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Trial · NCT07909395

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryImplementation Fidelity of HEARTS at 12 MonthsMonth 12
Fidelity is defined as the utilization of all components of the HEARTS program: identifying PLWH with uncontrolled hypertension (HTN) and diabetes mellitus (DM); measuring patient anthropometrics and BP; initiating lifestyle counseling and medication treatment every 1-3 months; and referring PLWH with complicated HTN and DM to physicians for further care.
PrimaryChange in Systolic Blood Pressure (SBP) from Baseline to 12 MonthsBaseline, Month 12
PrimaryChange in Hemoglobin A1c (HbA1c) from Baseline to 12 MonthsBaseline, Month 12
SecondarySustainability of HEARTS at 18 MonthsMonth 18Continued utilization of HEARTS components 6 months after completion of the intervention period.
SecondaryBlood Pressure Control at 12 MonthsMonth 12Proportion of study participants with blood pressure (BP) \<140/90 mm Hg at 12 months.
SecondaryBlood Glucose Control at 12 MonthsMonth 12Proportion of study participants with HbA1c \<7% at 12 months.
SecondaryNumber of Sessions with NursesUp to Month 12
SecondaryDuration of Sessions with NursesUp to Month 12
SecondaryNumber of Anthropometric MeasurementsUp to Month 12Total number of measurements obtained.
SecondaryNumber of Lifestyle Counseling SessionsUp to Month 12
SecondaryNumber of Documented ReferralsUp to Month 12

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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