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Clinical Trials/NCT06528626
NCT06528626
Recruiting
Not Applicable

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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal1 site in 1 country240,000 target enrollmentJuly 1, 2023
ConditionsHIV/AIDSSTDHCV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Enrollment
240000
Locations
1
Primary Endpoint
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
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
December 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 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

Study Sites (1)

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