HealthcAre sUppoRt fOr Remote HIV pAtients

Completed

• Conditions: HIV Infections
• Interventions: Other: AURORA Mobile App

• Registration Number: NCT06563284
• Lead Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Brief Summary

Adherence to antiretroviral therapy (ART) is crucial for treatment success in HIV+ patients. This study proposes the use of a smartphone application, specifically developed for this project, to monitor ART adherence and assess quality of life among HIV+ patients. The aim is to optimize long-term disease management through the early identification of comorbidities and clinical complications

Detailed Description

Since the first cases were reported more than 35 years ago, 78 million people have been infected with HIV and 35 million have died from AIDS-related illnesses.

Currently, the availability of TARV regimens associated with good tolerability and high levels of efficacy make it necessary to turn attention toward new standards of efficacy indicative of patients' mental and physical well-being. Indeed, health-related quality of life (HRQoL) is becoming increasingly preponderant as a therapeutic outcome. Despite TARV-related viroimmunologic success, people living with HIV (PLWH) continue to have lower HRQoL than the general population. Indeed, much evidence confirms the impact on quality of life not only of therapeutic treatments but also of social and relationship issues and comorbidities. Improving HRQoL is now, therefore, a primary goal for the care and support of PLWH.

Evaluations of new treatments and interventions to improve care, therefore, require the measurement, in addition to clinical endpoints, of HRQoL using valid and reliable instruments. Therefore, the importance of PROs (Patient Reported Outcomes), which represent the description of the patient's own reported state of health, without any interpretation by clinicians or health care personnel, emerges in this area. In this way, the patient is directly involved in his or her own process of care.

Adherence to TARV is essential for successful treatment and improved quality of life. Unfortunately, non-adherence to treatment is a common problem among HIV-infected patients.

The Covid-19 emergence has significantly revolutionized the health care system leading to the implementation of new modes of care, including the use of technological tools to ensure remote medical care.

The present study, targeting HIV-infected patients undergoing virological suppression, aims to use a smartphone application to facilitate continuity of care remotely, promoting adherence to therapy and thus the effectiveness of TARV, assessing the patient's quality of life and identifying possible comorbidities or other critical clinical

Study Timeline

• Study Start: 2022-12-20
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ≥ 18 years
• HIV-infected patients
• HIV plasma RNA values < 50 copies/mL
• Patients referred to the HIV outpatient clinic at the SC Infectious Diseases of the Azienda Alexandria Hospital
• Patients on a stable antiretroviral regimen for at least 6 months
• Patients who have the ability to download the application under study
• Patients who have signed the informed consent

Exclusion Criteria

• Newly diagnosed patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	AURORA Mobile App	HIV-infected patients in virological suppression who have been treated with a stable antiretroviral regimen for at least six months

Primary Outcome Measures

Name	Time	Method
Effective use of the mobile application	6 months	Frequency of interaction with the mobile application

Secondary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder 7	Twice, at baseline and after 4 months	Questionnaire for assessment of generalized anxiety state
Pittsburgh Sleep Quality index	Twice, at baseline and after 4 months	Quality of sleep assessment questionnaire
Adherence to therapy	Everyday, through study completion (6 months)	Frequency of click in the mobile application
EuroQol five-dimensional questionnaire	Twice, at baseline and after 4 months	Quality of life assessment questionnaire

Trial Locations

Locations (1)

SC Malattie Infettive; 🇮🇹 Alessandria, Piedmont, Italy