Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis (NCT05492565) | Clinical Trial Compass
By InvitationNot Applicable
Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis
Spain500 participantsStarted 2020-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Glomerular filtration rate \<60 ml/min.
* For on-demand PrEP: diagnosis of chronic hepatitis B.
* Allergic to TDF and/or FTC.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline proportion of PrEP users with STI-4c at one year
Timeframe: Baseline through one year
2
Incidence of primary HIV infection
Timeframe: Through study completion (an average 3 years)