Clinical trial NCT06563284: HealthcAre sUppoRt fOr Remote HIV pAtients
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV/AIDS
Mobile application
Digital Health
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Effective use of the mobile application
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to therapy
timeFrame: Everyday, through study completion (6 months)
measure: EuroQol five-dimensional questionnaire
timeFrame: Twice, at baseline and after 4 months
measure: Pittsburgh Sleep Quality index
timeFrame: Twice, at baseline and after 4 months
measure: Generalized Anxiety Disorder 7
timeFrame: Twice, at baseline and after 4 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: SC Malattie Infettive
state: Piedmont
Study officials:
References: