RecruitingNot ApplicableNCT04762134

Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)

A Randomized Trial of Doxycycline Chemoprophylaxis for the Prevention of Sexually Transmitted Infections in Gay, Bisexual and Other Men Who Have Sex With Men (gbMSM)


Sponsor

Jonathan Troy Grennan

Enrollment

560 participants

Start Date

Jun 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

There is a growing epidemic of the bacterial sexually transmitted infections (STIs) syphilis, chlamydia and gonorrhea worldwide; similarly concerning trends have been noted in Canada, where increases of over 160% have been seen in bacterial STIs over the last decade. In Canada, gay, bisexual, and other men who have sex with men (gbMSM) - including those living with HIV - are disproportionately impacted by bacterial STIs5,6These dramatic increases in bacterial STIs, the potential development of serious complications including AMR, and waning effectiveness of the promotion of conventional STI prevention tools (e.g. condoms), signals the need for novel STI prevention strategies and tools to mitigate STI-related complications. A rigorous randomized controlled trial will be conducted to compare STI PrEP vs. STI PEP and definitively assess the efficacy, safety, antimicrobial resistance profiles and costs associated with doxycycline-based STI prevention.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Canadian study is testing whether a daily antibiotic called doxycycline (taken before exposure) or a higher dose taken after sexual contact can prevent bacterial sexually transmitted infections (STIs) — including syphilis, chlamydia, and gonorrhea — in gay, bisexual, and other men who have sex with men (gbMSM). Rates of these STIs have surged dramatically in Canada, and this trial is the first large, rigorous study comparing the two doxycycline strategies over 15 months. Men aged 18 and older who have had more than one male partner in the past year and have had at least one bacterial STI in the past 12 months are eligible, though those allergic to tetracyclines or unable to become pregnant are excluded. Participation involves taking a daily or post-exposure pill and attending regular clinic visits for STI testing and safety monitoring. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDoxycycline Hyclate

STI PrEP arm: doxycycline capsules 100mg orally daily for 12 months STI PEP arm: doxycycline 200mg orally once within 24-72 hours following each sexual encounter deemed at risk (i.e. condomless anal or oral sex), to a maximum of six pills (i.e. 600 mg total) per week


Locations(6)

Sheldon Chumir Centre

Calgary, Alberta, Canada

BC Centre for Disease Control

Vancouver, British Columbia, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

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NCT04762134