Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis

NCT05492565 | Enrolling By Invitation FDA Drug

• 2 other identifiers: SeVIHPrEP CohortFIS-PRE-2022-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Pre-exposure prophylaxis (PrEP) based on tenofovir represents a considerably new preventive intervention that has shown to significantly decrease the number of HIV infections while it enables early diagnosis of HIV and other sexually transmitted diseases (STI). In Southern Spain, the target population to receive PrEP are men who have sex with men (MSM) with a history of STI and who pursue high-risk sexual practices regarding the acquisition of HIV, including an elevate number of sex partners, no or inconsistent condom use and the use of specific recreational drugs in the context of sexual activity ("chemsex"). Despite the benefits of PrEP use, it must be taken into consideration that risk compensations that may facilitate the acquisition of other STI may occur, including a higher implementation of risk practices and an increase in the number of partners, which is made easy as various social networks designed for this purpose are available nowadays. In order to better understand the benefit/drawback ratio, accurate data of a population using PrEP under real-life conditions, with densely scheduled follow-up and well-characterized (socio-)demographic parameters, sexual behaviour and STI are warranted.

Conditions

HIV Infection Primary; Hepatitis, Viral, Human; Sexually Transmitted Infections, Excluding HIV and Hepatitis

Keywords

PrEP; tenofovir disoproxyl fumarate; emtricitabine; HIV; Treponema pallidum; Neisseria gonorrhoeae; Chlamydia trachomatis; Mycoplasma genitalium; human papillomavirus; men who have sex with men; ChemSex

Outcome Measures

Primary Outcomes (2)

• Change from baseline proportion of PrEP users with STI-4c at one year

  Analysis of a change in the proportion of persons that present with infection by at least one of the following four common sexually transmitted pathogens (STI-4c): Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis and/or Mycoplasma genitalium.

  Baseline through one year

• Incidence of primary HIV infection

  Determination of the incidence of primary HIV infections during PrEP use

  Through study completion (an average 3 years)

Secondary Outcomes (8)

• Proportion of PrEP users with STI other than STI-4c or HIV

  Through study completion (an average 3 years)

• Number of STI

  Through study completion (an average 3 years)

• Incidences of STI other than HIV

  Through study completion (an average 3 years)

• Sexual behaviour

  Through study completion (an average 3 years)

• Adverse events

  Through study completion (an average 3 years)

Study Arms (4)

Men who have sex with men

Men who have sex with men at substantial risk for HIV infection due to high-risk sexual habits

Drug: Tenofovir Disoproxil Fumarate 300 MG Oral Tablet

Transgender women

Transgender women at substantial risk for HIV infection due to high-risk sexual habits

Drug: Tenofovir Disoproxil Fumarate 300 MG Oral Tablet

Sex workers

Sex workers at substantial risk for HIV infection due to high-risk sexual habits

Drug: Tenofovir Disoproxil Fumarate 300 MG Oral Tablet

HIV-uninfected people at substantial risk for HIV infection (other)

All HIV-uninfected people at substantial risk for HIV infection due to any other reason, including having an HIV-positive life partnerwith an HIV-positive life partner

Drug: Tenofovir Disoproxil Fumarate 300 MG Oral Tablet

Interventions

Tenofovir Disoproxil Fumarate 300 MG Oral Tablet DRUG

Pre-exposure prophylaxis with coformulated Tenofovir Disoproxil Fumarate 300mg/Emtricitabine 200mg oral QD to prevent HIV infection

Also known as: Emtricitabine 200 MG Oral Tablet

HIV-uninfected people at substantial risk for HIV infection (other); Men who have sex with men; Sex workers; Transgender women

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The participants of the SeVIHPrEP cohort are recruited from the candidates for a PrEP programme derived from the outpatient STI clinic at the Clinical Unit of Infecious Diseases and Preventive Medicine (Unidad Clínica de Enfermedades Infecciosas y Medicina Preventiva, UCEIMP) of the Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío) in Seville, Spain. Candidates are informed about the SeVIHPrEP protocol, an information sheet is handed out and additionally, the study is explained by the physician. They are then invited to participate in the cohort and upon acceptance, are asked to sign a written informed consent.

You may qualify if:

• HIV negative as demonstrated by negative HIV serology as determined by EIA and Western-Blot.
• Older than 18 years.
• At high risk of acquiring HIV infection by sexual transmission.
• MSM and transsexual persons who met at least two of the following criteria during the year prior to visit:
• More than ten different sexual partners.
• Anal sexual intercourse without using a condom.
• Consumption of drugs in order to establish and/or maintain sexual relations without condom.
• Administration of post-exposition prophylaxis in various occasions de profilaxis post- exposición en varias ocasiones.
• At least one bacterial STI.
• Women who prostitute themselves with no or irregular use of a condom. -Start daily or on-demand PrEP with TDF/FTC.
• Give their written informed consent to participate in the cohort and its substudies.

You may not qualify if:

• Glomerular filtration rate \<60 ml/min.
• For on-demand PrEP: diagnosis of chronic hepatitis B.
• Allergic to TDF and/or FTC.

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead
• Instituto de Biomedicina de Sevilla: collaborator

Study Sites (1)

Virgen del Rocío University Hospital

Seville, Andalusia, 41013, Spain

Location

Related Publications (19)

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Related Links

• United Nations Programme on HIV/AIDS 2020. 90-90-90: An ambitious treatment target to help end the AIDS epidemic. 2019
• Ministerio de Sanidad Servicios Sociales e Igualdad. Documento de consenso. Profilaxis Preexposición al VIH en España. Plan Nacional sobre el Sida. Published Online First: 2018

Biospecimen

Retention: SAMPLES WITH DNA

anal-rectal, oral and/or urethral exudate

MeSH Terms

Conditions

Hepatitis, Viral, Human; Sexually Transmitted Diseases; Hepatitis; Treponemal Infections; Homosexuality; Chemsex

Interventions

Tenofovir; Tablets; Emtricitabine

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Liver Diseases; Digestive System Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Karin Neukam, PharmD, PhD

  Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla

  STUDY DIRECTOR

• César Sotomayor de la Piedra, MD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

• Marta Herrero Romero, MD, PhD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

• Alicia Gutiérrez Valencia, PharmD, PhD

  Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla

  PRINCIPAL INVESTIGATOR

• Luis F López-Cortés, MD, PhD

  Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 8, 2022
• Study Start: January 1, 2020
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

ES (1)