Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)
Bacterial Sexually Transmitted DiseasesThere 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.
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Participation Requirements
-
Sex:
MALE -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
1. Males, ≥ 18 years of age;
2. 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;
3. Intention to remain sexually active with more than one male partner in the next 12 months;
4. At least one prior episode of a previously diagnosed and adequately treated syphilis, gonorrhea or chlamydia infection within 12 months prior to screening.
Exclusion Criteria:
1. Known allergy to doxycycline or tetracyclines;
2. Existing chronic or intermittent tetracycline or doxycycline use (e.g. for chronic osteomyelitis, acne).
3. Use of medications which could lower doxycycline levels, including barbiturates, phenytoin and carbamazepine.
4. Individuals currently using isotretinoin;
5. Any individual capable of becoming pregnant.
Study Location
Sheldon Chumir Centre
Sheldon Chumir CentreCalgary, Alberta
Canada
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St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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TBA
BC Centre for Disease Control
BC Centre for Disease ControlVancouver, British Columbia
Canada
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Ramin Azmin
6047075617McGill University Health Centre
McGill University Health CentreMontréal, Quebec
Canada
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St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare HamiltonHamilton, Ontario
Canada
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Kelly Waters
- Study Sponsored By
- British Columbia Centre for Disease Control
- Participants Required
- More Information
- Study ID:
NCT04762134