Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06001814 · ClinicalTrials.gov registry record · NA
Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
A NA study of HIV and Cardiovascular Diseases, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06001814 is a NA study of HIV and Cardiovascular Diseases that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06001814, a NA study of HIV and Cardiovascular Diseases, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Education
- BEHAVIORAL One-Mind One-Heart
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-07-21 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06001814
The ClinicalTrials.gov registry entry for NCT06001814 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (89% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Education is the first listed.
NCT06001814 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06001814 about?
NCT06001814 is a clinical study titled "Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV". 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 dri...
What is the current status of trial NCT06001814?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2025-07-21. Estimated completion is 2028-08-31.
What conditions does trial NCT06001814 study?
This clinical trial studies the following conditions: HIV, Cardiovascular Diseases.
What interventions are being tested in trial NCT06001814?
The interventions under investigation include: Education (OTHER), One-Mind One-Heart (BEHAVIORAL).
Who is sponsoring clinical trial NCT06001814?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06001814 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Text Education About Cardiovascular Health and HIV (TEACH-HIV)
RECRUITING · NA
-
1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV
RECRUITING · NA
-
Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama
RECRUITING · NA
-
ACCESS: Accelerating Cervical Cancer Elimination Through the Integration of Screen-and-treat Services
RECRUITING · NA
-
Assessing Peer Support for Physical Activity in Women With HIV and Hypertension
RECRUITING · NA
-
Open Trial of Trauma-focused Psychodynamic Psychotherapy for People Living With HIV and PTSD
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.