Happy Older Latinos Are Active - Cognitive Decline (HOLA-CD)

October 2, 2025 updated by: Daniel Enrique Jimenez, University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HOLA Group
Participants in this group will receive a multicomponent intervention for 16 weeks.
Behavioral: Happy Older Latinos are Active (HOLA)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 16 weeks
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.
Baseline, 16 weeks
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.
Baseline, 16 weeks
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.
Baseline, 16 weeks
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.
Baseline, 16 weeks
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.
Baseline, 16 weeks
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.
Baseline, 16 weeks
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.
Baseline, 16 weeks
Changes in Adiponectin
Time Frame: Baseline, 16 weeks
Adiponectin will be assessed from blood samples measured by ng/ml
Baseline, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Daniel Jimenez, Ph.D., University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

March 12, 2025

Study Completion (Actual)

March 12, 2025

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Estimated)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20201202
  • U54MD002266-14S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Decline

Clinical Trials on Happy Older Latinos are Active (HOLA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe