Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens

Description

The goal of this project is to collect data regarding the concentrations of doxycycline in mucosal tissues after daily dosing for 7 days in people assigned male sex at birth (AMAB) and assigned female sex at birth (AFAB) to inform future studies of doxycycline to protect against bacterial sexually transmitted infections (STIs).

Conditions

Sexually Transmitted Infection

Study Overview

Study Details

Study overview

The goal of this project is to collect data regarding the concentrations of doxycycline in mucosal tissues after daily dosing for 7 days in people assigned male sex at birth (AMAB) and assigned female sex at birth (AFAB) to inform future studies of doxycycline to protect against bacterial sexually transmitted infections (STIs).

Daily Doxy: Study of Persons Receiving Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens

Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens

Condition
Sexually Transmitted Infection
Intervention / Treatment

-

Contacts and Locations

Atlanta

Hope Clinic, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Assigned male sex or female sex at birth
  • * In good general health
  • * Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
  • * For HIV positive people, on stable antiretroviral therapy with an undetectable viral load and cluster of differentiation 4 (CD4) count\> 300ul/ml
  • * Willing to use condoms consistently for the duration of the study
  • * Able to provide informed consent
  • * No plans for relocation in the next 4 months
  • * Not pregnant and does not plan on getting pregnant for the duration of the study
  • * Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure
  • * Willing to use study products as directed
  • * Current or chronic history of liver disease
  • * Continued need for, or use during the 90 days prior to enrollment, of the following medications:
  • * Systemic immunomodulatory agents
  • * Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
  • * Chemotherapy or radiation for treatment of malignancy
  • * Experimental medications, vaccines, or biologicals
  • * Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures
  • * Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements
  • * Known allergic reaction to study drugs
  • * Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to:
  • * Hemoglobin (Hgb) ≤ 10 g/dL
  • * Partial thromboplastin time (PTT) \> 1.5x upper limit of normal (ULN) or international normalised ratio (INR) \> 1.5x ULN
  • * Platelet count \<100,000

Ages Eligible for Study

18 Years to 59 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Emory University,

Colleen Kelley, MD, MPH, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2025-09