Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain

Overview

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.

Interventions

• Other No Intervention: Observational Cohort
  No Intervention: Observational Cohort

Primary outcome measures

• STI predictive model [Time frame: through study completion, an average of 5 years]

Secondary outcome measures (11)

• STI incidence [Time frame: through study completion, an average of 5 years]
• STI dynamics [Time frame: through study completion, an average of 5 years]
• asymptomatic STIs [Time frame: through study completion, an average of 5 years]
• behavioral changes [Time frame: through study completion, an average of 5 years]
• DOXYPEP [Time frame: through study completion, an average of 5 years]
• PrEP discontinuation [Time frame: through study completion, an average of 5 years]
• Predictor of PrEP discontinuation [Time frame: through study completion, an average of 5 years]
• PrEP adherence [Time frame: through study completion, an average of 5 years]
• Time to discontinuation [Time frame: through study completion, an average of 5 years]
• HIV incident infection [Time frame: through study completion, an average of 5 years]
• HIV incident infection [Time frame: through study completion, an average of 5 years]

Eligibility criteria

Inclusion criteria

• All individuals with documented initiation of oral PrEP (daily or event-driven regimens), 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. Available at http://.gesida-seimc.org/category/guias-clinicas/otras-guias-vigentes/), are as follows:

• People without HIV infection at the time of cohort inclusion
• Age ≥ 16 yr who meet the following criteria:
• MSM and transgender women with at least two of the following criteria during the last year: > 10 sexual partners; Condomless anal sex; Chemsex; PEP; ≥ 1 STI
• Sex worker women who report non-habitual use of condoms.
• Cisgender males/females, who report condomless and present at least two of the same criteria as MSM and transgender.
• PWID with unsafe injection practices

Exclusion Criteria: none

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Spain · 26 centers

• Hospital Universitario de Torrecárdenas — Almería
• Hospital Universitario Puerto Real — Cadiz
• Hospital Universitario Santa Lucía — Cartagena
• hospital Universitario reina Sofía — Córdoba
• Hospital Virgen de la Luz — Cuenca
• Hospital Universitario de Elche — Elche
• Hospital Clínico Universitario San Cecilio — Granada
• Hospital Universitario Virgen de las Nieves — Granada
• … and 18 more centers

Publications

• 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. PMID 35584898
• 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. PMID 32205724
• 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. PMID 33431605
• 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/jamanetw PMID 33355675
• 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. PMID 29509889
• 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 PMID 38492988
• 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 PMID 35643090
• 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 Incidenc PMID 30964528

Identifiers

NCT: NCT06860945 · STI_PrEP24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗