Skip to main content
OpenTrials
Completed

NCT Number: NCT06563284

HealthcAre sUppoRt fOr Remote HIV pAtients

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AURORA Mobile App

Other

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.

Primary outcomes

  1. Effective use of the mobile application

    Time frame: 6 months

    Frequency of interaction with the mobile application

Secondary outcomes

  1. Adherence to therapy

    Time frame: Everyday, through study completion (6 months)

    Frequency of click in the mobile application

  2. EuroQol five-dimensional questionnaire

    Time frame: Twice, at baseline and after 4 months

    Quality of life assessment questionnaire

  3. Pittsburgh Sleep Quality index

    Time frame: Twice, at baseline and after 4 months

    Quality of sleep assessment questionnaire

  4. Generalized Anxiety Disorder 7

    Time frame: Twice, at baseline and after 4 months

    Questionnaire for assessment of generalized anxiety state

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

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

Acronym: AURORA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.