Text Education About Cardiovascular Health and HIV (TEACH-HIV)

Cardiovascular Diseases Clinical Trial

Official title:

Text Education About Cardiovascular Health and HIV (TEACH-HIV)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642858
• Other study ID #: 22-36653
• Secondary ID: T32HL007731
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2023
• Source: University of California, San Francisco
• Contact: Megan McLaughlin, MD, MPH
• Phone: 628-206-8037
• Email: teachhiv[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with HIV (PLWH).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• HIV positive
• At least 40 years of age
• English-speaking

Exclusion Criteria:

• Existing clinical atherosclerotic cardiovascular disease (ASCVD)
• Pregnant
• Unwilling/unable to provide informed consent
• Does not own a smartphone

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Atherosclerosis
• Cardiovascular Diseases
• HIV
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• Digital Educational Messaging
Education via mobile phone text messages for up to 6 months.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with controlled blood pressure	Proportion of participants with blood pressure < 130/80 mmHg as recorded in the electronic health record (EHR).	6 months
Secondary	Number of cardiovascular risk factors controlled	Total of 8 risk factors: diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, blood pressure. Risk factors will be assessed using self-report and EHR data. Risk factor control will be defined based on the American Heart Association's (AHA) Life's Essential 8.	6 months
Secondary	Self-perceived cardiovascular risk	Measured by self-report using questions adapted from the patient and provider assessment of lipid management (PALM) registry.	6 months
Secondary	Systolic blood pressure	Evaluated using EHR data.	6 months
Secondary	Cholesterol	Non-HDL cholesterol, total cholesterol, LDL cholesterol (in mg/dL), as evaluated using EHR data.	6 months
Secondary	Physical activity	Minutes/week, measured via self-report using the International Physical Activity Questionnaire (IPAQ).	6 months
Secondary	Physical activity	Measured via step count.	6 months
Secondary	Mediterranean diet	Measured using the Mediterranean Eating Pattern for Americans (MEPA) tool, as scored by AHA's Life's Essential 8. Score ranges 0-16, with higher scores representing better outcomes.	6 months
Secondary	Proportion of current smokers	Measured via self-report.	6 months
Secondary	Blood sugar control	Evaluated using EHR data on hemoglobin A1c and fasting blood glucose. Blood sugar control will be defined based on the AHA's Life's Essential 8 definitions.	6 months
Secondary	Body mass index	Evaluated in kg/m2 using EHR data.	6 months
Secondary	Proportion of patients on guideline-based therapy	Proportion of patients on anti-hypertensive medications, statins, and aspirin, among those who meet criteria for therapy based on American Heart Association / American College of Cardiology (AHA/ACC) guidelines.	6 months