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

NCT07077642 | Enrolling By Invitation

• 1 other identifier: MUSA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 11

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

Conditions

HIV; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Evaluation of the diagnostic performance of multidimensional screening test in identifying alterations in considered domains in patients with hiv

  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)

  At enrollment

Eligibility Criteria

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

Study Population

HIV patients

You may qualify if:

• Age 18 years and older
• Confirmed HIV infection
• Good understanding of the Italian language
• Signature of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Giovanni Di Perri: lead

Study Sites (11)

Università degli Studi di Genova

Genova, Genova, Italy

Location

ASST Fatebenefratell - Sacco, Ospedale L. Sacco

Milan, Milano, Italy

Location

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

Milan, Milano, Italy

Location

Unità di Malattie Infettive, IRCCS San Raffaele

Milan, Milano, Italy

Location

Ospedale Amedeo di Savoia

Torino, Torino, 10149, Italy

Location

UOC Malattie Infettive, Università di Bari "Aldo Moro", AOU Policlinico di Bari

Bari, Italy

Location

UOC Malattie Infettive, Arnas Garibaldi

Catania, Italy

Location

Malattie Infettive ed Urgenze Infettivologiche, Presidio Ospedaliero Cotugno - Azienda Ospedaliera dei Colli, Napoli

Napoli, Italy

Location

UOC Malattie Infettive e Tropicali, Azienda Ospedale Università di Padova

Padua, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma

Roma, Italy

Location

SS Immunodeficienza, Azienda Ospedaliero Universitaria di Sassari

Sassari, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 22, 2025
• Study Start: September 2, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

IT (11)