HIV, PrEP, Sexually Transmitted Infections (STIs)
Conditions
Keywords
STI, HIV, PrEP, modelling, machine learning, adherence, persistence
Brief summary
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
OTHERNo Intervention: Observational Cohort
No Intervention: Observational Cohort
Sponsors
Instituto de Salud Carlos III
Hospital Universitario de Valme
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| STI predictive model | through study completion, an average of 5 years | Predictive model for the acquisition of sexually transmitted infections in individuals using PrEP within the national provision program for this strategy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| STI dynamics | through study completion, an average of 5 years | Evolution of STI diagnoses during follow-up among PrEP users included in the study, both globally and by specific pathogen |
| asymptomatic STIs | through study completion, an average of 5 years | Proportion of asymptomatic STIs diagnosed within the screening program. |
| behavioral changes | through study completion, an average of 5 years | Sexual risk behaviors of individuals in the cohort, before and after initiating PrEP |
| DOXYPEP | through study completion, an average of 5 years | Proportion of Individuals who might benefit from the 'Doxy-PEP' strategy (doxycycline use as post-exposure prophylaxis for chlamydia and syphilis) |
| STI incidence | through study completion, an average of 5 years | Incidence of sexually transmitted infections (STIs) in the cohort globally and by type of infection. |
| Predictor of PrEP discontinuation | through study completion, an average of 5 years | Predictors of oral PrEP discontinuation within a nationwide PrEP users' cohort. |
| PrEP adherence | through study completion, an average of 5 years | Self-reported oral PrEP adherence. |
| Time to discontinuation | through study completion, an average of 5 years | Time elapsed between oral PrEP initiation and oral PrEP discontinuation. |
| HIV incident infection | through study completion, an average of 5 years | Incidence of HIV seroconversions |
| PrEP discontinuation | through study completion, an average of 5 years | Prevalence of oral PrEP discontinuation within a nationwide PrEP users' cohort. |
Countries
Spain
Contacts
Primary ContactAnaïs Corma-Gómez
Outcome results
None listed