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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07077642

Acronym

MUSA

Enrollment

200

Registered

2025-07-22

Start date

2024-09-02

Completion date

2025-12-31

Last updated

2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Quality of Life

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Italy

Outcome results