NCT05492565Enrolling by invitation
Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 30 Jul 2022
- Start date
- 1 Jan 2020
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Diseases
- HIV
- NCT number
- NCT05492565
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Jan 2020 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- For on-demand PrEP: diagnosis of chronic hepatitis B.
- Allergic to TDF and/or FTC.
Other
- Glomerular filtration rate \<60 ml/min.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virgen del Rocio University Hospital Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.