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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy.
Methods: Ambispective cohort study, multicentric (23 Spanish hospitals). All PrEP users, with follow-up within the program, will be included. Entry into the program will be considered as the baseline visit. From there, patients are followed quarterly, following the national protocols for monitoring PrEP users in Spain. At each visit, diagnosis of different STIs (serum, pharyngeal swab, urethral or urine sample, rectal swab, endocervical/vaginal swab, ulcer) is performed. Primary outcome variable: development of an STI (Yes/No). The following STIs will be considered: syphilis, Neisseria gonorrhoeae (NG) infection, Chlamydia trachomatis (CT) infection, lymphogranuloma venereum (LGV), Mycoplasma genitalium (MG) infection, genital herpes, hepatitis A, hepatitis B, hepatitis C, HIV infection, and MPOX. Secondary outcome variable: number of diagnosed STIs. In order to determine factors associated with acquiring an STI, multivariate analyses will be conducted using logistic regression. The best models will be analyzed in the validation population. To compare the models, we will follow the Bayesian approach suggested by Benavoli et al.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STI_PrEPare | All individuals with documented initiation of daily oral PrEP, who have collected the medication at least once and have taken at least one pill, will be included in the study. The approved criteria for the use of oral PrEP in Spain, as recommended by the Spanish Gesida guidelines (GeSIDA. Recomendaciones sobre la Profilaxis Pre-Exposición para la Prevención de la Infección por VIH en España. Marzo 2023. Disponible en http://.gesida-seimc.org/category/guias-clinicas/otras-guias-vigentes/), are as follows:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No Intervention: Observational Cohort |
|
| Measure | Description | Time Frame |
|---|---|---|
| STI predictive model | Predictive model for the acquisition of sexually transmitted infections in individuals using PrEP within the national provision program for this strategy | through study completion, an average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| STI incidence | Incidence of sexually transmitted infections (STIs) in the cohort globally and by type of infection. | through study completion, an average of 5 years |
| STI dynamics | Evolution of STI diagnoses during follow-up among PrEP users included in the study, both globally and by specific pathogen |
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Inclusion Criteria:
The approved criteria for the use of oral PrEP in Spain, as recommended by the Spanish Gesida guidelines (GeSIDA. Recomendaciones sobre la Profilaxis Pre-Exposición para la Prevención de la Infección por VIH en España. Marzo 2023. Available at http://.gesida-seimc.org/category/guias-clinicas/otras-guias-vigentes/), are as follows:
Exclusion Criteria: none
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All individuals who meet the criteria for PrEP use in Spain, are over 16 years old, and have taken at least one pill.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anaïs Corma-Gómez | Contact | +34676170692 | anais.corgo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Anaïs Corma-Gómez, MD, PhD | Hospital Clínico Universitario de Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Torrecárdenas | Recruiting | Almería | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35584898 | Background | Jongen VW, Zimmermann HML, Goedhart M, Bogaards JA, Davidovich U, Coyer L, de Vries HJC, Prins M, Hoornenborg E, Schim van der Loeff MF; Amsterdam PrEP Project team in the HIV Transmission Elimination Amsterdam (H-TEAM) Initiative. Can we screen less frequently for STI among PrEP users? Assessing the effect of biannual STI screening on timing of diagnosis and transmission risk in the AMPrEP Study. Sex Transm Infect. 2023 May;99(3):149-155. doi: 10.1136/sextrans-2022-055439. Epub 2022 May 18. | |
| 32205724 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2025 |
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| through study completion, an average of 5 years |
| asymptomatic STIs | Proportion of asymptomatic STIs diagnosed within the screening program. | through study completion, an average of 5 years |
| behavioral changes | Sexual risk behaviors of individuals in the cohort, before and after initiating PrEP | through study completion, an average of 5 years |
| DOXYPEP | Proportion of Individuals who might benefit from the 'Doxy-PEP' strategy (doxycycline use as post-exposure prophylaxis for chlamydia and syphilis) | through study completion, an average of 5 years |
| PrEP discontinuation | Prevalence of oral PrEP discontinuation within a nationwide PrEP users' cohort. | through study completion, an average of 5 years |
| Predictor of PrEP discontinuation | Predictors of oral PrEP discontinuation within a nationwide PrEP users' cohort. | through study completion, an average of 5 years |
| PrEP adherence | Self-reported oral PrEP adherence. | through study completion, an average of 5 years |
| Time to discontinuation | Time elapsed between oral PrEP initiation and oral PrEP discontinuation. | through study completion, an average of 5 years |
| HIV incident infection | Incidence of HIV seroconversions | through study completion, an average of 5 years |
| HIV incident infection | Profiles of those who acquire HIV while taking oral PrEP. | through study completion, an average of 5 years |
| Hospital Universitario Puerto Real | Recruiting | Cadiz | Spain |
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| Hospital Universitario Santa Lucía | Recruiting | Cartagena | Spain |
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| hospital Universitario reina Sofía | Recruiting | Córdoba | Spain |
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| Hospital Virgen de la Luz | Recruiting | Cuenca | Spain |
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| Hospital Universitario de Elche | Recruiting | Elche | Spain |
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| Hospital Clínico Universitario San Cecilio | Recruiting | Granada | Spain |
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| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | Spain |
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| Hospital Universitario Juan Ramón Jiménez | Recruiting | Huelva | Spain |
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| Complejo Hospitalario de Jaén | Recruiting | Jaén | Spain |
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| Hospital de Jerez de la Frontera | Recruiting | Jerez de la Frontera | Spain |
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| Hospital Universitario de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Spain |
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| Hospital Universitario Dr. Negrín | Recruiting | Las Palmas de Gran Canaria | Spain |
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| Centro Sanitario Sandoval | Recruiting | Madrid | Spain |
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| Hospital Fundación Jiménez Díaz | Recruiting | Madrid | Spain |
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| Hospital Universitario Infanta Leonor | Recruiting | Madrid | Spain |
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| Hospital Universitario La Princesa | Recruiting | Madrid | Spain |
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| Hospital Regional Universitario de Málaga | Recruiting | Málaga | Spain |
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| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | Spain |
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| Hospital Universitario Virgen de la Arrixaca | Recruiting | Murcia | Spain |
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| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Spain |
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| Hospital Universitario Virgen de la Macarena | Recruiting | Seville | Spain |
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| Hospital Universitario Virgen de Valme | Recruiting | Seville | Spain |
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| Hospital Universitario Virgen del Rocío | Recruiting | Seville | Spain |
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| Hospital Universitario de Valladolid | Recruiting | Valladolid | Spain |
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| Hospital Universitario Álvaro Cunqueiro | Recruiting | Vigo | Spain |
|
| Background |
| Tang EC, Vittinghoff E, Philip SS, Doblecki-Lewis S, Bacon O, Chege W, Coleman ME, Elion R, Buchbinder S, Kolber MA, Liu AY, Cohen SE. Quarterly screening optimizes detection of sexually transmitted infections when prescribing HIV preexposure prophylaxis. AIDS. 2020 Jul 1;34(8):1181-1186. doi: 10.1097/QAD.0000000000002522. |
| 33431605 | Background | van Wifferen F, Hoornenborg E, Schim van der Loeff MF, Heijne J, van Hoek AJ. Cost-effectiveness of two screening strategies for Chlamydia trachomatis and Neisseria gonorrhoeae as part of the PrEP programme in the Netherlands: a modelling study. Sex Transm Infect. 2021 Dec;97(8):607-612. doi: 10.1136/sextrans-2020-054741. Epub 2021 Jan 11. |
| 33355675 | Background | McManus H, Grulich AE, Amin J, Selvey C, Vickers T, Bavinton B, Zablotska I, Vaccher S, Jin F, Holden J, Price K, Yeung B, Cabrera Quichua G, Ogilvie E, McNulty A, Smith D, Guy R. Comparison of Trends in Rates of Sexually Transmitted Infections Before vs After Initiation of HIV Preexposure Prophylaxis Among Men Who Have Sex With Men. JAMA Netw Open. 2020 Dec 1;3(12):e2030806. doi: 10.1001/jamanetworkopen.2020.30806. |
| 29509889 | Background | Traeger MW, Schroeder SE, Wright EJ, Hellard ME, Cornelisse VJ, Doyle JS, Stoove MA. Effects of Pre-exposure Prophylaxis for the Prevention of Human Immunodeficiency Virus Infection on Sexual Risk Behavior in Men Who Have Sex With Men: A Systematic Review and Meta-analysis. Clin Infect Dis. 2018 Aug 16;67(5):676-686. doi: 10.1093/cid/ciy182. |
| 38492988 | Background | Ayerdi O, Orviz E, Valls Carbo A, Fernandez Pineiro N, Vera Garcia M, Puerta Lopez T, Ballesteros Martin J, Rodriguez Martin C, Baza Caraciolo B, Lejarraga Canas C, Perez-Garcia JA, Carrio D, Garcia Lotero M, Ferreras Forcada M, Gonzalez Polo M, Raposo Utrilla M, Delgado-Iribarren A, Del Romero-Guerrero J, Estrada Perez V. Incidence of sexually transmitted infections and screening models among pre-exposure prophylaxis users. Enferm Infecc Microbiol Clin (Engl Ed). 2024 Dec;42(10):570-576. doi: 10.1016/j.eimce.2024.03.004. Epub 2024 Mar 16. |
| 35643090 | Background | Traeger MW, Guy R, Asselin J, Patel P, Carter A, Wright EJ, Grulich A, McManus H, Fairley CK, Chow EPF, McNulty A, Finlayson R, Bell C, Owen L, Marshall L, Russell D, O'Donnell D, Donovan B, Hellard ME, Stoove MA; Australian Collaboration for Coordinated Enhanced Sentinel Surveillance of Sexually Transmissible Infections and Blood Borne Viruses (ACCESS) Study Group. Real-world trends in incidence of bacterial sexually transmissible infections among gay and bisexual men using HIV pre-exposure prophylaxis (PrEP) in Australia following nationwide PrEP implementation: an analysis of sentinel surveillance data. Lancet Infect Dis. 2022 Aug;22(8):1231-1241. doi: 10.1016/S1473-3099(22)00175-X. Epub 2022 May 25. |
| 30964528 | Background | Traeger MW, Cornelisse VJ, Asselin J, Price B, Roth NJ, Willcox J, Tee BK, Fairley CK, Chang CC, Armishaw J, Vujovic O, Penn M, Cundill P, Forgan-Smith G, Gall J, Pickett C, Lal L, Mak A, Spelman TD, Nguyen L, Murphy DA, Ryan KE, El-Hayek C, West M, Ruth S, Batrouney C, Lockwood JT, Hoy JF, Hellard ME, Stoove MA, Wright EJ; PrEPX Study Team. Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection. JAMA. 2019 Apr 9;321(14):1380-1390. doi: 10.1001/jama.2019.2947. |
| 31178284 | Background | Hoornenborg E, Coyer L, Achterbergh RCA, Matser A, Schim van der Loeff MF, Boyd A, van Duijnhoven YTHP, Bruisten S, Oostvogel P, Davidovich U, Hogewoning A, Prins M, de Vries HJC; Amsterdam PrEP Project team in the HIV Transmission Elimination AMsterdam (H-TEAM) Initiative. Sexual behaviour and incidence of HIV and sexually transmitted infections among men who have sex with men using daily and event-driven pre-exposure prophylaxis in AMPrEP: 2 year results from a demonstration study. Lancet HIV. 2019 Jul;6(7):e447-e455. doi: 10.1016/S2352-3018(19)30136-5. Epub 2019 Jun 6. |
| 34310371 | Background | Drak D, Mcmanus H, Vickers T, Heron JE, Vaccher S, Zablotska I, Guy R, Bavinton B, Jin F, Grulich AE, Bloch M, O'Connor CC, Gracey DM; Expanded PrEP Implementation in Communities New South Wales (EPIC-NSW) research group. Renal impairment in a large-scale HIV preexposure prophylaxis implementation cohort. AIDS. 2021 Nov 15;35(14):2319-2326. doi: 10.1097/QAD.0000000000003035. |
| 22784037 | Background | Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11. |
| 25065857 | Background | Grant RM, Anderson PL, McMahan V, Liu A, Amico KR, Mehrotra M, Hosek S, Mosquera C, Casapia M, Montoya O, Buchbinder S, Veloso VG, Mayer K, Chariyalertsak S, Bekker LG, Kallas EG, Schechter M, Guanira J, Bushman L, Burns DN, Rooney JF, Glidden DV; iPrEx study team. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis. 2014 Sep;14(9):820-9. doi: 10.1016/S1473-3099(14)70847-3. Epub 2014 Jul 22. |
| 21091279 | Background | Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23. |
| Feb 24, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2024 | Feb 24, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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