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

Not Applicable

Recruiting

• Conditions: HIV; Atherosclerosis; Human Immunodeficiency Virus; Cardiovascular Diseases
• Interventions: Behavioral: Digital Educational Messaging

• Registration Number: NCT05642858
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-08
• Study Start: 2023-03-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-12-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Digital Educational Messaging	The intervention arm will receive education about HIV and heart disease risk via mobile phone text messages for up to 6 months. They will receive the text messages 3-5 times per week. The messages will include information about HIV and risk of heart disease and information about how to reduce heart disease risk. The intervention arm will also receive brief monthly surveys via a digital research platform.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with controlled blood pressure	6 months	Proportion of participants with blood pressure \< 130/80 mmHg as recorded in the electronic health record (EHR).

Secondary Outcome Measures

Name	Time	Method
Proportion of current smokers	6 months	Measured via self-report.
Self-perceived cardiovascular risk	6 months	Measured by self-report using questions adapted from the patient and provider assessment of lipid management (PALM) registry.
Systolic blood pressure	6 months	Evaluated using EHR data.
Number of cardiovascular risk factors controlled	6 months	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.
Proportion of patients on guideline-based therapy	6 months	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.
Cholesterol	6 months	Non-HDL cholesterol, total cholesterol, LDL cholesterol (in mg/dL), as evaluated using EHR data.
Physical activity	6 months	Measured via step count.
Mediterranean diet	6 months	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.
Body mass index	6 months	Evaluated in kg/m2 using EHR data.
Blood sugar control	6 months	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.

Trial Locations

Locations (2)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States