Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: Male

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 definitively assess the efficacy, safety, antimicrobial resistance profiles and costs associated with doxycycline-based STI prevention

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonathan Troy Grennan
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Doxycycline

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.