RecruitingPhase 4

Got Doxy- 'Flipping the Script' on STI PEP

United States200 participantsStarted 2025-10-13

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Aspirin
. Warfarin, heparin (LMW or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
. Any form of rectally administered agent besides products (lubricants or douching) used for sexual intercourse
. NSAIDS within 72 hours of rectal sampling procedures
. Systemic immunomodulatory agents
. Supraphysiologic doses of corticosteroids, except for short-course corticosteroids \<7 days duration at the discretion of the investigator. (Gender affirming hormone therapy is not exclusionary.)
. Use of experimental medications, vaccines, or biologicals in the 12 months before enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite inflammation score

Timeframe: Baseline and 12 weeks after the start of doxycycline administration

Trial details

NCT IDNCT07215325

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-13

Contact for this trial

Colleen Kelley, MD, MPH

404-712-1823 kelley@emory.edu

View on ClinicalTrials.gov More Sexually Transmitted Infections (STI) trials