Doxycycline Prophylaxis to Prevent STIs in Adolescent and Young Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized study assigns about 760 female participants aged 13–29 to one of three arms: on-demand doxycycline post-exposure prophylaxis, weekly doxycycline, or standard of care with routine STI testing and counseling. Participants are followed for one year with quarterly visits to monitor STI incidence, safety, adherence, and acceptability, plus laboratory assessments for doxycycline resistance and microbiome analyses. The trial also examines how well participants adhere to dosing and their views on weekly versus on-demand regimens. Results will inform public health policy on doxycycline use for STI prevention among young females.

Why it matters

Who can join: the full rules

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.

Where it's running

• UCLA Care
  Los Angeles, California, United States Recruiting
• San Francisco Department of Public Health
  San Francisco, California, United States Recruiting
• Children's National Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• University of Florida
  Tampa, Florida, United States Recruiting
• Ponce de Leon
  Atlanta, Georgia, United States Recruiting
• University Illinois Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Nancy Liu
• Email: NancyLiu@westat.com
• Phone: 718-980-3937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.