Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 1,140
- Locations
- 4
- Primary Endpoint
- Mean Change in SBP from Baseline to Month 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Mean Change in SBP from Baseline to Month 12
Time Frame: Baseline, Month 12
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.
Number of Patient E-Signatures
Time Frame: Up to Month 12
Measure of fidelity.
Number of Completed HIT Forms
Time Frame: Up to Month 12
Measure of fidelity.
Secondary Outcomes
- Mean Change in SBP from Baseline to Month 6(Baseline, Month 6)
- Percentage of Participants with Controlled Blood Pressure (BP) at Month 6(Month 6)
- Percentage of Participants with Controlled BP at Month 12(Month 12)