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

Study Overview
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Brief Summary
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The overall objective of this project is to utilize the PRECEDE-PROCEED framework to conduct transdisciplinary, translational implementation research focused on improving medication adherence for hypertension control. The central hypothesis is that peer delivery of medications integrated with HIT (PT4A) will be effective in improving hypertension medication adherence, contributing to improved blood pressure among patients with uncontrolled hypertension in western Kenya. This study record will focus on Sub-Aim 2.2: a pilot of the intervention and a survey questionnaire with patients, peers, and clinical staff to evaluate feasibility. The investigators will evaluate impact on systolic blood pressure, medication adherence, and fidelity of implementation. The investigators will also create a retrospective comparator (control) group of CDM patients, through querying AMRS, matched by sex, age, location and initial blood pressure level. The investigators will then use their recorded blood pressure over a comparable period of up to 1 year and to allow for comparison to the blood pressure changes observed in the patients enrolled in the PT4A program to help understand the magnitude and variance of the intervention effects.

Official Title
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PT4A (Peers and Technology for Adherence, Access, Accountability, and Analytics) - A Qualitative Study

Conditions
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Hypertension, Medication Adherence

Intervention / Treatment
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* Behavioral: Peer Delivery of Medications
* Behavioral: Health Information Technology (HIT) Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ≥ 18 years old Enrolled in the AMPATH CDM PRogram Have uncontrolled hypertension (defined as systolic blood pressures ≥ 140 or diastolic blood pressure ≥ 90) Exclusion Criteria: Acute illness requiring immediate medical attention Terminal illness Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients Enrolled in the AMPATH CDM Program<br> | Behavioral: Peer Delivery of Medications<br>* The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities<br>Behavioral: Health Information Technology (HIT) Platform<br>* To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Mean Change in Systolic Blood Pressure (SBP) |  | Baseline, Month 12 | 
| Pill Count Adherence Ratio | Proportion of prescribed doses taken over a 1-month time period. | Month 12 | 
| Number of Confirmed Medication Deliveries | Confirmed medication delivery will be documented by patient e-signature. | Month 12 | 
| Number of Peer Completions of HIT Form |  | Month 12 |