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

Not Applicable

Completed

• Conditions: Hypertension; Medication Adherence
• Interventions: Behavioral: Peer Delivery of Medications; Behavioral: Health Information Technology (HIT) Platform

• Registration Number: NCT05051124
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Study Start: 2022-04-19
• Primary Completion: 2024-01-25
• Study Completion: 2024-01-25
• Results First Submitted: 2025-01-24
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Results First Posted: 2025-03-19
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients Enrolled in the AMPATH CDM Program	Health Information Technology (HIT) Platform	-
Patients Enrolled in the AMPATH CDM Program	Peer Delivery of Medications	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States