- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Roma
-
Rome, Roma, Italia, 00168
- Fondazione Policlinico Universtiario Agostino Gemelli IRCCS
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
10 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Simona Di Giambenedetto, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Blodbårne infeksjoner
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i immunsystemet
- Infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- HIV-infeksjoner
Andre studie-ID-numre
- 6551
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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