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Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections Among Adolescent and Young Adult Females in the United States

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 13
Maximum Age: 29
Healthy Volunteers: f
View:

• Age 13-29 years, inclusive;

• Self-reports GC, CT, and/or early syphilis diagnosis in the 12 months prior to screening;

• Self-reports condomless (oral, vaginal, and/or anal) intercourse at least once in the 30 days prior to screening

• Is at least 45 kilograms (99.2 pounds) in weight

• Fluent in English (able to read, speak, and understand English);

• Willing to undergo all required study procedures; and

• Willing to provide written informed consent to participate in the study.

Locations
United States
California
UCLA Care
NOT_YET_RECRUITING
Los Angeles
San Francisco Department of Public Health
RECRUITING
San Francisco
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Florida
University of Florida
RECRUITING
Tampa
Georgia
Ponce de Leon
NOT_YET_RECRUITING
Atlanta
Illinois
University Illinois Chicago
RECRUITING
Chicago
Louisiana
Tulane University
NOT_YET_RECRUITING
New Orleans
Maryland
Johns Hopkins University
NOT_YET_RECRUITING
Baltimore
North Carolina
Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
New York
Harlem Prevention Center
NOT_YET_RECRUITING
New York
Pennsylvania
Penn Prevention
NOT_YET_RECRUITING
Philadelphia
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Nancy Liu
NancyLiu@westat.com
718-980-3937
Backup
Erin Ricketts
ErinRicketts@westat.com
240-453-2786
Time Frame
Start Date: 2026-02-27
Estimated Completion Date: 2028-06-15
Participants
Target number of participants: 760
Treatments
Experimental: On-demand doxyPEP
Participants will take by mouth doxycycline 200 mg as soon as possible and within 72 hours after any condomless oral, vaginal, and/or anal sex in addition to standard of care STI testing/treatment and sexual health counseling.
Experimental: Weekly doxycycline
Participants will take by mouth doxycycline 200 mg weekly regardless of sexual activity in addition to standard of care STI testing/treatment and sexual health counseling.
Other: Quarterly STI testing/treatment and sexual health counseling
Participants will be followed per standard of care with quarterly STI testing/treatment and sexual health counseling.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA), Florida State University, National Institute of Mental Health (NIMH), The Office of the Director, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Westat

This content was sourced from clinicaltrials.gov

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