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

Launched by HOSPITALES UNIVERSITARIOS VIRGEN DEL ROCÍO · Aug 5, 2022

Keywords

ClinConnect Summary

This study, called SeVIHPrEP, is a real-life look at using HIV pre-exposure prophylaxis (PrEP) in Seville, Spain. It follows about 500 HIV-negative adults at substantial risk of HIV for roughly 3 years to see how well PrEP (a combination pill of tenofovir disoproxil fumarate and emtricitabine) works in everyday life, how often other sexually transmitted infections (STIs) occur, and how safe and how adherent people are to the medication. Participants are followed regularly to test for HIV and STIs, monitor for side effects, and collect information about sexual behavior and how well they stick to the pill schedule.

Who can participate? Adults 18 and older who are HIV-negative and at high risk of HIV infection—such as men who have sex with men, transgender women, sex workers, or others with high-risk sexual activity—are eligible if they meet at least two of several risk criteria in the past year (for example, more than 10 sexual partners or unprotected sex). People with significantly reduced kidney function or, for on-demand PrEP, chronic hepatitis B, may not be eligible for certain PrEP approaches. Participants will receive PrEP pills to take either daily or around sexual activity, with visits over the study period to check HIV status, screen for STIs, assess safety, and learn about their experiences with PrEP. The trial is ongoing, and results are not yet available.

Gender

ALL

Eligibility criteria

• 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.