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

NCT05051124 | Completed Results

• 2 other identifiers: 20-015791R56HL150036
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Medication Adherence

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Patients Enrolled in the AMPATH CDM Program

EXPERIMENTAL

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

Interventions

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

Patients Enrolled in the AMPATH CDM Program

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.

Patients Enrolled in the AMPATH CDM Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jessica Gjonaj
• Organization: NYU Langone Health

Jessica.gjonaj@nyulangone.org

646-501-3663

Study Officials

• Rajesh Vedanthan, MD, MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: April 19, 2022
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)