STI Prophylaxis and Emergence of Antimicrobial Resistance

NCT06778083 | Recruiting

• 2 other identifiers: 174194REC Ref: 24/EM/0282
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

DoxyPEP; STI Prophylaxis; Doxycycline; STI Prevention; Antimicrobial Resistance; Antibiotic Resistance; Microbiome; Men-who-have-sex-with-men

Outcome Measures

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.

  From enrolment to 12 months

Secondary Outcomes (4)

• 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

• 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

Study Arms (3)

DoxyPEP users

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

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 antibiotics

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men-who-have-sex-with-men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• University of Oxford: collaborator

Study Sites (1)

Central and North West London NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (6)

• Kohli M, Reid D, Pulford CV, Howarth A, Brown J, Mohammed H, Hughes G, Mercer CH, Saunders J. Choice of antibiotics for prophylaxis of bacterial STIs among individuals currently self-sourcing. Sex Transm Infect. 2022 Mar;98(2):158. doi: 10.1136/sextrans-2021-055310. Epub 2021 Dec 6. No abstract available.

  PMID: 34873029 BACKGROUND

• Kohli M, Medland N, Fifer H, Saunders J. BASHH updated position statement on doxycycline as prophylaxis for sexually transmitted infections. Sex Transm Infect. 2022 May;98(3):235-236. doi: 10.1136/sextrans-2022-055425. No abstract available.

  PMID: 35414633 BACKGROUND

• Chu VT, Glascock A, Donnell D, Grabow C, Brown CE, Ward R, Love C, Kalantar KL, Cohen SE, Cannon C, Woodworth MH, Kelley CF, Celum C, Luetkemeyer AF, Langelier CR. Impact of doxycycline post-exposure prophylaxis for sexually transmitted infections on the gut microbiome and antimicrobial resistome. Nat Med. 2025 Jan;31(1):207-217. doi: 10.1038/s41591-024-03274-2. Epub 2024 Oct 3.

  PMID: 39363100 BACKGROUND

• Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bebear C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Dore V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.

  PMID: 29229440 BACKGROUND

• Molina JM, Bercot B, Assoumou L, Rubenstein E, Algarte-Genin M, Pialoux G, Katlama C, Surgers L, Bebear C, Dupin N, Ouattara M, Slama L, Pavie J, Duvivier C, Loze B, Goldwirt L, Gibowski S, Ollivier M, Ghosn J, Costagliola D; ANRS 174 DOXYVAC Study Group. Doxycycline prophylaxis and meningococcal group B vaccine to prevent bacterial sexually transmitted infections in France (ANRS 174 DOXYVAC): a multicentre, open-label, randomised trial with a 2 x 2 factorial design. Lancet Infect Dis. 2024 Oct;24(10):1093-1104. doi: 10.1016/S1473-3099(24)00236-6. Epub 2024 May 23.

  PMID: 38797183 BACKGROUND

• Luetkemeyer AF, Donnell D, Dombrowski JC, Cohen S, Grabow C, Brown CE, Malinski C, Perkins R, Nasser M, Lopez C, Vittinghoff E, Buchbinder SP, Scott H, Charlebois ED, Havlir DV, Soge OO, Celum C; DoxyPEP Study Team. Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections. N Engl J Med. 2023 Apr 6;388(14):1296-1306. doi: 10.1056/NEJMoa2211934.

  PMID: 37018493 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Oropharyngeal Swab 2. Stool Sample Samples will undergo bacterial DNA extraction and host cell depletion, following by metagenomic sequencing.

MeSH Terms

Conditions

Sexually Transmitted Diseases; Homosexuality

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior

Central Study Contacts

Manik Kohli, MBChB MSc

CONTACT

+4420276794466; m.kohli@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)