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Completed

NCT Number: NCT05051124

Peers and Technology for Adherence, Access, Accountability, and Analytics

The overall objective of this project is to utilize the PRECEDE-PROCEED framework to conduct transdisciplinary, translational implementation research focused on improving medication adherence for hypertension control. The central hypothesis is that peer delivery of medications integrated with HIT (PT4A) will be effective in improving hypertension medication adherence, contributing to improved blood pressure among patients with uncontrolled hypertension in western Kenya. This study record will focus on Sub-Aim 2.2: a pilot of the intervention and a survey questionnaire with patients, peers, and clinical staff to evaluate feasibility. The investigators will evaluate impact on systolic blood pressure, medication adherence, and fidelity of implementation. The investigators will also create a retrospective comparator (control) group of CDM patients, through querying AMRS, matched by sex, age, location and initial blood pressure level. The investigators will then use their recorded blood pressure over a comparable period of up to 1 year and to allow for comparison to the blood pressure changes observed in the patients enrolled in the PT4A program to help understand the magnitude and variance of the intervention effects.

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients ≥ 18 years old
  • Enrolled in the AMPATH CDM PRogram
  • Have uncontrolled hypertension (defined as systolic blood pressures ≥ 140 or diastolic blood pressure ≥ 90)

Exclusion criteria

  • Acute illness requiring immediate medical attention
  • Terminal illness
  • Inability to provide informed consent

Treatment and study plan

Peer Delivery of Medications

Behavioral

The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities

Health Information Technology (HIT) Platform

Behavioral

To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.

Primary outcomes

  1. Absolute Mean Change in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Month 12

  2. Pill Count Adherence Ratio

    Time frame: Month 12

    Proportion of prescribed doses taken over a 1-month time period.

  3. Number of Confirmed Medication Deliveries

    Time frame: Month 12

    Confirmed medication delivery will be documented by patient e-signature.

  4. Number of Peer Completions of HIT Form

    Time frame: Month 12

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

PT4A (Peers and Technology for Adherence, Access, Accountability, and Analytics) - A Qualitative Study

Acronym: PT4A

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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