Got Doxy- 'Flipping the Script' on STI PEP

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Sexually Transmitted Infections (STI)
Interventions
DRUG

Doxycycline monohydrate 200 mg

"Doxycycline monohydrate 200 mg (two 100 mg pills) is used to treat or prevent infections that are strongly suspected to be caused by bacteria. Doxycycline monohydrate is an antimicrobial drug indicated for the treatment of bacterial infections, including sexually transmitted diseases. CDC recommends its use as post-exposure prophylaxis (PEP).~Blood and rectal mucosal samples will be collected before the initiation of doxycycline. Participants will be instructed to take 200 mg of doxycycline by mouth every Monday, Wednesday, and Friday. Additional doses of doxycycline will be permitted on other days if sex without a condom occurs per CDC guidance. After 12 weeks of at least thrice weekly doxycycline, blood and rectal mucosal samples will again be collected for immunologic and microbiome/resistome assays."

OTHER

Observation

Standard of care. Blood and rectal mucosal samples.

Trial Locations (2)

30322

Grady Health System (non-CRN), Atlanta

Hope Clinic, Atlanta

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Emory University

OTHER