Observing tenofovir PrEP use in men at high risk for HIV in Seville
Follows adult men at high risk of HIV who take tenofovir to prevent infection.
Plain-language title generated from the registry record
Registry title: Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis
Key facts
- Where
- Seville, SpainSee the site
Where in Spain
- Virgen del Rocio University HospitalSeville, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospitales Universitarios Virgen del Rocío
- Trial code
- NCT05492565
- Record updated
- 22 September 2023
- Original description
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).Read full original descriptionShow less
A Study to Evaluate Clinical Benefits and Drawbacks of Antiretroviral Drugs as Pre-exposure Prophylaxis to Prevent HIV Infection Under Real-life Conditions Among Persons Who Pursue High-risk Sexual Practices: The Seville HIV PrEP Cohort
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.
Inclusion: 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.
Exclusion: For on-demand PrEP: diagnosis of chronic hepatitis B; Allergic to TDF and/or FTC; Glomerular filtration rate <60 ml/min.