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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD002266-14S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HOLA Group | Experimental | Participants in this group will receive a multicomponent intervention for 16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Completing the Study | Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Jimenez, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39133532 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HOLA Group | Participants in this group will receive a multicomponent intervention for 16 weeks. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HOLA Group | Participants in this group will receive a multicomponent intervention for 16 weeks. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Completing the Study | Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment. | Posted | Number | Percentage of participants | 16 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HOLA Group | Participants in this group will receive a multicomponent intervention for 16 weeks. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Jimenez | University of Miami | 305-243-2776 | dej18@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2021 | Mar 20, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 26, 2021 | Sep 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 16 weeks |
| Changes in Adiponectin | Adiponectin will be assessed from blood samples measured by ng/ml | Baseline, 16 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | MET-minutes per week | Baseline, 16 weeks |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pg/ml | Baseline, 16 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/ml | Baseline, 16 weeks |
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| Secondary | Changes in Adiponectin | Adiponectin will be assessed from blood samples measured by ng/ml | Posted | Mean | Standard Deviation | ng/ml | Baseline, 16 weeks |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| Trail Making Test (TMT) B-16 weeks |
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| brain derived neurotrophic factor (BDNF) 16 weeks |
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| vascular endothelial growth factor (VEG-F) baseline |
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| vascular endothelial growth factor (VEG-F) 16 weeks |
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| Title | Measurements |
|---|---|
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| insulin like growth factor (IGF-1) 16 weeks |
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