About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged ≥ 18 years.
Identifies as a man (cis or trans).
Has sex with men.
Able to provide informed consent.
Disqualifiers
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.
Trial population
Men-who-have-sex-with men aged ≥ 18 years living in the United Kingdom. Target of 108 participants, with minimum 40 participants living with HIV.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Detection of antimicrobial resistance genes of interest and characterisation of microbiome
The successful detection of antimicrobial resistance genes of interest (tetracycline and other antibiotic classes) and identification of bacterial species (microbiome) and in the oropharynx and gastrointestinal tract.
Secondary outcomes
Detection of differences in prevalence of antimicrobial resistance genes of interest between people using and not using antibiotic STI prophylaxis.
Detection of differences in microbiome between people using and not using antibiotic STI prophylaxis.
Change over time in prevalence of antimicrobial resistance genes of interest between people using and not using antibiotic STI prophylaxis.
Change over time in microbiome between people using and not using antibiotic STI prophylaxis.
Sponsors and contacts
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University College, London
Lead sponsor
University of Oxford
Collaborator