et al. Doxycycline Prophylaxis to Prevent Sexually Transmitted Infections in Women. N Engl J Med. 2023 Dec 21;389(25):2331-2340.
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