STI Prophylaxis and Emergence of Antimicrobial Resistance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity College, London

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

108 Participants
are grouped into 3 trial groups
Group A: DoxyPEP users
Group B: Doxycycline treatment
Group C: No antibiotics

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrolment to 12 months

Secondary outcomes

1

Detection of differences in prevalence of antimicrobial resistance genes of interest between people using and not using antibiotic STI prophylaxis.

Time frame
From enrolment to 12 months
2

Detection of differences in microbiome between people using and not using antibiotic STI prophylaxis.

Time frame
From enrolment to 12 months
3

Change over time in prevalence of antimicrobial resistance genes of interest between people using and not using antibiotic STI prophylaxis.

Time frame
From enrolment to 12 months
4

Change over time in microbiome between people using and not using antibiotic STI prophylaxis.

Time frame
From enrolment to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College, London

Lead sponsor

University of Oxford

Collaborator