Happy Older Latinos Are Active - Cognitive Decline

NCT ID: NCT04791709

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2025-03-12

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.

Conditions

Cognitive Decline

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HOLA Group

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

Group Type: EXPERIMENTAL

Happy Older Latinos are Active (HOLA)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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 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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Daniel Enrique Jimenez

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Jimenez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39133532 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54MD002266-14S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20201202

Identifier Type: -

Identifier Source: org_study_id