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Anti-bacterial

Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections (foXXxy doxy Trial)

Phase 3

Waitlist Available

Research Sponsored by Westat

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Age 13-29 years, inclusive;

* Who were AFAB, independent of gender identity;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one (1) year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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 people who were assigned female at birth (AFAB) while also evaluating acceptability and antimicrobial resistance in order to inform public health policy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Doxycycline may cause side effects such as stomach upset, diarrhea, nausea, or vomiting. Sun sensitivity could also increase with its use. Long-term use might lead to more serious issues like liver damage or yeast infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one (1) year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one (1) year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one (1) year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Combined incidence of GC, CT, and/or early syphilis infection

Secondary study objectives

Individual incidence diagnoses of GC, CT, and early syphilis infection

Other study objectives

Acceptability and optimism

Adherence to doxycycline

First occurrence of a bacterial STI

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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/front hole, 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.

0 / 7Eligibility criteria met