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RECRUITING
NCT06414408
EARLY_PHASE1

Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis (dPEP) study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the Kenyan dPEP study, and to examine the relative performance of these methods within the United States DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-10-18

Completion Date

2028-09-01

Last Updated

2025-03-10

Healthy Volunteers

Yes

Interventions

DRUG

Doxycycline Pill

200mg Dose

Locations (1)

University of California, San Francisco/San Francisco General Hospital

San Francisco, California, United States