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

NCT ID: NCT06485700

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2028-12-31

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.

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.

Conditions

Cardiovascular Disease; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PT4A

Peer delivery of medications supported by Health Information Technology (HIT) platform.

Group Type: EXPERIMENTAL

Peer Delivery of Medications

Intervention Type: OTHER

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

Health Information Technology (HIT) Platform

Intervention Type: 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.

Control

Participants in the control arm will receive the standard of care for hypertension or the standard of care including peer-delivery of medication.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peer Delivery of Medications

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajesh Vedanthan

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Study Site

Webuye, Bungoma County, Kenya

Study Site

Kitale, Trans Nzoia County, Kenya

Study Site

Eldoret, Uasin Gishu County, Kenya

Countries

Kenya

Central Contacts

Rajesh Vedanthan

Role: CONTACT

Rajesh.vedanthan@nyulangone.org

1-646-501-3890

Jessica Gjonaj

Role: CONTACT

Jessica.gjonaj@nyulangone.org

1-646-501-3663

Other Identifiers

24-00277

Identifier Type: -

Identifier Source: org_study_id