HIVMUSANCT07077642
Validation of a Multidimensional Scale for the Detection of Health Needs in People With HIV
An observational study of HIV and Quality of Life, run by Giovanni Di Perri at 11 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Quality of Life
- How many people
- 200 participants
- Where
- 11 sitesItaly
- Study dates
- 2 Sep 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Italy11 sites
UOC Malattie Infettive, Università di Bari "Aldo Moro", AOU Policlinico di Bari
Bari
UOC Malattie Infettive, Arnas Garibaldi
Catania
Università degli Studi di Genova
Genova, Genova
ASST Fatebenefratell - Sacco, Ospedale L. Sacco
Milan, Milano
Clinica delle Malattie Infettive e Tropicali, Dipartimento di Scienze della Salute, Università degli Studi di Milano, ASST Santi Paolo e Carlo
Milan, Milano
Unità di Malattie Infettive, IRCCS San Raffaele
Milan, Milano
Malattie Infettive ed Urgenze Infettivologiche, Presidio Ospedaliero Cotugno - Azienda Ospedaliera dei Colli, Napoli
Naples
UOC Malattie Infettive e Tropicali, Azienda Ospedale Università di Padova
Padova
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma
Roma
SS Immunodeficienza, Azienda Ospedaliero Universitaria di Sassari
Sassari
Ospedale Amedeo di Savoia
Torino, Torino, 10149
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the diagnostic performance of multidimensional screening test in identifying alterations in considered domains in patients with hiv
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)
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start2 Sep 2024
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giovanni Di Perri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giovanni Di Perri, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077642
- Sponsor's protocol ID
- MUSA
- Acronym
- MUSA
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Multidimensional Scale for the Detection of Health Needs in People With HIV
- ClinicalTrials.gov ID
- NCT07077642
- Acronym / sponsor ID
- MUSA / MUSA
- Conditions
- HIV, Quality of Life
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Giovanni Di PerriUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV patients
Key inclusion criteria (5 listed)
- Age 18 years and older
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Quality of Life, run by Giovanni Di Perri at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the diagnostic performance of multidimensional screening test in identifying alterations in considered domains in patients with hiv (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.