HIV InfectionsAURORANCT06563284
HealthcAre sUppoRt fOr Remote HIV pAtients
An observational study of HIV Infections, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- AURORA Mobile App
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2022to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected patients in virological suppression who have been treated with a stable antiretroviral regimen for at least six months
Who may be able to join
- 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
Who cannot join
- Newly diagnosed patients
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- HIV Infections
- Being tested
- AURORA Mobile App
- Keywords
- HIV/AIDS, Mobile application, Digital Health
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AURORA Mobile AppOther
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 | Role | What they receive |
|---|---|---|
| Study Group | HIV-infected patients in virological suppression who have been treated with a stable antiretroviral regimen for at least six months Receives: Other: AURORA Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective use of the mobile application
Frequency of interaction with the mobile application
Measured: 6 months
Secondary outcomes (4)
Adherence to therapy
Frequency of click in the mobile application
Measured: Everyday, through study completion (6 months)
EuroQol five-dimensional questionnaire
Quality of life assessment questionnaire
Measured: Twice, at baseline and after 4 months
Pittsburgh Sleep Quality index
Quality of sleep assessment questionnaire
Measured: Twice, at baseline and after 4 months
Generalized Anxiety Disorder 7
Questionnaire for assessment of generalized anxiety state
Measured: Twice, at baseline and after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start20 Dec 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563284
- Sponsor's protocol ID
- ASO.MInf.22.07
- Acronym
- AURORA
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06563284
- Acronym / sponsor ID
- AURORA / ASO.MInf.22.07
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, Mobile application, Digital Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: AURORA Mobile AppHIV-infected patients in virological suppression who have been treated with a stable antiretroviral regimen for at least six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients in virological suppression who have been treated with a stable antiretroviral regimen for at least six months
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Newly diagnosed patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AURORA Mobile AppEnrolled 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. | Other | Study Group |
Primary outcome
Effective use of the mobile application
Time frame: 6 months
Frequency of interaction with the mobile application
4 secondary outcomes
Adherence to therapy
Time frame: Everyday, through study completion (6 months)
EuroQol five-dimensional questionnaire
Time frame: Twice, at baseline and after 4 months
Pittsburgh Sleep Quality index
Time frame: Twice, at baseline and after 4 months
Generalized Anxiety Disorder 7
Time frame: Twice, at baseline and after 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective use of the mobile application (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.