INTERFACE: hIv patieNts TracER For clinicAl assistanCe and rEsearch During COVID 19

NCT ID: NCT05711680

Last Updated: 2023-02-08

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

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-18

Study Completion Date

2024-12-30

Brief Summary

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The health emergency related to the SARS CoV2 pandemic has highlighted the problems of health management of patients at risk of COVID19 and with chronic diseases, suggesting the need for new methods of patient monitoring. Teleconsultation, and telemedicine in general, are applications that allow, at these times when access to hospitals is by definition limited, to monitor patients with chronic conditions who need regular and consistent care and monitoring. People living with HIV/AIDS (PLWHA) represent a paradigm of chronic patients on whom the development of e-health-based remote monitoring could have a significant impact in terms of maintaining an adequate standard of care. For these reasons, in a large teaching hospital we are planning the creation and use of an application to enable remote monitoring of PLWHA by combining the COVID19 prescreening system and chronicity monitoring.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Device

To develop an e-health system to remotely monitor patients with chronic HIV infection and conduct early screening for COVID-19 through a telemonitoring, teleconsultation and periodic remote visit system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age of patients\>18 years. Patients able to use apps and smart devices without caregivers or, if the patient is unable to use them, patients with caregivers able to use apps and smart devices.
* Able to provide informed consent

Exclusion Criteria

* Patients unable to use smart devices and apps without the presence of caregivers - Recent diagnosis of HIV infection (\<3 months)
* Any unstable clinical condition requiring hospitalization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ASST degli Ospedali Civili di Brescia

Brescia, BS, Italy

Site Status NOT_YET_RECRUITING

3. Azienda Ospedaliera Universitaria Policlinico "San Martino" IRCCS di Genova

Genova, GE, Italy

Site Status NOT_YET_RECRUITING

Fondazione PoliclinicoAgostino Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Eugenia Quiros Roldan

Role: primary

0303996618

Antonio Di BIagio

Role: primary

0105551

Antonella Cingolani

Role: primary

00390630154945

Other Identifiers

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3436

Identifier Type: -

Identifier Source: org_study_id

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