760 Participants Needed

Doxycycline for STDs Prevention

(foXXxy doxy Trial)

Recruiting at 11 trial locations
ER
NL
Overseen ByNancy Liu
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of 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.

Research Team

CB

Cherie Blaire, MD, PhD

Principal Investigator

University of California, Los Angeles

JS

Jenell Stewart, DO, MPH

Principal Investigator

Hennepin Healthcare

Eligibility Criteria

This trial is for individuals assigned female at birth who are seeking to prevent bacterial sexually transmitted infections (STIs). Participants must be willing to take doxycycline weekly and be monitored for the development of antimicrobial resistance.

Inclusion Criteria

Willing to provide written informed consent to participate in the study
I am between 13 and 29 years old.
I was assigned female at birth.
See 4 more

Exclusion Criteria

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
Lack of consistent access (or anticipated weekly access for 52 weeks of survey completion) to smartphone that can access the HMP app
Presence of 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
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive on-demand doxycycline post-exposure prophylaxis, weekly doxycycline, or standard of care, with quarterly STI testing and sexual health counseling

52 weeks
Quarterly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including STI testing and resistance testing

4 weeks

Treatment Details

Interventions

  • Doxycycline
Trial Overview The study tests if taking a delayed-release form of doxycycline hyclate, an antibiotic, can reduce the risk of STIs like gonorrhea, chlamydia, and syphilis. It's an open-label trial where participants know what treatment they're getting.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Weekly doxycyclineExperimental Treatment1 Intervention
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.
Group II: On-demand doxyPEPExperimental Treatment1 Intervention
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.
Group III: Quarterly STI testing/treatment and sexual health counselingActive Control1 Intervention
Participants will be followed per standard of care with quarterly STI testing/treatment and sexual health counseling.

Doxycycline is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Doxycycline for:
  • Acne
  • Bacterial infections
  • Chlamydia
  • Gonorrhea
  • Lyme disease
  • Malaria
  • Pneumonia
  • Rosacea
  • Urinary tract infections
🇪🇺
Approved in European Union as Doxycycline for:
  • Acne
  • Bacterial infections
  • Chlamydia
  • Gonorrhea
  • Lyme disease
  • Malaria
  • Pneumonia
  • Rosacea
  • Urinary tract infections
🇨🇦
Approved in Canada as Doxycycline for:
  • Acne
  • Bacterial infections
  • Chlamydia
  • Gonorrhea
  • Lyme disease
  • Malaria
  • Pneumonia
  • Rosacea
  • Urinary tract infections
🇯🇵
Approved in Japan as Doxycycline for:
  • Acne
  • Bacterial infections
  • Chlamydia
  • Gonorrhea
  • Lyme disease
  • Malaria
  • Pneumonia
  • Rosacea
  • Urinary tract infections

Find a Clinic Near You

Who Is Running the Clinical Trial?

Westat

Lead Sponsor

Trials
49
Recruited
39,700+

National Institute of Allergy and Infectious Diseases (NIAID)/Division of AIDS (DAIDS)

Collaborator

Trials
1
Recruited
760+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Florida State University

Collaborator

Trials
234
Recruited
41,100+
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