Doxycycline for STDs Prevention
(foXXxy doxy Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether doxycycline, an antibiotic, can prevent bacterial sexually transmitted infections (STIs) such as gonorrhea, chlamydia, or early syphilis in young women. Participants will either take doxycycline after unprotected sex, take it weekly, or follow standard STI testing and health counseling. The trial aims to evaluate the effectiveness, acceptability, and impact on antibiotic resistance of these methods to guide public health decisions. Young women who have had unprotected sex and a recent STI diagnosis may be suitable for this study. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved doxycycline can benefit more patients, offering participants a chance to contribute to important public health insights.
Will I have to stop taking my current medications?
If you are taking medications that interact with doxycycline, like barbiturates, phenytoin, lithium, carbamazepine, systemic retinoids, or warfarin, you may need to stop them to participate in the trial. The trial does not specify other medications, so it's best to discuss your current medications with the study team.
What is the safety track record for doxycycline?
Previous studies have shown that doxycycline is safe for use. Research indicates that taking 200 mg of doxycycline after sex can significantly reduce the risk of certain bacterial STIs, such as syphilis and chlamydia, by more than 70%. This suggests the treatment is generally well-tolerated with few issues.
The studies report no serious side effects, indicating most people can take the medication without problems. Some might experience mild side effects like an upset stomach or increased sensitivity to the sun, which can lead to easier sunburn. These side effects are usually not severe and tend to resolve on their own.
Overall, doxycycline has been used safely for a long time, even for other conditions, making it a reliable option for preventing STIs.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for STD prevention because they offer innovative approaches compared to traditional methods like condoms and regular STI testing. The on-demand doxyPEP involves taking doxycycline within 72 hours after unprotected sex, potentially offering a proactive way to prevent infections right after exposure. Meanwhile, the weekly doxycycline option provides consistent protection, regardless of sexual activity, adding a preventative layer similar to how some medications are used for other health conditions like malaria prophylaxis. These approaches could revolutionize STD prevention by providing more flexible and user-friendly options.
What evidence suggests that doxycycline might be an effective treatment for preventing STIs?
Research has shown that doxycycline can effectively prevent bacterial sexually transmitted infections (STIs). In this trial, participants in one arm will take doxycycline within 72 hours after unprotected sex. Studies have found that this approach greatly lowers the risk of contracting STIs like syphilis and chlamydia. For instance, one study discovered that the number of these infections dropped by two-thirds compared to usual care. Another arm of this trial involves taking doxycycline once a week, which has also shown promise in reducing STI rates. These findings suggest that doxycycline could be a strong option for preventing certain STIs when used correctly.678910
Who Is on the Research Team?
Jenell Stewart, DO, MPH
Principal Investigator
Hennepin Healthcare
Cherie Blaire, MD, PhD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, including STI testing and resistance testing
What Are the Treatments Tested in This Trial?
Interventions
- Doxycycline
Doxycycline is already approved in United States, European Union, Canada, Japan for the following indications:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
- 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
National Institute of Allergy and Infectious Diseases (NIAID)/Division of AIDS (DAIDS)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institutes of Health (NIH)
Collaborator
Florida State University
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
The Office of the Director, National Institutes of Health (NIH)
Collaborator