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

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

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Key information

Conditions

HIV Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Università degli Studi di Genova, Genova, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: At enrollment
Composite endpolint for each domani:
- Cognitive impairment (using the Brief Neurocognitive Screening Test)
- Depressive symptoms (using the Patient Health Questionnaire-9)
- anxiety symptoms (using the General Anxiety Disorder-7 test)
- sleep quality (using the Pittsburgh Sleep Quality Index)
- quality of life (using the EQ-5D-5L)
- functional test (using the Advanced Instrumental Activities of Daily Living Scale)
- nutritional (using the Mini Nutritional Assessment (MNA) - short form)
- socio-economic (using detailed questions)
- stigma (using HIV Stigma Scale - 12 item version, Karolinska Institute)
- comorbidities (checking in the medical records)
- polytherapy (checking in the medical records)
- alcool or drug use (using Audit-C and Brief Substance Craving Scale)

Sponsors and collaborators

Lead sponsor

Giovanni Di Perri

Other

Registry information

Acronym: MUSA

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 22, 2025
Registry last updated: Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed