HealthcAre sUppoRt fOr Remote HIV pAtients (AURORA)

HealthcAre sUppoRt fOr Remote HIV pAtients: Use of an App to Support HIV+ Patients to Ensure Continuity of Care and Assess Its Impact on Therapy Adherence and Quality of Life

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

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: AURORA Mobile App

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • SC Malattie Infettive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients in virological suppression who have been treated with a stable antiretroviral regimen for at least six months

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; HIV-infected patients in virological suppression who have been treated with a stable antiretroviral regimen for at least six months	Other: AURORA Mobile App; Enrolled subjects will be asked to download the app for free from their smartphone store. Weekly/bi-weekly updates were collected, and therapy adherence was facilitated with timed alerts. Patients completed the EQ-5D-5L, PSQI, PHQ-9 and GAD-7 questionnaires every four months to track quality of life, sleep quality, depression and anxiety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective use of the mobile application	Frequency of interaction with the mobile application	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Digital Health; HIV/AIDS; Mobile application
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: ASO.MInf.22.07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No