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NCT Number: NCT06485700

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

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Study Site, Webuye, Bungoma County, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer Delivery of Medications

Other

Door-to-door peer delivery of medications within patients' communities will be implemented.

Health Information Technology (HIT) Platform

Other

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.

Primary outcomes

  1. Mean Change in SBP from Baseline to Month 12

    Time frame: Baseline, Month 12

  2. Pill Count Adherence Ratio (PCAR) at Month 12

    Time frame: Month 12

    PCAR is calculated as the percentage of pills taken over the previous month and is measured over a 30-day time period.

  3. Number of Patient E-Signatures

    Time frame: Up to Month 12

    Measure of fidelity.

  4. Number of Completed HIT Forms

    Time frame: Up to Month 12

    Measure of fidelity.

Secondary outcomes

  1. Mean Change in SBP from Baseline to Month 6

    Time frame: Baseline, Month 6

  2. Percentage of Participants with Controlled Blood Pressure (BP) at Month 6

    Time frame: Month 6

    BP measured using automatic BP monitor.

  3. Percentage of Participants with Controlled BP at Month 12

    Time frame: Month 12

    BP measured using automatic BP monitor.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Gjonaj

CONTACT

[email protected]

1-646-501-3663

Rajesh Vedanthan

CONTACT

[email protected]

1-646-501-3890

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Acronym: PT4A

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 3, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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