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Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections

NCT06738407 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2026-05-15

No results posted yet for this study

Summary

The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also evaluating acceptability and antimicrobial resistance in order to inform public health policy.

Conditions

  • Gonorrhea
  • Chlamydia
  • Syphilis
  • Sexually Transmitted Infections (STIs)

Interventions

DRUG

Doxycycline hyclate delayed released 200 mg

200 mg of doxycycline taken by mouth as soon as possible and within 72 hours after any condomless oral, vaginal, and/or anal sex along with STI screening and sexual health counseling

DRUG

Doxycycline hyclate delayed released 200 mg weekly

200 mg of doxycycline taken by mouth weekly regardless of sexual activity along with STI screening and sexual health counseling

OTHER

Per standard of care with quarterly STI testing/treatment and sexual health counseling

Quarterly STI testing/treatment and sexual health counseling

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Florida State University

    collaborator OTHER

  • The Office of the Director, National Institutes of Health (NIH)

    collaborator UNKNOWN

  • Westat

    lead OTHER

Principal Investigators

  • Cherie Blaire, MD, PhD · University of California, Los Angeles

  • Jenell Stewart, DO, MPH · Hennepin Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
29 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-27
Primary Completion
2028-06-15
Completion
2028-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06738407 on ClinicalTrials.gov