- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07571044
Project to Enhance Patient-Health Engagement in HIV Infection (HIV-IN-ACTION)
Project to Enhance Patient-Health Engagement in HIV Infection: Optimizing Quality of Life and Psychological Well-being Through Involvement (HIV-IN-ACTION)
The importance of patient involvement in their care is emerging as a crucial element in the active management of chronic conditions, including HIV infection. For people living with HIV (PLWH), a proactive role in managing their health promotes improved quality of life and greater adherence to treatment. However, data on enhancing patient engagement among PLWH are currently lacking.
This project aims to offer, for the first time, training to enhance patient engagement specifically for PLWH, delivered by psychologists at the Infectious Diseases Outpatient Clinic of the Gemelli Hospital in Rome. The program aims to strengthen emotional, cognitive, and behavioral involvement in the treatment process, promoting greater adherence to treatment, improved management of comorbidities, and increased healthy behaviors. Furthermore, the project aims to adapt the training to the specific needs of PLWH and evaluate its actual impact on quality of life and psychological well-being.
Scientific Rationale Over 38 million people are living with HIV worldwide, with approximately 1.5 million new infections in 2021. In Italy, 1,770 new HIV diagnoses were recorded in 2021, with a higher incidence in men between the ages of 30 and 39. Thanks to antiretroviral therapy (ART), AIDS mortality has decreased significantly, and the U=U (Undetectable=Untransmittable) principle has confirmed the importance of virological suppression in reducing virus transmission.
Despite the success of ART, one of the current challenges is ensuring a good quality of life for PLWH. HIV management is a chronic process that requires continuity of care, treatment adherence, and a multidisciplinary approach to address emerging comorbidities, including cardiovascular, bone, renal, metabolic, oncological, and neuropsychiatric conditions. In this context, active patient involvement becomes essential to improve adherence to therapy and overall health management.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Roma
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Rome, Roma, Italien, 00168
- Fondazione Policlinico Universtiario Agostino Gemelli IRCCS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Consent to participate in the study
- HIV diagnosis
- Current antiretroviral therapy
- - Age >18
- Be able to write, speak, and understand Italian
- Be able to participate in 3 in-person meetings
Exclusion Criteria:
- Refusal to participate in the study
- No HIV diagnosis
- Not currently receiving antiretroviral therapy
- Not being treated at the Infectious Diseases Outpatient Clinic at the Gemelli Hospital in Rome
- Age <18 years
- Non-native Italian speaker
- Unable to attend three in-person meetings
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
score of PLWH
Tidsramme: 10 months
|
to evaluate whether the score of PLWH obtained in the scale measuring engagement increases significantly after the training
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10 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Simona Di Giambenedetto, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i immunsystemet
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- HIV-infektioner
Andre undersøgelses-id-numre
- 6551
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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