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

Not Applicable

Recruiting

• Conditions: STD; HCV; HIV/AIDS
• Interventions: Diagnostic Test: rapid HIV and HCV serological tests

• Registration Number: NCT06528626
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary

Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to identify People at Risk or already Infected with HIV and HCV

Detailed Description

Objectives: To reduce hidden and incident HIV and HCV infection, through the implementation of a risk and indicator conditions self-questionnaire SQ-R\&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests (RT), in the Health Centers (HC). Methodology: stepped-wedge cluster randomized trial in 8 CS of the community of Madrid, to to know if the implementation of the 2 tools described above, improve risk identification and subsequent screening for HIV and HCV infection. In the standard of care branch (SOC), the health personnel will ask people a series of questions to identify the HIV risk exposition, and also they will be provided pop-up computer alerts of HIV indicator conditions in the electronic medical record, moreover HIV and HCV serological tests will be carried out in the reference laboratory, while in the intervention branch in addition to the SOC, a SQ-R\&IC of HIV and HCV will be made available to the HC population, through a quick response (QR) code, as well as HIV and HCV RT. The variables that will be compared are the percentage of HIV and HCV tests performed, of people referred to receive PrEP, and of new HIV and HCV diagnoses or not linked to care that are made during the periods assigned to the EDC branch vs. those in the intervention branch.

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-07-05
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-07-30
• Primary Completion: 2025-01-01
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240000

Inclusion Criteria

• 14-65 years in the health area or who are captured for inclusion by health personnel. They give their consent to participate.

Exclusion Criteria

• Having already been included in the study, not signing the consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
rapid HIV and HCV serological tests	rapid HIV and HCV serological tests	-
self-questionnaire SQ-R&IC	rapid HIV and HCV serological tests	-

Primary Outcome Measures

Name	Time	Method
Implementation of a risk and indicator conditions self-questionnaire SQ-R&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests	3 years	Number of Participants With the implementation of a risk and indicator conditions self-questionnaire SQ-R\&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests, Change From Baseline in hidden and incident HIV and HCV infection at 3 Years

Trial Locations

Locations (1)

Maria J. Vivancos-Gallego; 🇪🇸 Madrid, Spain