HealthcAre sUppoRt fOr Remote HIV pAtients

NCT06563284 | Completed

• 1 other identifier: ASO.MInf.22.07
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infections

Keywords

HIV/AIDS; Mobile application; Digital Health

Outcome Measures

Primary Outcomes (1)

• Effective use of the mobile application

  Frequency of interaction with the mobile application

  6 months

Secondary Outcomes (4)

• Adherence to therapy

  Everyday, through study completion (6 months)

• EuroQol five-dimensional questionnaire

  Twice, at baseline and after 4 months

• Pittsburgh Sleep Quality index

  Twice, at baseline and after 4 months

• Generalized Anxiety Disorder 7

  Twice, at baseline and after 4 months

Study Arms (1)

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

Interventions

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.

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Newly diagnosed patients

Sponsors & Collaborators

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

Study Sites (1)

SC Malattie Infettive

Alessandria, Piedmont, 15121, Italy

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 20, 2024
• Study Start: December 20, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

IT (1)