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

NCT06528626 | Recruiting

• 1 other identifier: PI22/01878
• Study Type: interventional
• Target: 240,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV/AIDS; STD; HCV

Outcome Measures

Primary Outcomes (1)

• 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

  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

  3 years

Study Arms (3)

Observational

NO INTERVENTION

self-questionnaire SQ-R&IC

ACTIVE COMPARATOR

Diagnostic Test: rapid HIV and HCV serological tests

rapid HIV and HCV serological tests

ACTIVE COMPARATOR

Diagnostic Test: rapid HIV and HCV serological tests

Interventions

rapid HIV and HCV serological tests DIAGNOSTIC_TEST

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.

Also known as: self-questionnaire SQ-R&IC

rapid HIV and HCV serological tests; self-questionnaire SQ-R&IC

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• European Union: collaborator

Study Sites (1)

Maria J. Vivancos-Gallego

Madrid, Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Maria J. Vivancos-Gallego, MD, PhD

CONTACT

+34913368672; mariajesus.vivancos@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 30, 2024
• Study Start: July 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)