Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections

Part of paid clinical trials in Los Angeles, California.

Sponsor
Westat
Study ID
NCT06738407
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Chlamydia
  • Gonorrhea
  • Sexually Transmitted Infections (STIs)
  • Syphilis

Eligibility Criteria

Sex
FEMALE
Age
13 Years - 29 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Feb 27, 2026
Status verified
May 2026
Primary completion
Jun 15, 2028
Completion
Jun 15, 2028

Study Design

Enrollment
760 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Other: 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.

Primary Outcome Measure

Combined incidence of GC, CT, and/or early syphilis infection [ Time Frame: One (1) year ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
UCLA CareLos AngelesCalifornia90095
Emy Arango
[email protected]
310-825-6413
Cherie Blaire (PRINCIPAL_INVESTIGATOR)
San Francisco Department of Public HealthSan FranciscoCalifornia94102
Emily Schaeffer
[email protected]
628-217-7456
Albert Liu (PRINCIPAL_INVESTIGATOR)
Children's National Medical CenterWashington D.C.District of Columbia20010
Justin Unternaher
[email protected]
202-476-1030
Natella Rakhmanina (PRINCIPAL_INVESTIGATOR)
University of FloridaTampaFlorida33612
Elizabeth Enriquez-Bruce
[email protected]
813-250-2574
Patricia Emmanuel (PRINCIPAL_INVESTIGATOR)
Ponce de LeonAtlantaGeorgia30303
Christin Root
[email protected]
404-251-8893
Anandi Sheth (PRINCIPAL_INVESTIGATOR)
University Illinois ChicagoChicagoIllinois60612
Rachel Jackson
[email protected]
312-996-6018
Kelly Bojan (PRINCIPAL_INVESTIGATOR)
Tulane UniversityNew OrleansLouisiana70112
Leslie Kozina
[email protected]
504-988-5348
Tina Simpson (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Jessica Coleman
[email protected]
3013854868
Allison Agwu, MD (PRINCIPAL_INVESTIGATOR)
Harlem Prevention CenterNew YorkNew York10027
Yan Rivera
[email protected]
917-846-9907
Yael Hirsch-Movermann (PRINCIPAL_INVESTIGATOR)
Chapel HillChapel HillNorth Carolina27599
Mariam Chicurel-Bayard
[email protected]
919-843-9922
Lina Rosengren-Hovee (PRINCIPAL_INVESTIGATOR)
Penn PreventionPhiladelphiaPennsylvania19104
Rosemarie Kappes
[email protected]
267-229-2972
Arianne Morrison (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee38015
Mary Dillard
[email protected]
901-595-4083
Aditya Gaur (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Litty Koshy
[email protected]
832-822-1038
Mary Paul (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA Care· Los Angeles, CASan Francisco Department of Public Health· San Francisco, CAChildren's National Medical Center· Washington D.C., DCUniversity of Florida· Tampa, FLPonce de Leon· Atlanta, GAUniversity Illinois Chicago· Chicago, IL

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