Validation of a Multidimensional Scale for the Detection of Health Needs in People With HIV

• Conditions: HIV; Quality of Life

• Registration Number: NCT07077642
• Lead Sponsor: Giovanni Di Perri

Brief Summary

The primary objective is to evaluate the diagnostic performance of the multidimensional screening test in identifying alterations in the domains considered in people with HIV, in order to improve the predictivity of disorders, ensure better care and consequently improve the quality of life of people with HIV

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-02
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-07-11
• Study First Posted: 2025-07-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-15
• Primary Completion: 2025-10
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 18 years and older

  • Confirmed HIV infection
  • Good understanding of the Italian language
  • Signature of informed consent
  • Inclusion of at least 33% women and at least 33% people older than 50 years of age

Exclusion Criteria

• Acute ongoing diseases that, in the opinion of the investigators, may affect the performance of the tests (bacterial or viral infections, neoplasms under active chemotherapy treatment)

  • Dementia or other severe neurodegenerative/neurocognitive disorders.
  • Individuals unable to express consent independently and/or supported by protective legal figures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the diagnostic performance of multidimensional screening test in identifying alterations in considered domains in patients with hiv	At enrollment	Composite endpolint for each domani: 1. Cognitive impairment (using the Brief Neurocognitive Screening Test); 2. Depressive symptoms (using the Patient Health Questionnaire-9); 3. anxiety symptoms (using the General Anxiety Disorder-7 test); 4. sleep quality (using the Pittsburgh Sleep Quality Index); 5. quality of life (using the EQ-5D-5L); 6. functional test (using the Advanced Instrumental Activities of Daily Living Scale); 7. nutritional (using the Mini Nutritional Assessment (MNA) - short form); 8. socio-economic (using detailed questions); 9. stigma (using HIV Stigma Scale - 12 item version, Karolinska Institute); 10. comorbidities (checking in the medical records); 11. polytherapy (checking in the medical records); 12. alcool or drug use (using Audit-C and Brief Substance Craving Scale)

Trial Locations

Locations (11)

UOC Malattie Infettive, Università di Bari "Aldo Moro", AOU Policlinico di Bari; 🇮🇹 Bari, Italy

UOC Malattie Infettive, Arnas Garibaldi; 🇮🇹 Catania, Italy

Università degli Studi di Genova; 🇮🇹 Genova, Italy

ASST Fatebenefratell - Sacco, Ospedale L. Sacco; 🇮🇹 Milano, Italy

Clinica delle Malattie Infettive e Tropicali, Dipartimento di Scienze della Salute, Università degli Studi di Milano, ASST Santi Paolo e Carlo; 🇮🇹 Milano, Italy

Unità di Malattie Infettive, IRCCS San Raffaele; 🇮🇹 Milano, Italy

Malattie Infettive ed Urgenze Infettivologiche, Presidio Ospedaliero Cotugno - Azienda Ospedaliera dei Colli, Napoli; 🇮🇹 Napoli, Italy

UOC Malattie Infettive e Tropicali, Azienda Ospedale Università di Padova; 🇮🇹 Padova, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma; 🇮🇹 Roma, Italy

SS Immunodeficienza, Azienda Ospedaliero Universitaria di Sassari; 🇮🇹 Sassari, Italy

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