Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
PT4A
1 other identifier
interventional
1,140
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedStudy Start
First participant enrolled
November 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 20, 2028
February 27, 2026
February 1, 2026
2.4 years
June 27, 2024
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
Mean Change in SBP from Baseline to Month 6
Baseline, Month 6
Percentage of Participants with Controlled Blood Pressure (BP) at Month 6
Month 6
Percentage of Participants with Controlled BP at Month 12
Month 12
Study Arms (2)
PT4A
EXPERIMENTALPeer delivery of medications supported by Health Information Technology (HIT) platform.
Control
NO INTERVENTIONParticipants in the control arm will receive the standard of care for hypertension or the standard of care including peer-delivery of medication.
Interventions
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.
Door-to-door peer delivery of medications within patients' communities will be implemented.
Eligibility Criteria
You may qualify if:
- Adult participants enrolled in AMPATH's CDM Program with uncontrolled hypertension (SBP ≥ 140 or diastolic BP (DBP) ≥ 90)
You may not qualify if:
- hypertensive emergency requiring immediate medical attention,
- terminal illness, and
- inability to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Study Site
Webuye, Bungoma County, Kenya
Study Site
Kitale, Trans Nzoia County, Kenya
Study Site
Eldoret, Uasin Gishu County, Kenya
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajesh Vedanthan
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 3, 2024
Study Start
November 18, 2025
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
April 20, 2028
Last Updated
February 27, 2026
Record last verified: 2026-02
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
- 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.
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.