Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)

NCT ID: NCT04762134

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-02
• Study Completion Date: 2027-06-30

Brief 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.

Detailed Description

With the rising rates of STIs among gbMSM populations in Canada, there is an urgent need for novel interventions to prevent significant sequelae (e.g. neurosyphilis) and onward transmission of untreated infections. Despite longstanding public health efforts to encourage conventional strategies of STI prevention, gbMSM continue to bear the burden of syphilis which poses synergistic effects in the transmission of HIV. This study will add to this field through providing the first methodologically rigorous, prospective multicentre, open-label randomized controlled trial (RCT) of doxycycline-based STI PrEP (daily 100mg doxycycline) versus STI PEP (200mg doxycycline after exposure event) for the prevention of bacterial STIs among gbMSM over 15 months (60 weeks) of follow-up with adequate power to address drug efficacy in the prevention of bacterial STIs. Beyond the determination of efficacy, our trial will provide insight to the unique challenges of medication adherence through assessing the acceptability, tolerability and safety of therapy with doxycycline. This study aims to provide health care providers one additional tool to address the burden of STIs in populations with an increased likelihood of infection.

Conditions

Bacterial Sexually Transmitted Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

STI PrEP arm

doxycycline capsules 100mg orally daily for 12 months. Though the usual treatment dose of doxycycline is 100mg twice daily

Group Type: EXPERIMENTAL

Doxycycline Hyclate

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Doxycycline Hyclate

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Jonathan Troy Grennan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jonathan Troy Grennan

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Troy Grennan, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Sheldon Chumir Centre

Calgary, Alberta, Canada

Site Status: RECRUITING

BC Centre for Disease Control

Vancouver, British Columbia, Canada

Site Status: RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status: NOT_YET_RECRUITING

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: NOT_YET_RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Saira Mohammed

Role: CONTACT

smohammed@bccfe.ca

6047542171

Troy Grennan

Role: CONTACT

troy.grennan@bccdc.ca

6047075606

Facility Contacts

Grace Kwon

Role: primary

disco@ucalgary.ca

Ramin Azmin

Role: primary

6047075617

Kelly Waters

Role: primary

TBA

Role: primary

Reva Persaud

Role: primary

optionslab@unityhealth.to

Stanley Onyegbule

Role: backup

optionslab@unityhealth.to

Nathalie Paisible

Role: primary

nathalie.paisible@muhc.mcgill.ca

Turna Hortoglu

Role: backup

turna.hortoglu@muhc.mcgill.ca

Other Identifiers

BritishCCDC3

Identifier Type: -

Identifier Source: org_study_id