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A Randomized Controlled Trial of Doxycycline Post Exposure Prophylaxis to Prevent Incident Bacterial STIs Among Women in the United States

NCT07704957 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 519

Last updated 2026-07-15

No results posted yet for this study

Summary

The bacterial sexually transmitted infections (STIs) chlamydia, gonorrhea, and syphilis cause multiple adverse outcomes in women, and prevention strategies are critically needed. This project will determine the efficacy of doxycycline post-exposure prophylaxis (doxy PEP) to prevent STIs among women through a phase IV, open-label, randomized controlled trial.

Conditions

  • Chlamydia Females
  • Gonorrhea Female
  • Syphilis Female
  • Adherence
  • Prophylaxis
  • Prevention

Interventions

DRUG

Doxycycline

Enrolled participants will be randomized 2:1 to receive 200 mg of doxy PEP taken within 24 hours of condomless sex versus standard of care. Only one trial of the use of doxy PEP (dPEP Kenya) has been conducted among women, and unfortunately this study had a null result.

OTHER

Standard of Care (SOC)

Enrolled participants will be randomized 2:1 to receive 200 mg of doxy PEP taken within 24 hours of condomless sex versus standard of care. Only one trial of the use of doxy PEP (dPEP Kenya) has been conducted among women, and unfortunately this study had a null result.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Alabama at Birmingham

    collaborator OTHER

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER

  • Tulane University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2031-02-28
Completion
2032-04-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07704957 on ClinicalTrials.gov