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: Recruiting NA study of HIV and Cardiovascular Diseases, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study
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 |
What NCT06001814 shows while recruiting
NCT06001814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Where NCT06001814's enrollment target sits among peer trials
50 219th of 303 higher than 73 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
- NCT01746836 · 50 participants · Phase 2
Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI