Got Doxy- 'Flipping the Script' on STI PEP

Conditions

• Sexually Transmitted Infections (STI)

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Doxycycline monohydrate 200 mg — DRUG
  Doxycycline monohydrate 200 mg (two 100 mg tablets) 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. Centers for Disease Control and Prevention (CDC) recommends its use as post-exposure prophylaxis (PEP). Blood and rectal mucosal samples will be collected before doxycycline is initiated. 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 three-weekly doxycycline, blood and rectal mucosal samples will be collected for immunologic and microbiome/resistome assays.
• Observation — OTHER
  Standard of care. Blood and rectal mucosal samples.

Study Details

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.

Key Dates

Start date

Oct 13, 2025

Status verified

Apr 2026

Primary completion

Apr 13, 2029

Completion

Apr 13, 2029

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Doxycycline 200mg
  Males with HIV infection on antiretroviral therapy or without HIV infection on HIV pre-exposure prophylaxis who are not taking doxy-PEP will be enrolled and randomized to take 12 weeks of doxycycline 200 mg by mouth three times weekly. Blood and rectal mucosal samples will be collected before the initiation of doxycycline.
• Active Comparator: Observation with biological sampling
  Males with HIV infection on antiretroviral therapy or without HIV infection on HIV pre-exposure prophylaxis who are not taking doxy-PEP will receive standard of care and will undergo biological sampling.

Primary Outcome Measure

Composite inflammation score [ Time Frame: Baseline and 12 weeks after the start of doxycycline administration ]

Central Contacts

• Colleen Kelley, MD, MPH
  404-712-1823
  [email protected]

Locations (2)

Find similar trials in Atlanta, GA

Related Studies

• California MEPS Hub
  Recruiting · University of California, Los Angeles · Oakland, California