Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Medication Adherence
• Intervention / Treatment: Behavioral: Peer Delivery of Medications; Behavioral: Health Information Technology (HIT) Platform

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients Enrolled in the AMPATH CDM Program

Behavioral: Peer Delivery of Medications; 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; Behavioral: Health Information Technology (HIT) Platform; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Mean Change in Systolic Blood Pressure (SBP)		Baseline, Month 12
Pill Count Adherence Ratio	Proportion of prescribed doses taken over a 1-month time period.	Month 12
Number of Confirmed Medication Deliveries	Confirmed medication delivery will be documented by patient e-signature.	Month 12
Number of Peer Completions of HIT Form		Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Rajesh Vedanthan, MD, MPH, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 20-01579; 1R56HL150036 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose will have access to the data upon reasonable request. Requests should be directed to rajesh.vedanthan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No