Actively Recruiting
Got Doxy- 'Flipping the Script' on STI PEP
Led by Emory University · Updated on 2026-04-30
200
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is being done to test the effects of doxycycline on inflammation and the bacteria in the body in people with HIV and in people on HIV pre-exposure prophylaxis. This drug is approved by the Food and Drug Administration (FDA) for the treatment of bacterial infections. The study team will investigate whether the drug has additional effects on inflammation or on the bacteria that live in the body.
CONDITIONS
Official Title
Got Doxy- 'Flipping the Script' on STI PEP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Assigned male sex at birth
- Good general health as confirmed by a clinician at screening
- For people with HIV, on suppressive antiretroviral therapy for at least 6 months with viral load under 50 copies/ml and CD4 count over 300 cells/ul
- For people without HIV, taking oral daily, oral on-demand, or injectable pre-exposure prophylaxis for at least 3 months with plans to continue during the study
- Additional criteria apply
You will not qualify if you...
- Severe or uncontrolled medical conditions that may affect immune outcomes (e.g., diabetes, hypertension, co-infections)
- History of inflammatory bowel disease or other inflammatory or infectious conditions of the lower gastrointestinal tract that may be worsened by study procedures or alter bowel anatomy
- Known allergy to doxycycline
- Use of any antibiotics within 3 months before screening
- Significant laboratory abnormalities at baseline visit for rectal biopsies
- Need to continue certain medications during the study including aspirin, blood thinners (warfarin, heparin), platelet inhibitors, fibrinolytics, rectally administered agents other than lubricants or douching for sexual intercourse, or NSAIDs within 72 hours of rectal sampling
- Use or need for systemic immunomodulatory agents or high-dose corticosteroids within 90 days before enrollment (gender affirming hormone therapy allowed)
- Use of experimental medications, vaccines, or biologicals within 12 months before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Grady Health System (non-CRN)
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Hope Clinic
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
C
Colleen Kelley, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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