Wedge-Shaped Clustered Randomized Trial to Evaluate Two Tools to Identify People At Risk or Already Infected with HIV and HCV

What this Trial Is About

This research aims to reduce hidden and new infections of HIV and HCV by evaluating two tools designed for risk identification and screening. The study uses a stepped-wedge cluster randomized design across eight community health centers in Madrid. It compares the effectiveness of a self-questionnaire and rapid serological tests against the standard care approach in identifying people at risk or already infected with HIV and HCV. Participants receive standard care where health personnel ask questions to assess HIV risk and use electronic alerts for HIV indicator conditions, along with laboratory serological tests for HIV and HCV. In the intervention group, in addition to standard care, participants can access a self-questionnaire via a QR code and rapid HIV and HCV tests. The study compares testing rates, referrals for pre-exposure prophylaxis (PrEP), and new diagnoses between groups. During the study, participants complete questionnaires and undergo HIV and HCV testing. Researchers monitor the implementation of the self-questionnaire and rapid tests over three years. They track the number of tests performed, referrals made, and new infections diagnosed. The study involves participants aged 14 to 65 years and includes follow-up to evaluate the tools' impact on improving screening and linkage to care.

Tools to Identify People At Risk or Already Infected with HIV and HCV