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Completed

NCT Number: NCT04791709

Happy Older Latinos Are Active - Cognitive Decline

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.

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Key information

Conditions

Cognitive Decline Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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 Telephone Interview for Cognitive Status (TICS) score less than or equal to 30;
  • 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).

Treatment and study plan

Happy Older Latinos are Active (HOLA)

Behavioral

HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.

Primary outcomes

  1. Percentage of Participants Completing the Study

    Time frame: 16 weeks

    Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.

Secondary outcomes

  1. Changes in Neurocognitive Impairment as Measured by the Trails Making Test

    Time frame: Baseline, 16 weeks

    Trail Making Test (TMT). Time to accurately complete Part A and Part B. The TMT measures neurocognitive functioning and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment measured in seconds.

  2. Changes in Neurocognitive Impairment as Measured by the WAIS-IV Digit Span

    Time frame: Baseline, 16 weeks

    The Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) asks participants to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory. Each correct response earns 1 point, and the total raw score is converted to a scaled score ranging from 1 to 19. Higher scores indicate better cognitive performance; lower scores reflect increased neurocognitive impairment.

  3. Changes in Physical Activity as Measured by the Global Physical Activity Questionnaire (GPAQ)

    Time frame: Baseline, 16 weeks

    The Global Physical Activity Questionnaire (GPAQ) scoring is based on the amount of time a person spends being physically active in a typical week. It looks at three areas: activity at work or during daily tasks (including heavy lifting, digging, carrying loads, or light activities like cleaning); traveling from place to place (like walking or cycling); and recreational activities (such as exercise, sports, or active hobbies). Each activity is converted into a standard unit called MET-minutes (Metabolic Equivalent of Task). This allows different types of activity to be compared on the same scale. The total MET-minutes per week are calculated by multiplying: Minutes per day × Days per week × MET value with higher scores indicating greater levels of activity.

  4. Changes in Depression as Measured by the PHQ-9

    Time frame: Baseline, 16 weeks

    The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that measures depression severity. The total score ranges from 0-27 with higher scores indicating more severe depression.

  5. Changes in Anxiety as Measured by the GAD-7

    Time frame: Baseline, 16 weeks

    The Generalized Anxiety Disorder (GAD-7) is a 7 item questionnaire that measures anxiety severity. The total score ranges from 0-21 with higher scores indicating more severe anxiety.

  6. Changes in Psychosocial Functioning as Measured by the MSPSS

    Time frame: Baseline, 16 weeks

    The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12 item questionnaire that measures perceived social support. The total score ranges from 1-84 with higher scores indicating more perceived social support.

  7. Changes in Biomarkers of Cognition

    Time frame: Baseline, 16 weeks

    Biomarkers of cognition including interleukin-15, brain derived neurotrophic factor (BDNF), and vascular endothelial growth factor (VEG-F) reported in pg/ml will be assessed from blood samples.

  8. Changes in Biomarkers of Cognition Levels

    Time frame: Baseline, 16 weeks

    Biomarkers of cognition levels including irisin and insulin like growth factor (IGF-1) reported in ng/ml will be assessed from blood samples.

  9. Changes in Adiponectin

    Time frame: Baseline, 16 weeks

    Adiponectin will be assessed from blood samples measured by ng/ml

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Preventing Cognitive Decline in HIV-infected Latinos Through a Culturally Tailored Health Promotion Intervention (HOLA)

Acronym: HOLA-CD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2021
Registry last updated
Oct 20, 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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