Sexually Transmitted Infections (STIs)STI_PrEPareNCT06860945

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

An observational study of Sexually Transmitted Infections (STIs) and HIV, run by Hospital Universitario de Valme at 26 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for: Sexually Transmitted Infections (STIs), HIV, PrEP
Type of treatment: Pill or oral medicine
How many people: 9,000 participants
Where: 26 sitesSpain
Study dates: 1 Jan 2025to 1 Jan 2026
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: All individuals who meet the criteria for PrEP use in Spain, are over 16 years old, and have taken at least one pill.

Who may be able to join

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

Who cannot join

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anaïs Corma-Gómez contact

+34676170692

anais.corgo@gmail.com

City, postcode or hospital

Sites recruiting now only

26 sites in 1 country

Spain26 sites, 26 recruiting

Hospital Universitario de Torrecárdenas
Almería
Bárbara Hernández, MD, +34674664770, b.hernandezsierra@hotmail.com
Bárbara Hernández
Recruiting
Hospital Universitario Puerto Real
Cadiz
Alberto Romero, MD, PhD, +34657748972, albertoromeropalacios@gmail.com
Alberto Romero, MD, PhD
Recruiting
Hospital Universitario Santa Lucía
Cartagena
Francisco J Vera, +34620691802, franciscovera72@gmail.com
Francisco J Vera, MD, PhD
Recruiting
hospital Universitario reina Sofía
Córdoba
Diana Corona-Mata, MD, PHD, +34619229336, d.corona.mata@gmail.com
Diana Corona-mata, MD, PhD
Recruiting
Hospital Virgen de la Luz
Cuenca
Olga Belinchón, +34969 17 99 00, olgabelinchon@yahoo.es
Olga Belinchón
Recruiting
Hospital Universitario de Elche
Elche
Javier García, MD, +3496 6616754, javiergarciaabellan@hotmail.com
Javier García
Recruiting
Hospital Clínico Universitario San Cecilio
Granada
Naya Faro, MD, +34607940022, naya.faro@gmail.com
Naya Faro
Recruiting
Hospital Universitario Virgen de las Nieves
Granada
+34627010441, chidalgo72@gmail.com
Carmen Hidalgo
Recruiting
Hospital Universitario Juan Ramón Jiménez
Huelva
Miguel Raffo, MD, +34670018065, xhalveyxx@hotmail.com
Miguel Raffo
Recruiting
Complejo Hospitalario de Jaén
Jaén
Carmen Herrero, MD, +34600511475, gonees.data@hotmail.es
Carmen Herrero, MD
Recruiting
Hospital de Jerez de la Frontera
Jerez de la Frontera
Salvador López, MD, PhD, +34605353318, salvador_lopez_cardenas@jerez.es
Salvador López, MD, PhD
Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat
Jaime Vega, MD, +3493 260 75 00, jvega@bellvitgehospital.cat
Jaime Vega
Recruiting
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria
Karim Mohammed, MD, +34928 45 00 00, karimmohamedramirez@gmail.com
Karim Mohammed
Recruiting
Centro Sanitario Sandoval
Madrid
Eva Orviz, MD, +34699205999, evaorviz@gmail.com
Eva Orviz
Recruiting
Hospital Fundación Jiménez Díaz
Madrid
Alfonso Cabello, +346511539707, ACabello@fjd.es
Alfonso Cabello
Recruiting
Hospital Universitario Infanta Leonor
Madrid
Jorge Valencia, MD, PhD, +34661671082, jorge_vlr@yahoo.es
Jorge Valencia
Recruiting
Hospital Universitario La Princesa
Madrid
Lucio García-Fraile, MD, +34656943726, lucio.garciafraile@gmail.com
Lucio García-Fraile, MD
Recruiting
Hospital Regional Universitario de Málaga
Málaga
Inés Pérez Camacho, MD, PhD, +34667531564, inpercam@gmail.com
Inés Pérez-Camacho
Recruiting
Hospital Universitario Virgen de la Victoria
Málaga
Cristina Gómez, MD, PhD, 0034 686873786, cgayerbe@gmail.com
Cristina Gómez-Ayerbe, MD, PhD
Recruiting
Hospital Universitario Virgen de la Arrixaca
Murcia
Antonia Castillo, MD, +34650010933, amcastillonavarro@gmail.com
Antonia Castillo
Recruiting
Hospital Universitario Marqués de Valdecilla
Santander
Francisco Arnaiz, +34942 20 25 20, francisco.arnaizlasrevillas@scsalud.es
Francisco Arnaiz
Recruiting
Hospital Universitario Virgen de la Macarena
Seville
Jesús Sojo, +34600375968, jesodo@hotmail.com
Jesús Sojo, MD
Recruiting
Hospital Universitario Virgen de Valme
Seville
Juan Macías, MD, PhD, +34955015757, jmacias7@us.es
Juan Macías, MD, PhD
Recruiting
Hospital Universitario Virgen del Rocío
Seville
Cesar Sotomayor, MD, +34658329709, caesarsotomayor@yahoo.com
Cesar Sotomayor
Recruiting
Hospital Universitario de Valladolid
Valladolid
Pablo Tellería, +34983 420 000, pablotelleria92@gmail.com
Pablo Tellería
Recruiting
Hospital Universitario Álvaro Cunqueiro
Vigo
Luis E Morano, MD, PhD, +34654028646, luis.morano.amado@gmail.com
Luis E Morano, MD, PhD
Recruiting

Other trials in Spain

About this study

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.

Conditions: Sexually Transmitted Infections (STIs), HIV, PrEP
Being tested: No Intervention: Observational Cohort
Keywords: STI, HIV, PrEP, modelling, machine learning, adherence, persistence
Medical subject headings: Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No Intervention: Observational CohortOther
No Intervention: Observational Cohort

Study groups in NCT06860945
Study group	Role	What they receive
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: * 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. Receives: Other: No Intervention: Observational Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

STI predictive model
Predictive model for the acquisition of sexually transmitted infections in individuals using PrEP within the national provision program for this strategy
Measured: through study completion, an average of 5 years

Secondary outcomes (11)

STI incidence
Incidence of sexually transmitted infections (STIs) in the cohort globally and by type of infection.
Measured: 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
Measured: through study completion, an average of 5 years
asymptomatic STIs
Proportion of asymptomatic STIs diagnosed within the screening program.
Measured: through study completion, an average of 5 years
behavioral changes
Sexual risk behaviors of individuals in the cohort, before and after initiating PrEP
Measured: 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)
Measured: through study completion, an average of 5 years
PrEP discontinuation
Prevalence of oral PrEP discontinuation within a nationwide PrEP users' cohort.
Measured: through study completion, an average of 5 years
Predictor of PrEP discontinuation
Predictors of oral PrEP discontinuation within a nationwide PrEP users' cohort.
Measured: through study completion, an average of 5 years
PrEP adherence
Self-reported oral PrEP adherence.
Measured: through study completion, an average of 5 years
Time to discontinuation
Time elapsed between oral PrEP initiation and oral PrEP discontinuation.
Measured: through study completion, an average of 5 years
HIV incident infection
Incidence of HIV seroconversions
Measured: through study completion, an average of 5 years
HIV incident infection
Profiles of those who acquire HIV while taking oral PrEP.
Measured: through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20251 Jan 2026

First posted6 Mar 2025
Study start1 Jan 2025
Primary completion30 Jun 2025 (estimated)
Study completion1 Jan 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Sexually Transmitted Infections (STIs)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 9,000 participants (estimated)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06860945
Sponsor's protocol ID: STI_PrEP24
Acronym: STI_PrEPare
Status last verified: Feb 2025
First submitted: 18 Feb 2025
Last updated: 6 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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. Sex Transm Infect. 2023 May;99(3):149-155. doi: 10.1136/sextrans-2022-055439. Epub 2022 May 18.
PubMed 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.
PubMed 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.
PubMed 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/jamanetworkopen.2020.30806.
PubMed 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.
PubMed 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-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.
PubMed 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 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.
PubMed 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 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.
PubMed 30964528
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.
PubMed 31178284
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.
PubMed 34310371
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.
PubMed 22784037
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.
PubMed 25065857
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.
PubMed 21091279

Interested in taking part?

Anaïs Corma-Gómez

+34676170692

anais.corgo@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Sexually Transmitted Infections (STIs) trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
ClinicalTrials.gov ID: NCT06860945
Acronym / sponsor ID: STI_PrEPare / STI_PrEP24
Conditions: Sexually Transmitted Infections (STIs), HIV, PrEP
Keywords: STI, HIV, PrEP, modelling, machine learning, adherence, persistence
Study type: Observational
Recruitment status: Recruiting
Enrolment: 9,000 participants (estimated)
Lead sponsor: Hospital Universitario de ValmeUniversity, hospital or other
Collaborators: Instituto de Salud Carlos III
Study start: 1 Jan 2025 (actual)
Primary completion: 30 Jun 2025 (estimated)
Study completion: 1 Jan 2026 (estimated)
First posted: 6 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 5 Years
Number of arms: 1

Arm	Type	Receives
STI_PrEPare	–	Other: No Intervention: Observational CohortAll 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: * 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: All individuals who meet the criteria for PrEP use in Spain, are over 16 years old, and have taken at least one pill.

Key inclusion criteria (8 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No Intervention: Observational CohortNo Intervention: Observational Cohort	Other	STI_PrEPare

Primary outcome

STI predictive model
Time frame: 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

11 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Background: PubMed 35584898Jongen 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.
Background: PubMed 32205724Tang 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.
Background: PubMed 33431605van 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.
Background: PubMed 33355675McManus 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.
Background: PubMed 29509889Traeger 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.
Background: PubMed 38492988Ayerdi 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.
Background: PubMed 35643090Traeger 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.
Background: PubMed 30964528Traeger 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.
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Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Anaïs Corma-Gómez contact

+34676170692

anais.corgo@gmail.com

Anaïs Corma-Gómez, MD, PhD principal investigator

Hospital Clínico Universitario de Valencia

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sexually Transmitted Infections (STIs) and HIV, run by Hospital Universitario de Valme at 26 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anaïs Corma-Gómez (+34676170692, anais.corgo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

STI predictive model (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06860945, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.