Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age13-29
SponsorWestat
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 ;
Trial design
Treatments tested in this trial
- Doxycycline hyclate delayed released 200 mg
- Doxycycline hyclate delayed released 200 mg weekly
- Per standard of care with quarterly STI testing/treatment and sexual health counseling
Treatment groups
760 Participants
are divided into 3 treatment groupsSponsors and collaborators
Westat
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Florida State University
Collaborator
The Office of the Director, National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov