Human Immunodeficiency VirusHOLAHIVNCT03839212

The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men

A study testing HOLA Component 1, HOLA Component 2 and HOLA Component 3 in people with Human Immunodeficiency Virus and Cardiometabolic Risk, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 midlife and older Latino adults living with HIV. The investigators expect that the participant will be in this study for seven months. Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Human Immunodeficiency Virus, Cardiometabolic Risk
What is being tested?: HOLA Component 1, HOLA Component 2 and HOLA Component 3
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2019to 27 Oct 2020
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
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

are Latino (self-identified);
are age 50+ years;
are male;
are HIV infected but are virologically suppressed (viral load <200 copies/mL);
volunteer informed consent;
have medical clearance by a physician;
expect to stay in Miami for the next 6 months; and
have documented risk of cardiometabolic disease.

Who cannot join

diabetes diagnosis;
at baseline meet criteria for current major depressive disorder or generalized anxiety disorder;
meet criteria for current alcohol or other substance abuse disorders;
have a lifetime history of bipolar disorder or other psychotic disorder;
have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam score <24;
have contraindications to physical activity outlined in the American College of Sports Medicine standards;

Show all 11Show fewer

have high suicide risk i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire);
are unable to complete 10 m walk test;
currently residing in a nursing or group home;
have a terminal physical illness expected to result in the death within one year;
have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention.

Trial locations and contacts

1 site in 1 country.

United States1 site

Jackson Memorial Mental Health Hospital
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention

Conditions: Human Immunodeficiency Virus, Cardiometabolic Risk
Being tested: HOLA Component 1, HOLA Component 2, HOLA Component 3, HOLA Component 4
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HOLA Component 1Behavioural
At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.
HOLA Component 2Behavioural
A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.
HOLA Component 3Behavioural
A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.
HOLA Component 4Behavioural
One booster walking session twice a month for three months post intervention for reinforcement.

Study groups in NCT03839212
Study group	Role	What they receive
Happy Older Latinos are Active (HOLA)	Experimental	A 16-week multi-component, health promotion intervention Receives: Behavioral: HOLA Component 1; Behavioral: HOLA Component 2; Behavioral: HOLA Component 3; Behavioral: HOLA Component 4

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Eligible Participants Refusing to Participate.
Number of eligible participants refusing to participate.
Measured: Baseline
Retention Rate
Retention rate will be reported as the number of participants completing the post-intervention assessment.
Measured: Up to 3 months post intervention
Acceptability of Intervention
As measured by the total number of sessions attended by the participants as a whole.
Measured: Up to week 16

Secondary outcomes (10)

Change in Cardiometabolic Risk as Measured by Waist Circumference
As measured by the number of inches around the participant's waist. A waist circumference of 102 centimetres (40 inches) or more in men is associated with health problems such as type 2 diabetes, heart disease and high blood pressure.
Measured: Baseline, 7 months post intervention
Change in Psychosocial Functioning as Measured by Depression Severity Scale
As measured by a 20-item Center for Epidemiologic Studies Depression (CES-D) scale. The possible range of scores are 0 to 60 with the higher scores indicating the presence of more symptomatology.
Measured: Baseline, Month 4, Month 7
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)
The SF-12v2 is a measure of health related quality of life and provides 2 scores 1) Mental Component Summary Score (MCS) and 2) Physical Component Summary Score (PCS). MCS scores range from 0 to 100, higher scores indicate better mental health related quality of life.
Measured: Baseline, Month 4, Month 7
Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)
severity of depression will be measured by the 9-item PHQ-9. Scores range from 0 to 27. With scores of 1-4 indicating minimal depression and scores of 20-27 indicating severe depression.
Measured: Baseline, Month 4, Month 7
Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale
The 7-item Generalized Anxiety Disorder (GAD-7) scale will be used to measure the severity of anxiety. The scores range from 0 to 21 with scores of 0 to 5 indicating mild anxiety and scores of 15-21 indicating severe anxiety.
Measured: Baseline, Month 4, Month 7
Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale
The 14 item Healthy Families Program Perceived Stress Scale will be used to measure the severity of anxiety. PSS scores can range from 0 to 40 with higher scores indicated higher perception of stress.
Measured: Baseline, Month 4, Month 7
Change in Psychosocial Functioning as Measured by the Social Support Received
The 12 item Multidimensional Scale of Perceived Social support. After calculating the mean score across the categories a mean scale support score from 1 to 2.9 would indicate low support, whereas a mean score of 5.1 to 7 would indicate high support.
Measured: Baseline, Month 4, Month 7
Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides
A total cholesterol value of less than 200 mg/dL (5.18 mmol/L) is desirable and 240 mg/dL (6.22 mmol/L) or higher is high. Average HDL-C level is 40-50 mg/dL (1.0-1.3 mmol/L) for men. Low HDL-C level, increased risk, is less than 40 mg/dL (1.0 mmol/L). Optimal LDL-C levels are less than 100 mg/d while high levels are 160-189 mg/dL (4.15-4.90 mmol/L). Desirable triglyceride levels are less than 150 mg/dL (1.70 mmol/L) while high levels are considered 200-499 mg/dL (2.3-5.6 mmol/L).
Measured: Baseline, Month 4, Month 7
Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.
Normal systolic and diastolic pressure is less than 120 mmHg and 80mmHg, respectively. High systolic and diastolic pressure is 140 mmHg or higher and 90 mmHg or higher, respectively.
Measured: Baseline, Month 4, Month 7
Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)
The normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean a higher chance of getting diabetes. Levels of 6.5% or higher mean diabetes.
Measured: Baseline, Month 4, Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201927 Oct 2020

First posted15 Feb 2019
Study start1 Oct 2019
Primary completion27 Jul 2020
Study completion27 Oct 2020

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 Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03839212
Sponsor's protocol ID: 20181032
Other IDs: U54MD002266
Acronym: HOLAHIV
Status last verified: Jul 2026
First submitted: 8 Feb 2019
Last updated: 31 Jul 2026
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, Weinstein ER, Batsis J. You gotta walk the walk to talk the talk: protocol for a feasibility study of the Happy Older Latino Adults (HOLA) health promotion intervention for older HIV-positive Latino men. Pilot Feasibility Stud. 2023 Feb 28;9(1):32. doi: 10.1186/s40814-023-01262-w.
PubMed 36855194

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention
ClinicalTrials.gov ID: NCT03839212
Acronym / sponsor ID: HOLAHIV / 20181032
Conditions: Human Immunodeficiency Virus, Cardiometabolic Risk
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 1 Oct 2019 (actual)
Primary completion: 27 Jul 2020 (actual)
Study completion: 27 Oct 2020 (actual)
First posted: 15 Feb 2019 (actual)
Results: Posted 16 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Happy Older Latinos are Active (HOLA)	Experimental	Behavioral: HOLA Component 1, Behavioral: HOLA Component 2, Behavioral: HOLA Component 3, Behavioral: HOLA Component 4A 16-week multi-component, health promotion intervention

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (11 listed)

diabetes diagnosis;
at baseline meet criteria for current major depressive disorder or generalized anxiety disorder;
meet criteria for current alcohol or other substance abuse disorders;
have a lifetime history of bipolar disorder or other psychotic disorder;
have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam score <24;

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
HOLA Component 1At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.	Behavioural	Happy Older Latinos are Active (HOLA)
HOLA Component 2A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.	Behavioural	Happy Older Latinos are Active (HOLA)
HOLA Component 3A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.	Behavioural	Happy Older Latinos are Active (HOLA)
HOLA Component 4One booster walking session twice a month for three months post intervention for reinforcement.	Behavioural	Happy Older Latinos are Active (HOLA)

Primary outcome

Number of Eligible Participants Refusing to Participate.
Time frame: Baseline
Number of eligible participants refusing to participate.
Retention Rate
Time frame: Up to 3 months post intervention
Retention rate will be reported as the number of participants completing the post-intervention assessment.
Acceptability of Intervention
Time frame: Up to week 16
As measured by the total number of sessions attended by the participants as a whole.

10 secondary outcomes

Change in Cardiometabolic Risk as Measured by Waist Circumference
Time frame: Baseline, 7 months post intervention
Change in Psychosocial Functioning as Measured by Depression Severity Scale
Time frame: Baseline, Month 4, Month 7
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)
Time frame: Baseline, Month 4, Month 7
Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, Month 4, Month 7
Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale
Time frame: Baseline, Month 4, Month 7
Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale
Time frame: Baseline, Month 4, Month 7
Change in Psychosocial Functioning as Measured by the Social Support Received
Time frame: Baseline, Month 4, Month 7
Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides
Time frame: Baseline, Month 4, Month 7
Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.
Time frame: Baseline, Month 4, Month 7
Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)
Time frame: Baseline, Month 4, Month 7

Results and safety

Results posted to the registry on 16 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Happy Older Latinos Are Active (HOLA)	18	14

Primary outcome: Number of Eligible Participants Refusing to Participate.

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Happy Older Latinos Are Active (HOLA) n = 18
Value	0

Primary outcome: Retention Rate

Time frame: Up to 3 months post intervention. Count of participants. Unit: Participants

Measure	Happy Older Latinos Are Active (HOLA) n = 18
Value	14

Primary outcome: Acceptability of Intervention

Time frame: Up to week 16. Number. Unit: sessions

Measure	Happy Older Latinos Are Active (HOLA) n = 18
Value	111

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Happy Older Latinos Are Active (HOLA)	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): All clinical research activities at the University of Miami were suspended due to the Coronavirus Disease of 2019 (COVID-19) pandemic. As a result, data collection and participant retention were impacted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36855194Jimenez DE, Weinstein ER, Batsis J. You gotta walk the walk to talk the talk: protocol for a feasibility study of the Happy Older Latino Adults (HOLA) health promotion intervention for older HIV-positive Latino men. Pilot Feasibility Stud. 2023 Feb 28;9(1):32. doi: 10.1186/s40814-023-01262-w.
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 HOLA Component 1, HOLA Component 2 and HOLA Component 3 in people with Human Immunodeficiency Virus and Cardiometabolic Risk, 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 8 inclusion and 11 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 31 Jul 2026. 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 16 Aug 2021). 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?

Number of Eligible Participants Refusing to Participate. (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT03839212, 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 31 Jul 2026.