STI Prophylaxis and Emergence of Antimicrobial Resistance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-10

Study Completion Date

2027-04-30

Brief Summary

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The goal of this observational study is to understand the risk of antibiotic resistance and changes in the human microbiome (bacteria that live inside and on us), if people use antibiotics to prevent sexually transmitted infections (STI prophylaxis, doxycycline post-exposure prophylaxis, or 'doxyPEP'). The study will assess how easy and acceptable it is to find antibiotic resistance and microbiome changes in the throats and guts of men-who-have-sex-with-men (MSM) who use STI prophylaxis.

The study will recruit 108 MSM who are using and not using STI prophylaxis. Participants will visit the clinic every 6 months. At each visit, they will provide a throat swab and stool sample, and complete a questionnaire. DNA of the bacteria from the samples will be analysed to identify the bacteria and look for antibiotic resistance.

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Detailed Description

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Conditions

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Sexually Transmitted Infection (STI) Prevention Antibiotic Prophylaxis Antibiotic Resistance, Bacterial Microbiome Doxycycline

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DoxyPEP users

Previous use of doxycycline post-exposure prophylaxis within 3 months of baseline visit.

No interventions assigned to this group

Doxycycline treatment

Previous use of doxycycline for STI treatment within 3 months of baseline visit.

Once enrolled all participants may use doxycycline post-exposure prophylaxis.

No interventions assigned to this group

No antibiotics

No antibiotics within previous 3 months of baseline visit. Once enrolled all participants may use doxycycline post-exposure prophylaxis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged ≥ 18 years.
* Identifies as a man (cis or trans).
* Has sex with men.
* Able to provide informed consent.

Exclusion Criteria

* Use of an antibiotic other than doxycycline in the 3 months prior to enrolment
* Currently being treated for an STI with doxycycline
* Use of doxycycline within the prior 3 months for an indication other than STI treatment or STI prevention.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes