Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
NCT ID: NCT06738407
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
760 participants
INTERVENTIONAL
2026-01-05
2028-06-15
Brief Summary
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Detailed Description
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Approximately 760 females will be randomized 1:1:1 to (1) on-demand doxyPEP (doxycycline 200 mg as soon as possible and within 72 hours after any condomless oral, vaginal, and/or anal sex), (2) weekly doxycycline (doxycycline 200 mg weekly regardless of sexual activity), or (3) SOC (quarterly STI testing/treatment and sexual health counseling). Participants will complete quarterly study visits over the course of 1 year during which they will receive STI testing (GC, CT, and syphilis), complete surveys, undergo safety monitoring, provide specimens for objective markers of doxycycline adherence and other laboratory assessments, and provide specimens (vaginal and rectal swabs \[participant self-collected or staff-collected if the participant prefers\]) for future testing, such as microbiome analysis. Resistance testing will be conducted on Staphylococcus (S.) aureus and Neisseria (N.) gonorrhoeae isolates to evaluate for doxycycline and tetracycline resistance, respectively. Participants will also complete weekly assessments of sexual activity and doxycycline adherence via the HealthMpowerment (HMP) application (app).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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
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.
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
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.
Per standard of care with quarterly STI testing/treatment and sexual health counseling
Quarterly STI testing/treatment and sexual health counseling
Interventions
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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
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
Per standard of care with quarterly STI testing/treatment and sexual health counseling
Quarterly STI testing/treatment and sexual health counseling
Eligibility Criteria
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Inclusion Criteria
* 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 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.
13 Years
29 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)/Division of AIDS (DAIDS)
UNKNOWN
National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
Florida State University
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
The Office of the Director, National Institutes of Health (NIH)
UNKNOWN
Westat
OTHER
Responsible Party
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Principal Investigators
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Cherie Blaire, MD, PhD
Role: STUDY_CHAIR
University of California, Los Angeles
Jenell Stewart, DO, MPH
Role: STUDY_CHAIR
Hennepin Healthcare
Locations
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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
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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