About the Study

Doxycycline is a commonly used and widely accepted antibiotic for acne treatment and malaria prophylaxis. Three small studies have indicated that doxycycline may also be beneficial in preventing bacterial STIs, and could be used as STI pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP). However, definitive data about the acceptability, safety, and efficacy of doxycycline use for STI prevention is needed.

CTN 329 is the first methodologically rigorous randomized controlled trial investigating the use of doxycycline in the prevention of bacterial STIs (syphilis, gonorrhea, or chlamydia) among gay, bisexual, and other men who have sex with men (gbMSM) and transgender women.

About the Disease

Canada has seen an increase in bacterial STIs of more than 160 per cent over the last decade. In Canada, syphilis rates are at a record high, with two-thirds of cases in urban centres identified among gbMSM living with HIV. Gonorrhea and chlamydia also disproportionately affect gbMSM. With high reinfection rates, gbMSM are at risk of developing complications such as antimicrobial resistance, meaning treatments may become less effective.

In addition, people living with HIV can be at a higher risk for more serious STI complications. For example, people coinfected with HIV and syphilis are more likely to progress to neurosyphilis, where the syphilis bacteria infect the brain and spinal cord, damaging the nervous system. There is also evidence that being infected with a bacterial STI could increase risk of HIV transmission.

Given the significant rise in STI cases and the potential development of complications, novel STI prevention strategies are needed.

Study Approach

A total of 447 participants will be recruited from nine clinical sites in Vancouver, Calgary, Toronto, Hamilton, Ottawa, and Montreal. The participants will be separated into three arms: the STI PrEP arm will take 100mg doxycycline daily; the STI PEP arm will take 200mg doxycycline within 24–72 hours after an at-risk sexual encounter (condomless or oral sex); and the control/standard of care arm will undergo routine STI screening and care (i.e., sexual health and STI education, condoms, risk reduction counselling, and comprehensive STI testing).

Once recruited, each participant will receive their allocated intervention for 48 weeks and be followed for 60 weeks. They will need to attend study visits at baseline and weeks 4, 12, 24, 36, 48, and 60. These visits will include an adverse event assessment, routine bloodwork, STI screening, adherence assessment, evaluation of antimicrobial resistance, and questionnaires on sexual risk behaviour and substance use.

Eligibility Requirements

Inclusion Criteria

  1. Adults, ≥ 18 years of age
  2. Gay. bisexual and other men who have sex with men (both cisgender and transgender) or transgender women
  3. 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 previous 12 months
  4. Intention to remain sexually active with more than one male partner in the next 12 months
  5. At least one prior episode of a previously diagnosed and adequately treated syphilis, gonorrhea, or chlamydia infection within 12 months prior to screening
  6. If you are capable of becoming pregnant, you will use birth control/contraception reliably (if you are sexually active) during the entire study duration

Both HIV-positive and HIV-negative participants will be enrolled.

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 that could lower doxycycline levels, including barbiturates, phenytoin and carbamazepine
  4. Individuals currently using isotretinoin
  5. Will not use birth control/contraception reliably during the course of the study duration – if capable of becoming pregnant

Additional Information

Study website: www.godisco.ca

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Dr. Ann Burchell

Co-Leader, Co-infections and Related Conditions Core; Member, Steering Committee

St. Michael’s Hospital

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CTN Investigator Dr. Troy Grennan
CTN Investigator Dr. Troy Grennan

Dr. Troy Grennan

Co-Leader, Co-Infections and Related Conditions; Member, Steering Committee

BC Centre for Disease Control

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Participating Sites

Here’s where this study is being conducted.

Hamilton Health Sciences - Special Immunology Services (SIS) Clinic

Hamilton, ON

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