An interventional study of Peer Delivery of Medications and Health Information Technology (HIT) Platform in Cardiovascular Disease and Hypertension, sponsored by NYU Langone Health. Recruiting at 3 sites in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research
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.
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.
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This study's planned enrollment of 1,140 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Peer delivery of medications supported by Health Information Technology (HIT) platform.
Other: Peer Delivery of Medications · Other: Health Information Technology (HIT) Platform
Participants in the control arm will receive the standard of care for hypertension or the standard of care including peer-delivery of medication.
Door-to-door peer delivery of medications within patients' communities will be implemented.
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.
Mean Change in SBP from Baseline to Month 12
Time frame: 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.
Time frame: Month 12
Number of Patient E-Signatures
Measure of fidelity.
Time frame: Up to Month 12
Number of Completed HIT Forms
Measure of fidelity.
Time frame: Up to Month 12
Mean Change in SBP from Baseline to Month 6
Time frame: Baseline, Month 6
Percentage of Participants with Controlled Blood Pressure (BP) at Month 6
BP measured using automatic BP monitor.
Time frame: Month 6
Percentage of Participants with Controlled BP at Month 12
BP measured using automatic BP monitor.
Time frame: Month 12
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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