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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Atherosclerosis; HIV; Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: Digital Educational Messaging

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan McLaughlin, MD, MPH; Phone Number: 628-206-8037; Email: teachhiv@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • Zuckerberg San Francisco General Hospital
      • Contact: Megan Mclaughlin, MD, MPH; Email: teachhiv@ucsf.edu
    • San Francisco, California, United States, 94115
      • Recruiting
      • University of California San Francisco
      • Contact: Megan Mclaughlin, MD, MPH; Email: teachhiv@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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.	Behavioral: Digital Educational Messaging; Education via mobile phone text messages for up to 6 months.
No Intervention: Control Arm; The control arm will not receive the educational text messages. They will receive brief monthly surveys via a digital research platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Self-perceived cardiovascular risk	Measured by self-report using questions adapted from the patient and provider assessment of lipid management (PALM) registry.	6 months
Systolic blood pressure	Evaluated using EHR data.	6 months
Cholesterol	Non-HDL cholesterol, total cholesterol, LDL cholesterol (in mg/dL), as evaluated using EHR data.	6 months
Physical activity	Minutes/week, measured via self-report using the International Physical Activity Questionnaire (IPAQ).	6 months
Physical activity	Measured via step count.	6 months
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
Proportion of current smokers	Measured via self-report.	6 months
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
Body mass index	Evaluated in kg/m2 using EHR data.	6 months
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Megan McLaughlin, MD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Vascular Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; Arteriosclerosis; Arterial Occlusive Diseases; HIV Infections; Cardiovascular Diseases; Acquired Immunodeficiency Syndrome; Atherosclerosis
• Other Study ID Numbers: 22-36653; T32HL007731 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No