Directly observed doxycycline dosing to clarify Doxy-PEP results
Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
['FUNDING_R01'] · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · NIH-11369756
This project measures how people take doxycycline and tracks drug levels in blood and mucosal sites in cisgender men, cisgender women, and transgender women who might use doxycycline after sex to prevent bacterial STIs.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO (nih funded) |
| Locations | 1 site (SAN FRANCISCO, UNITED STATES) |
| Trial ID | NIH-11369756 on ClinicalTrials.gov |
What this research studies
If I join, staff will directly observe me taking doxycycline pills in a randomized cross-over design so researchers know exactly when doses are taken. The team will collect blood and mucosal samples during dosing and after a washout period to measure doxycycline concentrations over time. The study will enroll 36 adults (12 cisgender men, 12 cisgender women, and 12 transgender women) and link pharmacokinetic data with sexual behavior information from prior DoxyPEP trials. That combined data will be used to define drug-level cutoffs that indicate recent pill-taking.
Who could benefit from this research
Good fit: Adults who are cisgender men, cisgender women, or transgender women who can take doxycycline under observation and provide blood and mucosal samples are ideal candidates.
Not a fit: People who are allergic to doxycycline, are pregnant or breastfeeding, or cannot attend in-person observed dosing visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this work could define clear drug-level evidence of pill-taking that helps explain past trial results and guide safer, more effective doxycycline PEP use to prevent bacterial STIs.
How similar studies have performed: Previous DoxyPEP trials showed benefit in men who have sex with men and transgender women but not cisgender women, and directly observed therapy has been used successfully in HIV PrEP research to link pill-taking with drug levels, so this applies a proven method to a new question.
Where this research is happening
SAN FRANCISCO, UNITED STATES
- UNIVERSITY OF CALIFORNIA, SAN FRANCISCO — SAN FRANCISCO, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: SPINELLI, MATTHEW A. — UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- Study coordinator: SPINELLI, MATTHEW A.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions: Acquired Immune Deficiency Syndrome Virus, Acquired Immunodeficiency Syndrome Virus