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| ID | Type | Description | Link |
|---|---|---|---|
| REC Ref: 24/EM/0282 | Other Identifier | NHS Health Research Authority |
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| Name | Class |
|---|---|
| University of Oxford | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Men-who-have-sex-with-men
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manik Kohli, MBChB MSc | Contact | +4420276794466 | m.kohli@ucl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central and North West London NHS Foundation Trust | Recruiting | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34873029 | Background | 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. | |
| 35414633 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2024 | Jan 8, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Samples will undergo bacterial DNA extraction and host cell depletion, following by metagenomic sequencing.
| 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 |
| 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. |
| 39363100 | 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. |
| 29229440 | 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. |
| 38797183 | 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. |
| 37018493 | 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |