Doxycycline for STDs Prevention

(foXXxy doxy Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Westat

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

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

Cherie Blaire, MD, PhD

Principal Investigator

University of California, Los Angeles

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.

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

Treatment Details

Interventions

• Doxycycline (Anti-bacterial)

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

Group I: Weekly doxycycline Experimental Treatment 1 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 doxyPEP Experimental Treatment 1 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 counseling Active Control 1 Intervention

Participants will be followed per standard of care with quarterly STI testing/treatment and sexual health counseling.

Doxycycline is already approved in Canada, Japan for the following indications:

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

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+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Florida State University

Collaborator

Trials

234

Recruited

41,100+

Jim Scholefield

Florida State University

Chief Executive Officer since 2023

Bachelor of Science in Management from Florida State University

Dr. Stanley Iyadurai

Florida State University

Chief Medical Officer since 2023

MD and PhD from University of Minnesota