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

Sponsor
University of California, San Francisco (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05642858
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
260
1
2
16
16.2

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital Educational Messaging
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Text Education About Cardiovascular Health and HIV (TEACH-HIV)
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Self-perceived cardiovascular risk [6 months]

    Measured by self-report using questions adapted from the patient and provider assessment of lipid management (PALM) registry.

  3. Systolic blood pressure [6 months]

    Evaluated using EHR data.

  4. Cholesterol [6 months]

    Non-HDL cholesterol, total cholesterol, LDL cholesterol (in mg/dL), as evaluated using EHR data.

  5. Physical activity [6 months]

    Minutes/week, measured via self-report using the International Physical Activity Questionnaire (IPAQ).

  6. Physical activity [6 months]

    Measured via step count.

  7. 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.

  8. Proportion of current smokers [6 months]

    Measured via self-report.

  9. 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.

  10. Body mass index [6 months]

    Evaluated in kg/m2 using EHR data.

  11. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Francisco San Francisco California United States 94115

Sponsors and Collaborators

  • University of California, San Francisco
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Megan McLaughlin, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT05642858
Other Study ID Numbers:
  • 22-36653
  • T32HL007731
First Posted:
Dec 8, 2022
Last Update Posted:
Feb 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2023