Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A)
- Conditions
- Cardiovascular DiseaseHypertension
- Interventions
- Other: Peer Delivery of MedicationsOther: Health Information Technology (HIT) Platform
- Registration Number
- NCT06485700
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1140
• Adult participants enrolled in AMPATH's CDM Program with uncontrolled hypertension (SBP ≥ 140 or diastolic BP (DBP) ≥ 90)
- hypertensive emergency requiring immediate medical attention,
- terminal illness, and
- inability to provide informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PT4A Peer Delivery of Medications Peer delivery of medications supported by Health Information Technology (HIT) platform. PT4A Health Information Technology (HIT) Platform Peer delivery of medications supported by Health Information Technology (HIT) platform.
- Primary Outcome Measures
Name Time Method Mean Change in SBP from Baseline to Month 12 Baseline, Month 12 Pill Count Adherence Ratio (PCAR) at Month 12 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 Up to Month 12 Measure of fidelity.
Number of Completed HIT Forms Up to Month 12 Measure of fidelity.
- Secondary Outcome Measures
Name Time Method 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 BP measured using automatic BP monitor.
Percentage of Participants with Controlled BP at Month 12 Month 12 BP measured using automatic BP monitor.
Trial Locations
- Locations (1)
Study Site
🇰🇪Eldoret, Uasin Gishu County, Kenya