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)

Who is this study for? Patients with Bacterial Sexually Transmitted Diseases
What treatments are being studied? Doxycycline Hyclate
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Males, ≥ 18 years of age;

• Any sexual activity (i.e. oral sex, insertive or receptive anal sex, with or without a condom) with more than one male partner in the preceding 12 months;

• Intention to remain sexually active with more than one male partner in the next 12 months;

• At least one prior episode of a previously diagnosed and adequately treated syphilis, gonorrhea or chlamydia infection within 12 months prior to screening.

Locations
Other Locations
Canada
Sheldon Chumir Centre
RECRUITING
Calgary
St. Joseph's Healthcare Hamilton
NOT_YET_RECRUITING
Hamilton
McGill University Health Centre
RECRUITING
Montreal
The Ottawa Hospital
NOT_YET_RECRUITING
Ottawa
St. Michael's Hospital
RECRUITING
Toronto
BC Centre for Disease Control
RECRUITING
Vancouver
Contact Information
Primary
Saira Mohammed
smohammed@bccfe.ca
6047542171
Backup
Troy Grennan
troy.grennan@bccdc.ca
6047075606
Time Frame
Start Date: 2023-06-02
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 560
Treatments
Experimental: STI PrEP arm
doxycycline capsules 100mg orally daily for 12 months. Though the usual treatment dose of doxycycline is 100mg twice daily
Experimental: 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
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: Jonathan Troy Grennan

This content was sourced from clinicaltrials.gov