Clinical trial NCT04791709: Happy Older Latinos Are Active - Cognitive Decline
Official title: Preventing Cognitive Decline in HIV-infected Latinos Through a Culturally Tailored Health Promotion Intervention (HOLA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: National Institute on Aging (NIA)
First posted: 2021-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older Latino adults living with HIV.

Detailed description: The purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older Latino adults living with HIV. It assesses the feasibility of running a health promotion program, led by a community health worker (CHW) intended to help prevent cognitive decline (loss of memory and/or functioning) through a culturally tailored health promotion intervention . Eligible participants will be Latino/Hispanic individuals 50 years of age or older, living with HIV, who may be at risk of developing chronic diseases such as dementia and Alzherimer's.

Eligibility criteria: Inclusion Criteria:

* are Latino (self-identified);
* are age 50+;
* are HIV infected but are virologically suppressed (viral load \<200 copies/mL);
* volunteer informed consent

Exclusion Criteria:

* have diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's disease, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam score \<24;
* have other conditions that could impact cognitive functioning or testing (e.g., legally blind or deaf), currently undergoing radiation or chemotherapy, a history of brain trauma with a loss of consciousness greater than 30 minutes.
* have contraindications to physical activity outlined in the American College of Sports Medicine standards or severe medical illness that precludes them from safely participating in a health promotion intervention.
* are unable to complete 10-meter walk test.
* have plans to move outside of the Miami metropolitan area within the next 6 months or are not living in stable housing (e.g. group home).

Primary outcomes:
measure: Percentage of participants completing the study
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Changes in neurocognitive impairment as measured by the Trails Making Test
timeFrame: Baseline, 16 weeks
measure: Changes in neurocognitive impairment as measured by the WAIS-IV Digit Span
timeFrame: Baseline, 16 weeks
measure: Changes in physical activity as measured by the GPAQ
timeFrame: Baseline, 16 weeks
measure: Changes in depression as measured by the PHQ-9
timeFrame: Baseline, 16 weeks
measure: Changes in anxiety as measured by the GAD-7
timeFrame: Baseline, 16 weeks
measure: Changes in psychosocial functioning as measured by the MSPSS
timeFrame: Baseline, 16 weeks
measure: Changes in biomarkers of cognition
timeFrame: Baseline, 16 weeks
measure: Changes in biomarkers of cognition levels
timeFrame: Baseline, 16 weeks
measure: Changes in adiponectin
timeFrame: Baseline, 16 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Daniel Jimenez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: