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Search / Trial NCT06001814

Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV

Launched by MASSACHUSETTS GENERAL HOSPITAL · Aug 14, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial, called "Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV," is looking at how mindfulness practices can help older adults living with HIV reduce their stress and improve their heart health. People with HIV are at a higher risk for heart disease, often due to both lifestyle factors and inflammation caused by the virus. The study will create a new program called "One Mind One Heart" that will use text messages to guide participants through mindfulness exercises aimed at lowering stress and encouraging healthier behaviors.

To be eligible for this trial, participants need to be at least 50 years old, have a clinical diagnosis of HIV, be currently taking HIV medication, and show signs of elevated stress. They should also have at least one risk factor for heart disease, like high blood pressure or diabetes, and must have access to a phone that can receive text messages. During the trial, participants will receive support through the program and share their experiences, which will help researchers understand how well it works and how to improve it. It's an exciting opportunity for older adults with HIV to potentially improve their health while contributing to important research.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. age ≥50 years
  • 2. clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription
  • 3. viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months
  • 4. current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale \[K10\]) screener)
  • 5. ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol
  • 6. access to cell phone with text messaging capabilities
  • Exclusion Criteria:
  • 1. non-English-speaking
  • 2. cognitive impairments preventing informed consent
  • 3. untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported