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RECRUITING
NCT04762134
NA

Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)

Sponsor: Jonathan Troy Grennan

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

560

Start Date

2023-06-02

Completion Date

2027-06-30

Last Updated

2024-08-05

Healthy Volunteers

No

Interventions

DRUG

Doxycycline 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