All studies
RecruitingNAINTERVENTIONAL

Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)

This research, called DISCO, is investigating new ways to prevent bacterial sexually transmitted infections (STIs) such as syphilis, chlamydia, and gonorrhoea. These infections are becoming more common, particularly among gay, bisexual, and other men who have sex with men. The study aims to find out if doxycycline, a type of antibiotic, can effectively prevent these STIs. It's comparing two approaches: taking doxycycline daily (this is called PrEP, or pre-exposure prophylaxis) versus taking it only after sex (called PEP, or post-exposure prophylaxis). The researchers will look at how well each method works, if it's safe, how it affects antibiotic resistance, and what the costs are. This could provide healthcare providers with another tool to help reduce STI rates.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Jonathan Troy Grennan
Enrolment target
560
Start
02 Jun 2023
Estimated completion
30 Jun 2027

What is this study about?

You might have heard that some sexually transmitted infections (STIs) are on the rise, particularly diseases like syphilis, chlamydia, and gonorrhoea. This is a concern because these infections can lead to serious health problems if not treated, and some are becoming harder to treat with existing medicines. We need new ways to protect people, especially those who are most affected.

This study, called DISCO, is looking at whether a common antibiotic called doxycycline could help prevent these bacterial STIs. It's focusing on gay, bisexual, and other men who have sex with men, as this group has seen a significant increase in these infections. The study wants to understand if taking doxycycline regularly, before potential exposure (this is often called PrEP, or pre-exposure prophylaxis) or taking it shortly after sex (this is called PEP, or post-exposure prophylaxis) can effectively stop these infections from developing.

The researchers will carefully compare these two ways of using doxycycline to see which is more effective at preventing STIs. They'll also check if the medicine is safe, if it causes any problems with antibiotics not working as well in the future (this is called antibiotic resistance), and what the overall costs are. The hope is that this research will give doctors and patients another option to help reduce the spread of STIs and keep people healthy.

Key takeaways

  • The study explores if doxycycline can prevent STIs like syphilis, gonorrhoea, and chlamydia.
  • It compares taking doxycycline daily versus only after sex.
  • It aims to find new ways to prevent STIs, especially for gay, bisexual, and other men who have sex with men.
  • The study will check how well the medicine works, if it's safe, and its effect on antibiotic resistance.
  • Participation would last about 15 months with regular check-ups and medical tests.

Who may be eligible?

To join this study, we are looking for men who are 18 years old or older. You should have had sex with more than one male partner in the last year, and plan to continue doing so in the next year. Also, you must have been diagnosed and treated for syphilis, gonorrhoea, or chlamydia at least once in the past 12 months.

There are some reasons why you might not be able to take part. For example, if you are allergic to doxycycline or similar medicines called tetracyclines, or if you are already taking doxycycline or other tetracycline medicines regularly for another health condition like acne.

You also can't participate if you're taking certain medicines that might interfere with how doxycycline works, or if you are currently using a medicine called isotretinoin. Importantly, anyone who could potentially become pregnant is not eligible for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you male and at least 18 years old?
  2. Have you had sex with more than one male partner in the last year, and plan to continue?
  3. Have you had syphilis, gonorrhoea, or chlamydia diagnosed and treated in the last 12 months?
  4. Are you NOT allergic to doxycycline or similar medicines?
  5. Are you NOT currently taking doxycycline or other specific medicines that might interfere with it?
  6. Are you NOT able to become pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would last for about 15 months (60 weeks). You would be randomly assigned to one of two groups: one group would take doxycycline every day, and the other would take doxycycline only after having sex.

You would have regular clinic visits over this time, where doctors would check on your health, ask about any symptoms or side effects, and carry out tests to see if you have developed any STIs. These visits would help the researchers understand how well the medication is working and if it is safe for you. You would also be asked about how easy or difficult it is to take the medication, to help understand how people might use it in everyday life.

Potential risks and benefits

Participating in this study could offer several potential benefits, such as receiving a potential new medication to help prevent STIs and having close medical monitoring throughout the study. This could lead to better health outcomes for you and contribute to knowledge that benefits others. However, as with any medication, there are potential risks, including side effects from doxycycline (such as stomach upset or sun sensitivity) and the possibility that the treatment might not perfectly prevent STIs. There's also a chance that using doxycycline could lead to bacteria becoming resistant to antibiotics over time. Your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your medical care.

Locations (6)

  • Sheldon Chumir Centre
    Verified postcode
    Calgary, Canada· Recruiting
  • BC Centre for Disease Control
    Verified postcode
    Vancouver, Canada· Recruiting
  • St. Joseph's Healthcare Hamilton
    Verified postcode
    Hamilton, Canada· Not yet recruiting
  • The Ottawa Hospital
    Verified postcode
    Ottawa, Canada· Not yet recruiting
  • St. Michael's Hospital
    Verified postcode
    Toronto, Canada· Recruiting
  • McGill University Health Centre
    Verified postcode
    Montreal, Canada· Recruiting

Common questions

What is a bacterial STI?

A bacterial STI is a sexually transmitted infection caused by bacteria, like syphilis, gonorrhoea, or chlamydia. These are usually treated with antibiotics.

What does 'PrEP' and 'PEP' mean?

PrEP (Pre-Exposure Prophylaxis) means taking medicine regularly to prevent an infection before you're exposed. PEP (Post-Exposure Prophylaxis) means taking medicine after a potential exposure to prevent an infection from taking hold.

Is doxycycline safe?

Doxycycline is a generally safe and commonly used antibiotic. However, like all medications, it can have side effects, which will be discussed with you by the study team.

Will taking part in the study affect my privacy?

All information collected about you during the study will be kept strictly confidential. Your name will not be linked to any study results.

What if I get an STI during the study?

If you get an STI during the study, the research team will ensure you receive appropriate and timely treatment, just as you would outside of the study.

How to find out more

Saira Mohammed

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Doxycycline Intervention for Bacterial STI ChemoprOphylaxis …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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