SPEAR
Research type
Research Study
Full title
STI Prophylaxis and Emergence of Antimicrobial Resistance
IRAS ID
330315
Contact name
Manik Kohli
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2023/09/15, UCL Data Protection
Duration of Study in the UK
2 years, 3 months, 25 days
Research summary
There growing research to show that the antibiotic doxycycline taken within 72 hours of sex without a condom can prevent the sexually transmitted infections (STIs) chlamydia, syphilis, and gonorrhoea in gay, bisexual, and other men-who-have-sex-with-men (MSM). This is called STI prophylaxis, doxycycline post-exposure prophylaxis (PEP), or 'doxyPEP'. It is not currently recommended in the UK, although new guidelines are expected. Surveys suggest that many MSM are already buying antibiotics online to take as STI prophylaxis. Possible risks include antibiotic resistance and changes in the bacteria normally present in our gut and throat – known as our microbiome. This study aims to investigate the risk of developing antibiotic resistance and the impact on the gut and throat microbiomes when people use antibiotics to prevent STIs; and to develop the tools to monitor this.
The study will collect throat swabs and stool samples from MSM, and use genome sequencing (which analyses DNA) to identify bacteria and look for evidence of antibiotic resistance. 108 MSM, with and without HIV, will be recruited from a sexual health clinic in London and online through social media and dating apps. At enrolment, participants will be split across three groups: 1) recently (<3 months) used antibiotics for STI prophylaxis; 2) recently (<3 months) taken antibiotics for STI treatment; or 3) not used any antibiotics recently (<3 months). Participants will attend 3 study visits over 12 months and will be asked to provide a throat swab, stool sample, and complete a questionnaire at each visit. The questionnaire will ask about demographics, health, sexual activity, and antibiotics. Participants will receive a £30 voucher for each visit.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
24/EM/0282
Date of REC Opinion
13 Dec 2024
REC opinion
Favourable Opinion