Actively Recruiting
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections Among Adolescent and Young Adult Females in the United States
Led by Westat · Updated on 2026-05-15
760
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Westat
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate doxycycline as a preventive treatment to reduce bacterial sexually transmitted infections (STIs) such as gonorrhea, chlamydia, and early syphilis in adolescent and young adult females. The study also assesses how acceptable doxycycline use is and monitors antibiotic resistance, providing important information for public health decisions. The trial is open-label and randomized, enrolling females aged 13 to 29 years with recent STI exposure or infection. Participants are randomly assigned to one of three groups: on-demand doxycycline post-exposure prophylaxis (200 mg taken shortly after condomless sex), weekly doxycycline (200 mg once a week regardless of sexual activity), or standard care involving quarterly STI testing and counseling. The study lasts one year with quarterly visits for testing and monitoring. Participants provide self-collected vaginal and rectal swabs, complete surveys, and use a smartphone app for weekly reporting of sexual activity and medication adherence. Resistance testing for doxycycline is also conducted on bacterial samples. Throughout the year, participants attend quarterly study visits for STI testing, safety checks, surveys, and sample collection. They use a mobile app to report weekly sexual activity and medication use to support adherence monitoring. Researchers measure combined rates of gonorrhea, chlamydia, and early syphilis infections as the primary outcome. Additional testing for antimicrobial resistance and participant acceptability of treatments is also conducted. The study involves close follow-up and safety monitoring over the full year.
CONDITIONS
Brief Title
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 13 to 29 years inclusive
- Self-reported diagnosis of gonorrhea, chlamydia, or early syphilis in the 12 months before screening
- Self-reported condomless oral, vaginal, or anal sex at least once in the 30 days before screening
- Weighs at least 45 kilograms (99.2 pounds)
- Fluent in English
- Willing to complete all required study procedures
- Willing to provide written informed consent
You will not qualify if you...
- Male sex
- Pregnant, breastfeeding, or planning pregnancy in the next 12 months
- History of allergy to tetracyclines
- Current or expected use of medications that interact with doxycycline
- Use of doxycycline for longer than 2 weeks in the 30 days before enrollment
- Prolonged antibiotic use over 2 weeks in the last 30 days
- Participation in other interventional studies that may interfere with this trial without approval
- No consistent access to a smartphone for weekly app use
- Any medical or behavioral condition that may interfere with study adherence or results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 year
Participants are randomized to receive either on-demand doxycycline post-exposure prophylaxis, weekly doxycycline, or standard of care with quarterly STI testing and sexual health counseling.
Quarterly visits for STI testing, surveys, safety monitoring, and specimen collection; weekly app assessments of sexual activity and medication adherence
Trial Site Locations
Total: 13 locations
1
UCLA Care
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
San Francisco Department of Public Health
San Francisco, California, United States, 94102
Actively Recruiting
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
University of Florida
Tampa, Florida, United States, 33612
Actively Recruiting
5
Ponce de Leon
Atlanta, Georgia, United States, 30303
Not Yet Recruiting
6
University Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
7
Tulane University
New Orleans, Louisiana, United States, 70112
Not Yet Recruiting
8
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
9
Harlem Prevention Center
New York, New York, United States, 10027
Not Yet Recruiting
10
Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
11
Penn Prevention
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
12
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38015
Actively Recruiting
13
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nancy Liu
E
Erin Ricketts
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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