Doxycycline for STDs Prevention

(foXXxy doxy Trial)

Recruiting at 11 trial locations

Overseen By Nancy Liu

Age: < 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Westat

Must not be taking: Barbiturates, Phenytoin, Lithium, others

Disqualifiers: Male, Pregnant, Tetracycline allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

760 Participants Needed

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

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

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 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

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+