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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: One-Mind One-Heart for 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 driving pro-inflammatory CVD risk behaviors.

Official registry: https://clinicaltrials.gov/study/NCT06001814 · Massachusetts General Hospital · enrollment listed as 50

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are One-Mind One-Heart, or Education. The registry lists allocation as randomized. Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation.

They plan to enroll about 50 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

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

Interventions: One-Mind One-Heart, Education

Primary outcome (registry wording): Feasibility of recruitment

Who it is for (from inclusion criteria)

  • Ages 50 Years to any
  • clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription
  • viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months
  • current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale \[K10\]) screener)
  • ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol
  • access to cell phone with text messaging capabilities

Public study contact (from the registry)

Jacklyn Foley, PhD

857-347-5312

jdfoley@mgh.harvard.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06001814 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06001814?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06001814?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary