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

NYU Langone Health

Status: Not yet enrolling

Conditions: Hypertension; Cardiovascular Disease

Treatments: Other: Health Information Technology (HIT) Platform; Other: Peer Delivery of Medications

Study type: Interventional

Funder types: Other

Identifiers

NCT06485700

24-00277

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,140 participants in 2 patient groups

PT4A

Experimental group

Description:

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

Treatment:

Other: Peer Delivery of Medications

Other: Health Information Technology (HIT) Platform

Control

No Intervention group

Description:

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