Happy Older Latinos Are Active - Cognitive Decline

NCT04791709 | Completed Results

• 2 other identifiers: 20201202U54MD002266-14S1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Completing the Study

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

  16 weeks

Secondary Outcomes (9)

• Changes in Neurocognitive Impairment as Measured by the Trails Making Test

  Baseline, 16 weeks

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

  Baseline, 16 weeks

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

  Baseline, 16 weeks

• Changes in Depression as Measured by the PHQ-9

  Baseline, 16 weeks

• Changes in Anxiety as Measured by the GAD-7

  Baseline, 16 weeks

Study Arms (1)

HOLA Group

EXPERIMENTAL

Participants in this group will receive a multicomponent intervention for 16 weeks.

Behavioral: Happy Older Latinos are Active (HOLA)

Interventions

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.

HOLA Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Jimenez DE, Ross EJ, Weinstein E, Gouse H, Pan Y, Martinez Garza D, Burke SL, Joo JH, Behar-Zusman V. Preventing Cognitive Decline in Older Latino Adults With HIV Through a Culturally Tailored Health Promotion Intervention: Protocol for a Single-Arm Pilot Trial. JMIR Res Protoc. 2024 Aug 12;13:e55507. doi: 10.2196/55507.

  PMID: 39133532 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Daniel Jimenez
• Organization: University of Miami

dej18@miami.edu

305-243-2776

Study Officials

• Daniel Jimenez, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: February 1, 2022
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)