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Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
RecruitingPhase 4
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections Among Adolescent and Young Adult Females in the United States
Who can join
Ages 13 to 29 · Women
Full 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.
About the study
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.
What is being tested
- Doxycycline hyclate delayed released 200 mg (drug)
- Doxycycline hyclate delayed released 200 mg weekly (drug)
- Per standard of care with quarterly STI testing/treatment and sexual health counseling (other)
Sponsor: Westat · Participants: 760 · Started: Feb 27, 2026
Contact the study team
- Nancy Liu · Phone: 718-980-3937
- Erin Ricketts · Phone: 240-453-2786
Official record on ClinicalTrials.gov — NCT06738407
Locations in the U.S.
| California | UCLA Care, Los Angeles (Not yet recruiting) San Francisco Department of Public Health, San Francisco |
| District of Columbia | Children's National Medical Center, Washington D.C. |
| Florida | University of Florida, Tampa |
| Georgia | Ponce de Leon, Atlanta (Not yet recruiting) |
| Illinois | University Illinois Chicago, Chicago |
| Louisiana | Tulane University, New Orleans (Not yet recruiting) |
| Maryland | Johns Hopkins University, Baltimore (Not yet recruiting) |
| New York | Harlem Prevention Center, New York (Not yet recruiting) |
| North Carolina | Chapel Hill, Chapel Hill (Not yet recruiting) |
| Pennsylvania | Penn Prevention, Philadelphia (Not yet recruiting) |
| Tennessee | St. Jude Children's Research Hospital, Memphis |
| Texas | Baylor College of Medicine, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.