Antibiotic Prophylaxis, Antibiotic Resistance, Bacterial, Doxycycline, Microbiome, Sexually Transmitted Infection (STI) Prevention
Conditions
Keywords
DoxyPEP, STI Prophylaxis, Doxycycline, STI Prevention, Antimicrobial Resistance, Antibiotic Resistance, Microbiome, Men-who-have-sex-with-men
Brief summary
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.
Interventions
None listed
Sponsors
University of Oxford
University College, London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of antimicrobial resistance genes of interest and characterisation of microbiome | From enrolment to 12 months | 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
| Measure | Time frame |
|---|---|
| Change over time in prevalence of antimicrobial resistance genes of interest between people using and not using antibiotic STI prophylaxis. | From enrolment to 12 months |
| Change over time in microbiome between people using and not using antibiotic STI prophylaxis. | From enrolment to 12 months |
| Detection of differences in prevalence of antimicrobial resistance genes of interest between people using and not using antibiotic STI prophylaxis. | From enrolment to 12 months |
| Detection of differences in microbiome between people using and not using antibiotic STI prophylaxis. | From enrolment to 12 months |
Countries
United Kingdom
Contacts
Primary ContactManik Kohli, MBChB MSc
Outcome results
None listed