Clinical trial NCT05752578: Perspective Memory and Executive Functions in HIV+ Patients
Official title: Influence of Hot and Cold Cognition on Prospective Memory in HIV+ Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We expect the population with HIV and the healthy population compared by age (between 40 and 60 years old for the majority) and schooling (majority high school graduates). We expect a virologically suppressed HIV population with good adherence to antiretroviral therapy and deficits in prospective memory compared with the healthy population.

Brief summary: The primary goal of this observational study is to evaluate prospective memory in HIV+ patients compared to healthy subjects. The secondary goal is to examine the relationship between prospective memory and Hot Cognition (mechanical cognitive abilities) and Cold Cognition (cognitive abilities supported by emotion and social perception). The main questions it aims to answer are:

* Do HIV+ patients have more impaired prospective memory than healthy subjects?
* Is there a greater influence of Hot Cognition on prospective memory than Cold Cognition? Participants will undergo a battery of neuropsychological tests: Memory for Intentions Screening Test (MIST), Montreal Cognitive Assessment (MOCA), Interpersonal Reactivity Index and Modified Five Point Test.


Eligibility criteria: Inclusion Criteria HIV+:

* consent to participate in the study
* diagnosis of HIV
* Current antiretroviral therapy
* age \>18 years
* native Italian speaker

Exclusion Criteria HIV+:

* age \<18 years
* presence of major psychiatric disorders within the past 6 months
* additional neurological conditions that may impair the performance of the tests (Alzheimer's disease, Outcomes of head-brain trauma, cerebrovascular episodes)
* Alcohol and drug addiction within the past 6 months
* Additional medical conditions that may impair neurocognitive profile and functional abilities (cerebrovascular damage, cardiac problems with functional impairment, severe liver disease)

Inclusion Criteria HIV- :

* consent to participate in the study
* Absence of HIV infection (HIV-RNA negative)
* age \>18 years
* native speaker of Italian

Exclusion Criteria HIV+ :

* age \<18 years
* presence of major psychiatric disorders within the past 6 months
* additional neurological conditions that may impair the performance of the tests (Alzheimer's disease, Outcomes of head-brain trauma, cerebrovascular episodes)
* Alcohol and drug addiction within the past 6 months
* additional medical conditions that may impair neurocognitive profile and functional abilities (cerebrovascular damage, heart problems with functional impairment, severe liver disease).

Primary outcomes:
measure: Prospective memory in HIV+ patients and healthy subjects
timeFrame: 1 year
Secondary outcomes:
measure: Influence of global cognitive performance on prospective memory
timeFrame: 1 year
measure: Influence of hot cognition on perspective memory
timeFrame: 1 year
measure: Influence of cold cognition on perspective memory
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References: