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

HIV Infections Clinical Trial

— INTERFACE 3436  

Official title:

INTERFACE: hIv patieNts TracER For clinicAl assistanCe and rEsearch During COVID 19 Epidemic: a Paradigm for Chronic Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711680
• Other study ID #: 3436
• Status: Recruiting
• Start date: January 18, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Italy	ASST degli Ospedali Civili di Brescia	Brescia	BS
Italy	3. Azienda Ospedaliera Universitaria Policlinico "San Martino" IRCCS di Genova	Genova	GE
Italy	Fondazione PoliclinicoAgostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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