RECRUITING Phase 4 ClinicalTrials.gov

Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections

Sponsor: Westat • ClinicalTrials.gov ID: NCT06738407

Registry updated: 2026-10-16

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Description

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.

Interventions

Doxycycline hyclate delayed released 200 mg (Drug)
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
Doxycycline hyclate delayed released 200 mg weekly (Drug)
200 mg of doxycycline taken by mouth weekly regardless of sexual activity along with STI screening and sexual health counseling
Per standard of care with quarterly STI testing/treatment and sexual health counseling (Other)
Quarterly STI testing/treatment and sexual health counseling

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Is male; * Is pregnant, breastfeeding, or planning to become pregnant in the next 12 months; * Documented history of tetracycline allergy or self-reports an allergy to tetracyclines; * Current or anticipated use of a medication (e.g., barbiturates, phenytoin, lithium, carbamazepine, systemic retinoids, warfarin) with a contraindicated interaction to doxycycline ; * Current or planned use of doxycycline for a prolonged period (\> 2 weeks) in the 30 days prior to enrollment, including current prescription for doxycycline for STI prophylaxis; * Prolonged antibiotic use (\> 2 weeks) within the last 30 days prior to enrollment; * Co-enrollment in any other concurrent interventional research or studies that may interfere with this study, such as an STI prevention trial, unless approved by Protocol Team in writing; * Does not have consistent access (or anticipated weekly access for 52 weeks of survey completion) to smartphone that can access the HMP app; or * Any other medical condition, medical/behavioral intervention, or other conditions that, in the opinion of the clinical site Project Lead (PL)/Investigator of Record (IoR) or designee, could interfere with adherence to study procedures or compromise interpretation of study results.

Conditions

Gonorrhea Chlamydia Syphilis Sexually Transmitted Infections (STIs)

Locations

UCLA Care — Los Angeles, California, United States
San Francisco Department of Public Health — San Francisco, California, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
University of Florida — Tampa, Florida, United States
Ponce de Leon — Atlanta, Georgia, United States
University Illinois Chicago — Chicago, Illinois, United States
Tulane University — New Orleans, Louisiana, United States
Johns Hopkins University — Baltimore, Maryland, United States
Harlem Prevention Center — New York, New York, United States
Chapel Hill — Chapel Hill, North Carolina, United States
Penn Prevention — Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Baylor College of Medicine — Houston, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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