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

Human Immunodeficiency Virus Clinical Trial

— HOLAHIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839212
• Other study ID #: 20181032
• Secondary ID: U54MD002266
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 27, 2020

Study information

• Verified date: July 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 27, 2020
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cardiometabolic Risk
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• HOLA Component 1
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 2
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 3
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 4
One booster walking session twice a month for three months post intervention for reinforcement.

Locations

Country	Name	City	State
United States	Jackson Memorial Mental Health Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Eligible Participants Refusing to Participate.	Number of eligible participants refusing to participate.	Baseline
Primary	Retention Rate	Retention rate will be reported as the number of participants completing the post-intervention assessment.	Up to 3 months post intervention
Primary	Acceptability of Intervention	As measured by the total number of sessions attended by the participants as a whole.	Up to week 16
Secondary	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.	Baseline, 7 months post intervention
Secondary	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.	Baseline, Month 4, Month 7
Secondary	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.	Baseline, Month 4, Month 7
Secondary	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.	Baseline, Month 4, Month 7
Secondary	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.	Baseline, Month 4, Month 7
Secondary	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.	Baseline, Month 4, Month 7
Secondary	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.	Baseline, Month 4, Month 7
Secondary	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).	Baseline, Month 4, Month 7
Secondary	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.	Baseline, Month 4, Month 7
Secondary	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.	Baseline, Month 4, Month 7