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

NCT05711680 | Unknown

• 1 other identifier: 3436
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• A new model for patient follow-up

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

  1 year

Interventions

Device 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All PLWHA on antiretroviral therapy will be enrolled in this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (3)

ASST degli Ospedali Civili di Brescia

Brescia, BS, Italy

NOT YET RECRUITING

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

Genova, GE, 16132, Italy

NOT YET RECRUITING

Fondazione PoliclinicoAgostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 3, 2023
• Study Start: January 18, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)