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NCT Number: NCT06528626

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

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

Recruiting

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Key information

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria J. Vivancos-Gallego

Madrid, 28034, Spain

Location status: Recruiting

Location contact

Maria J. Vivancos Gallego, MD, PhD

CONTACT

[email protected]

+34913368672

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: self-questionnaire SQ-R&IC

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

    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 contacts

Contact information is provided by the study sponsor or research team.

Maria J. Vivancos-Gallego, MD, PhD

CONTACT

[email protected]

+34913368672

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)
  • European Union

Registry information

Official study title

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

Acronym: ATENEA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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