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

Primary Purpose

HIV, Human Immunodeficiency Virus, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Educational Messaging
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zuckerberg San Francisco General HospitalRecruiting
  • University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

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.

The control arm will not receive the educational text messages. They will receive brief monthly surveys via a digital research platform.

Outcomes

Primary Outcome Measures

Proportion of participants with controlled blood pressure
Proportion of participants with blood pressure < 130/80 mmHg as recorded in the electronic health record (EHR).

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2022
Last Updated
March 13, 2023
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05642858
Brief Title
Text Education About Cardiovascular Health and HIV (TEACH-HIV)
Official Title
Text Education About Cardiovascular Health and HIV (TEACH-HIV)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Human Immunodeficiency Virus, Cardiovascular Diseases, Atherosclerosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The control arm will not receive the educational text messages. They will receive brief monthly surveys via a digital research platform.
Intervention Type
Behavioral
Intervention Name(s)
Digital Educational Messaging
Intervention Description
Education via mobile phone text messages for up to 6 months.
Primary Outcome Measure Information:
Title
Proportion of participants with controlled blood pressure
Description
Proportion of participants with blood pressure < 130/80 mmHg as recorded in the electronic health record (EHR).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of cardiovascular risk factors controlled
Description
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.
Time Frame
6 months
Title
Self-perceived cardiovascular risk
Description
Measured by self-report using questions adapted from the patient and provider assessment of lipid management (PALM) registry.
Time Frame
6 months
Title
Systolic blood pressure
Description
Evaluated using EHR data.
Time Frame
6 months
Title
Cholesterol
Description
Non-HDL cholesterol, total cholesterol, LDL cholesterol (in mg/dL), as evaluated using EHR data.
Time Frame
6 months
Title
Physical activity
Description
Minutes/week, measured via self-report using the International Physical Activity Questionnaire (IPAQ).
Time Frame
6 months
Title
Physical activity
Description
Measured via step count.
Time Frame
6 months
Title
Mediterranean diet
Description
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.
Time Frame
6 months
Title
Proportion of current smokers
Description
Measured via self-report.
Time Frame
6 months
Title
Blood sugar control
Description
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.
Time Frame
6 months
Title
Body mass index
Description
Evaluated in kg/m2 using EHR data.
Time Frame
6 months
Title
Proportion of patients on guideline-based therapy
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan McLaughlin, MD, MPH
Phone
628-206-8037
Email
teachhiv@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan McLaughlin, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan McLaughlin, MD, MPH
Email
teachhiv@ucsf.edu
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Mclaughlin, MD, MPH
Email
teachhiv@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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