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A Randomized Controlled Trial of Doxycycline Post Exposure Prophylaxis to Prevent Incident Bacterial STIs Among Women in the United States
Sponsor: Tulane University
Summary
The bacterial sexually transmitted infections (STIs) chlamydia, gonorrhea, and syphilis cause multiple adverse outcomes in women, and prevention strategies are critically needed. This project will determine the efficacy of doxycycline post-exposure prophylaxis (doxy PEP) to prevent STIs among women through a phase IV, open-label, randomized controlled trial.
Key Details
Gender
FEMALE
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
519
Start Date
2027-01-01
Completion Date
2032-04-01
Last Updated
2026-07-15
Healthy Volunteers
No
Interventions
Doxycycline
Enrolled participants will be randomized 2:1 to receive 200 mg of doxy PEP taken within 24 hours of condomless sex versus standard of care. Only one trial of the use of doxy PEP (dPEP Kenya) has been conducted among women, and unfortunately this study had a null result.
Standard of Care (SOC)
Enrolled participants will be randomized 2:1 to receive 200 mg of doxy PEP taken within 24 hours of condomless sex versus standard of care. Only one trial of the use of doxy PEP (dPEP Kenya) has been conducted among women, and unfortunately this study had a null result.