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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06414408
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Sexually Transmitted Diseases, Bacterial

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Doxycycline Pill — DRUG
    200mg Dose

Study Details

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 Dates

Start date
Oct 18, 2024
Status verified
Apr 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Daily Dosing
    Participants will be randomized to take once daily doxycycline 200mg for six weeks.
  • Active Comparator: Three-times Weekly Dosing
    Participants will be randomized to take one doxycycline 200mg dose three times a week (Monday, Wednesday, and Friday) for six weeks.
  • Active Comparator: Weekly Dosing
    Participants will be randomized to take one doxycycline 200mg dose once week.
  • Active Comparator: Every Other Week Dosing
    Participants will be randomized to take one doxycycline 200mg dose every other week.

Primary Outcome Measure

Hair Doxycycline Concentration [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San Francisco/San Francisco General HospitalSan FranciscoCalifornia94110
Matthew A Spinelli, MD, MAS
[email protected]

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University of California, San Francisco/San Francisco General Hospital· San Francisco, CA