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

Peer-based medication delivery decreases the cost of transportation and the opportunity cost of travel while HIT can support peer activities by facilitating targeted adherence counseling, teleconsultation, synchronization of clinical care, and pharmacy activities. The investigators have implemented a pilot program of door-to-door peer-based medication delivery and HIT in western Kenya, and preliminary data indicate improved adherence and blood pressure. However, the effectiveness of this implementation strategy is not fully established. Therefore, the objective of the study is to use the PRECEDE-PROCEED framework to conduct transdisciplinary implementation research to test the hypothesis that integrating peer delivery of medications with HIT (PT4A) improves medication adherence and reduces blood pressure among patients with uncontrolled hypertension in western Kenya.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Cardiovascular Disease
• Intervention / Treatment: Other: Peer Delivery of Medications; Other: Health Information Technology (HIT) Platform

Detailed Description

Aim 1 will evaluate the effectiveness of PT4A by conducting a two-arm cluster randomized controlled implementation research hybrid type 2 trial, comparing PT4A to control. The primary biological outcome is one-year change in systolic blood pressure. The primary adherence outcome is the pill count adherence ratio. The primary implementation outcome is fidelity. Secondary outcomes are blood pressure control, self-reported adherence, and RE-AIM metrics. Aim 2 will evaluate potential mechanistic relationships between implementation measures and outcomes. Sub Aim 2.1 will evaluate if trust in the health system and patient activation mediate the relationship between PT4A and the outcomes. Aim 3 will consist of cost-effectiveness, budget impact, and qualitative analyses to help inform adaptation of PT4A to other settings. The research will be conducted by a transdisciplinary team with diverse and complementary expertise. The investigators intend to add to existing knowledge of innovative and scalable strategies to improve medication adherence for global hypertension control.

• Study Type: Interventional
• Enrollment (Estimated): 1140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rajesh Vedanthan; Phone Number: 1-646-501-3890; Email: Rajesh.vedanthan@nyulangone.org
• Study Contact Backup: Name: Jessica Gjonaj; Phone Number: 1-646-501-3663; Email: Jessica.gjonaj@nyulangone.org

Study Locations

• Kenya
  • Bungoma County
    • Webuye, Bungoma County, Kenya
      • Recruiting
      • Study Site
  • Trans Nzoia County
    • Kitale, Trans Nzoia County, Kenya
      • Recruiting
      • Study Site
  • Uasin Gishu County
    • Eldoret, Uasin Gishu County, Kenya
      • Recruiting
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult participants enrolled in AMPATH's CDM Program with uncontrolled hypertension (SBP ≥ 140 or diastolic BP (DBP) ≥ 90)

Exclusion Criteria:

• hypertensive emergency requiring immediate medical attention,
• terminal illness, and
• inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PT4A; Peer delivery of medications supported by Health Information Technology (HIT) platform.	Other: Peer Delivery of Medications; Door-to-door peer delivery of medications within patients' communities will be implemented.; Other: Health Information Technology (HIT) Platform; The HIT platform provides: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) medication refill tracking to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data.
No Intervention: Control; Participants in the control arm will receive the standard of care for hypertension or the standard of care including peer-delivery of medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in SBP from Baseline to Month 12		Baseline, Month 12
Pill Count Adherence Ratio (PCAR) at Month 12	PCAR is calculated as the percentage of pills taken over the previous month and is measured over a 30-day time period.	Month 12
Number of Patient E-Signatures	Measure of fidelity.	Up to Month 12
Number of Completed HIT Forms	Measure of fidelity.	Up to Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in SBP from Baseline to Month 6		Baseline, Month 6
Percentage of Participants with Controlled Blood Pressure (BP) at Month 6	BP measured using automatic BP monitor.	Month 6
Percentage of Participants with Controlled BP at Month 12	BP measured using automatic BP monitor.	Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Rajesh Vedanthan, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): April 20, 2028

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: 24-00277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Rajesh.vedanthan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• 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: The investigator who proposed to use the data will be granted access 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