HOLA Program for Preventing Cognitive Decline

(HOLA-CD Trial)

Overseen By Natalie Ferras, MS, MHC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Neurodegenerative disorders, Cognitive impairment, Brain trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best ways to prevent memory and thinking problems in Latino adults over 50 with controlled HIV viral levels. Participants will engage in the Happy Older Latinos are Active (HOLA) multicomponent program for 16 weeks to assess its impact on brain health. This trial suits Latino individuals with HIV who do not have neurodegenerative disorders and can participate in physical activities. As an unphased trial, it offers participants the chance to contribute to important research that could enhance brain health strategies for the Latino community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the HOLA program is safe for preventing cognitive decline in midlife and older Latino adults living with HIV?

Research shows that the Happy Older Latinos are Active (HOLA) program is generally easy for participants to handle. Community health workers lead this program, which aims to prevent mental health issues and boost brain function. Previous studies have found that participants find HOLA practical and well-received, with no serious side effects reported. This suggests the program is safe, focusing on improving health without causing major negative effects. Although the program is still new, the evidence so far supports its safety in preventing memory and thinking problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HOLA Program is unique because it focuses on a multicomponent intervention that encourages physical activity and social engagement among older Latino adults to prevent cognitive decline. Unlike standard treatments for cognitive decline, which often involve medications like cholinesterase inhibitors or lifestyle changes focused individually on diet or exercise, HOLA combines several elements into one comprehensive program. Researchers are excited about this approach because it addresses cognitive health holistically, potentially offering a more sustainable and culturally tailored method to maintain cognitive function in aging populations.

What evidence suggests that the HOLA program is effective for preventing cognitive decline in midlife and older Latino adults living with HIV?

Research has shown that the Happy Older Latinos are Active (HOLA) program, which participants in this trial will receive, might help prevent memory and thinking problems in older Latino adults. A small initial study found that HOLA was not only feasible and well-received but also showed promise in improving mental and emotional health. Community health workers lead activities in the program, which has been shown to boost mental well-being and may help prevent common mental health issues. Although HOLA is a new program, early results suggest it could effectively lower the risks of age-related memory decline, especially in Latino adults living with HIV. ^{1 2 4 6 7}

Who Is on the Research Team?

Daniel Jimenez, Ph.D.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for Latino adults over 50 living with HIV who have their viral load under control. They must be able to walk and give informed consent, but can't join if they're undergoing cancer treatment, have significant hearing or vision loss, a history of serious brain trauma, any neurodegenerative diseases like Alzheimer's, or conditions that make exercise unsafe.

Inclusion Criteria

I am 50 years old or older.

I have given my consent to participate.

I am HIV positive with a viral load under 200 copies/mL.

Exclusion Criteria

I have been diagnosed with a neurodegenerative disorder or dementia.

I cannot walk 10 meters by myself.

I do not have conditions affecting my thinking or senses, nor am I currently on cancer treatment, and I've never had a severe brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multicomponent intervention for 16 weeks led by a community health worker to help prevent cognitive decline

16 weeks

Follow-up

Participants are monitored for changes in neurocognitive impairment, physical activity, psychosocial functioning, biomarkers of cognition, anxiety, and depression

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Happy Older Latinos are Active (HOLA)

Trial Overview The study tests the 'Happy Older Latinos are Active (HOLA)' program to prevent memory loss and decline in mental function among older Latino adults with HIV. It aims to find effective strategies for maintaining cognitive health in this population.

How Is the Trial Designed?

Group I: HOLA Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4683729/

The Happy Older Latinos are Active (HOLA) health promotion ... HOLA is a newly developed intervention that uses a community health worker (CHW) to lead a health promotion program in order to prevent common mental disorders.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03839212

The Happy Older Latinos Are Active (HOLA) Health ... The purpose of this study is to examine the feasibility of an intervention to prevent chronic diseases like diabetes, high blood pressure, and obesity in ...

3. academic.oup.com academic.oup.com/gerontologist/article/65/6/gnaf102/8071334

Improving Cognitive and Psychological Functioning in Older ... This pilot study evaluated the feasibility, acceptability, and preliminary intervention effects of the Happy Older Latinos are Active (HOLA) physical activity ...

4. psycnet.apa.org psycnet.apa.org/record/2025-50533-001

“Caminando y socializando con Happy Older Latinos are ... This study sought to evaluate the feasibility, acceptability, and preliminary efficacy of the Happy Older Latinos are Active (HOLA) health promotion ...

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074824003615

Preventing Cognitive Decline in Older Latino Adults With ... Older Latino adults with HIV are at increased risk for mild cognitive impairment and earlier onset of aging-related cognitive decline. Improvements in cognitive ...

6. researchprotocols.org researchprotocols.org/2024/1/e55507/

Preventing Cognitive Decline in Older Latino Adults With ... This study aims to (1) determine the feasibility and acceptability of an adapted version of HOLA aimed at improving cognitive functioning among older Latino ...

7. d-nb.info d-nb.info/1118316703/34

The Happy Older Latinos are Active (HOLA) health ... Happy Older Latinos are Active (HOLA) is a newly developed intervention that uses a community health worker. (CHW) to lead a health promotion program in order ...