NCT06001814 Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
| NCT ID | NCT06001814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-07-21 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-07-21 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation. Systemic inflammation is exacerbated by psychological distress via activating the immune response and driving pro-inflammatory CVD risk behaviors. There is promising evidence to suggest that mindfulness could be an effective intervention to reduce psychological distress and support behaviorally- and inflammatory-mediated CVD risk reduction. This project aims to refine and synthesize mindfulness and behavior change content from evidence-based protocols (mindfulness-based stress reduction and diabetes prevention program) to develop and pilot test a new text message-enhanced intervention called "One Mind One Heart" (OM-OH) using feedback from semi-structured interviews with OPWH in psychological distress (N=20), and my multidisciplinary mentorship team (Aim 1). An open pilot (N=5) with exit interviews and pre-post self-report assessments, will inform the initial acceptability of OM-OH and further refine OM-OH as needed (Aim 2). Finally, a pilot randomized controlled trial (RCT; N=50) will be conducted to a.) evaluate benchmarks of feasibility and acceptability of study methods and refined OM-OH compared to enhanced usual care, and b.) investigate potential for effects on psychological distress, inflammation, and behavioral CVD risk (Aim 3). Findings will provide the foundation for an R01 application to conduct an efficacy trial of OM-OH to reduce inflammatory-mediated CVD risk among OPWH.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06001814 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06001814 currently recruiting?
Yes, NCT06001814 is actively recruiting participants. Contact the research team at jdfoley@mgh.harvard.edu for enrollment information.
Where is the NCT06001814 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06001814 clinical trial?
NCT06001814 is sponsored by Massachusetts General Hospital. The trial plans to enroll 50 participants.
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