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

NCT ID: NCT06528626

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV/AIDS STD HCV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Observational

Group Type NO_INTERVENTION

No interventions assigned to this group

self-questionnaire SQ-R&IC

Group Type ACTIVE_COMPARATOR

rapid HIV and HCV serological tests

Intervention Type 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.

rapid HIV and HCV serological tests

Group Type ACTIVE_COMPARATOR

rapid HIV and HCV serological tests

Intervention Type 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.

Interventions

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rapid HIV and HCV serological tests

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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self-questionnaire SQ-R&IC

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role collaborator

European Union

OTHER

Sponsor Role collaborator

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maria J. Vivancos-Gallego

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maria J. Vivancos-Gallego, MD, PhD

Role: CONTACT

+34913368672

Facility Contacts

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Maria J. Vivancos Gallego, MD, PhD

Role: primary

+34913368672

Other Identifiers

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PI22/01878

Identifier Type: -

Identifier Source: org_study_id

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