Clinical trial NCT03839212: The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men
Official title: Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Cardiometabolic Risk
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-02-15
Enrollment: 18
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. Participants will be interviewed and asked to take part in walking groups.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Number of Eligible Participants Refusing to Participate.
timeFrame: Baseline
measure: Retention Rate
timeFrame: Up to 3 months post intervention
measure: Acceptability of Intervention
timeFrame: Up to week 16
Secondary outcomes:
measure: Change in Cardiometabolic Risk as Measured by Waist Circumference
timeFrame: Baseline, 7 months post intervention
measure: Change in Psychosocial Functioning as Measured by Depression Severity Scale
timeFrame: Baseline, Month 4, Month 7
measure: Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)
timeFrame: Baseline, Month 4, Month 7
measure: Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, Month 4, Month 7
measure: Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale
timeFrame: Baseline, Month 4, Month 7
measure: Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale
timeFrame: Baseline, Month 4, Month 7
measure: Change in Psychosocial Functioning as Measured by the Social Support Received
timeFrame: Baseline, Month 4, Month 7
measure: Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides
timeFrame: Baseline, Month 4, Month 7
measure: Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.
timeFrame: Baseline, Month 4, Month 7
measure: Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)
timeFrame: Baseline, Month 4, Month 7
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Mental Health Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Daniel Jimenez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: