Actively Recruiting
Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
Led by University of California, San Francisco · Updated on 2026-04-13
48
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Not currently at risk of a sexually transmitted infection and willing to use other methods, such as condoms, for STI prevention
- If diagnosed with an STI in the past two years and/or a partner was diagnosed with an STI in the past year, willing to use condoms for STI prevention
- Willing to provide hair, blood, and urine samples
- Not currently enrolled in other STI prevention studies
- Able to speak English
- Transgender women participants should be currently using estrogen gender affirming hormone therapy with blood estrogen levels demonstrating consistent use
- Transgender men participants should be currently using testosterone gender affirming hormone therapy with blood testosterone levels demonstrating consistent use
- Able to provide a hair sample of approximately 50-100 strands that are non-gray, not bleached, and at least 1 cm in length
- Willing to not shave hair or have a very short haircut or apply bleach for the duration of the study
- Has suitable venous access for consecutive blood draws
You will not qualify if you...
- Any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions
- Pregnancy or plans to become pregnant
- Liver cirrhosis or fulminant liver disease
- Known hypersensitivity reaction to doxycycline
- Detectable doxycycline in hair at enrollment
- Unable to provide a hair sample of approximately 50-100 strands that are non-gray, not bleached, and at least 1 cm in length
- Does not have suitable venous access for consecutive blood draws
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco/San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
S
Shivani Mahuvakar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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