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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Enrolling

Conditions: STD; HCV; HIV/AIDS

Treatments: Diagnostic Test: rapid HIV and HCV serological tests

Study type: Interventional

Funder types: Other

Identifiers

NCT06528626

PI22/01878

Details and patient eligibility

About

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

Full 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.

Enrollment: 240,000 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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240,000 participants in 3 patient groups

Observational

No Intervention group

self-questionnaire SQ-R&IC

Active Comparator group

Treatment:

Diagnostic Test: rapid HIV and HCV serological tests

rapid HIV and HCV serological tests

Active Comparator group

Treatment:

Diagnostic Test: rapid HIV and HCV serological tests