Cognitive DeclineHOLA-CDNCT04791709
Happy Older Latinos Are Active - Cognitive Decline
A study testing Happy Older Latinos are Active (HOLA) in people with Cognitive Decline, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Happy Older Latinos are Active (HOLA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 12 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are Latino (self-identified);
- are age 50+;
- are HIV infected but are virologically suppressed (viral load <200 copies/mL);
- volunteer informed consent
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Happy Older Latinos are Active (HOLA)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happy Older Latinos are Active (HOLA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HOLA Group | Experimental | Participants in this group will receive a multicomponent intervention for 16 weeks. Receives: Behavioral: Happy Older Latinos are Active (HOLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Completing the Study
Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.
Measured: 16 weeks
Secondary outcomes (9)
Changes in Neurocognitive Impairment as Measured by the Trails Making Test
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.
Measured: Baseline, 16 weeks
Changes in Neurocognitive Impairment as Measured by the WAIS-IV Digit Span
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.
Measured: Baseline, 16 weeks
Changes in Physical Activity as Measured by the Global Physical Activity Questionnaire (GPAQ)
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.
Measured: Baseline, 16 weeks
Changes in Depression as Measured by the PHQ-9
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.
Measured: Baseline, 16 weeks
Changes in Anxiety as Measured by the GAD-7
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.
Measured: Baseline, 16 weeks
Changes in Psychosocial Functioning as Measured by the MSPSS
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.
Measured: Baseline, 16 weeks
Changes in Biomarkers of Cognition
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.
Measured: Baseline, 16 weeks
Changes in Biomarkers of Cognition Levels
Biomarkers of cognition levels including irisin and insulin like growth factor (IGF-1) reported in ng/ml will be assessed from blood samples.
Measured: Baseline, 16 weeks
Changes in Adiponectin
Adiponectin will be assessed from blood samples measured by ng/ml
Measured: Baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Feb 2022
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Daniel Enrique Jimenez, University of Miami
- Investigators
- Daniel Jimenez, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791709
- Sponsor's protocol ID
- 20201202
- Other IDs
- U54MD002266-14S1
- Acronym
- HOLA-CD
- Status last verified
- Oct 2025
- First submitted
- 5 Mar 2021
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39133532
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Cognitive Decline in HIV-infected Latinos Through a Culturally Tailored Health Promotion Intervention (HOLA)
- ClinicalTrials.gov ID
- NCT04791709
- Acronym / sponsor ID
- HOLA-CD / 20201202
- Conditions
- Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOLA Group | Experimental | Behavioral: Happy Older Latinos are Active (HOLA)Participants in this group will receive a multicomponent intervention for 16 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- are Latino (self-identified);
- are age 50+;
- are HIV infected but are virologically suppressed (viral load <200 copies/mL);
- volunteer informed consent
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | HOLA Group |
Primary outcome
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.
9 secondary outcomes
Changes in Neurocognitive Impairment as Measured by the Trails Making Test
Time frame: Baseline, 16 weeks
Changes in Neurocognitive Impairment as Measured by the WAIS-IV Digit Span
Time frame: Baseline, 16 weeks
Changes in Physical Activity as Measured by the Global Physical Activity Questionnaire (GPAQ)
Time frame: Baseline, 16 weeks
Changes in Depression as Measured by the PHQ-9
Time frame: Baseline, 16 weeks
Changes in Anxiety as Measured by the GAD-7
Time frame: Baseline, 16 weeks
Changes in Psychosocial Functioning as Measured by the MSPSS
Time frame: Baseline, 16 weeks
Changes in Biomarkers of Cognition
Time frame: Baseline, 16 weeks
Changes in Biomarkers of Cognition Levels
Time frame: Baseline, 16 weeks
Changes in Adiponectin
Time frame: Baseline, 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39133532Jimenez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Jimenez, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happy Older Latinos are Active (HOLA) in people with Cognitive Decline, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Completing the Study (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.