PT4A (Peers and Technology for Adherence, Access, Accountability, and Analytics) - Modified Project Abstract: PT4A (Peers and Technology for Adherence, Access, Accountability, and Analytics) Medication non-adherence is a major cause of poor hypertension control and adverse CVD outcomes. While numerous evidence-based practices to improve medication adherence are available, there are substantial implementation gaps due to barriers such as medication cost, lack of insurance, medication non-availability, transportation costs, poor patient-clinician relationships, and mistrust of the health system. A synergistic combination of peer-based door-to-door medication delivery and health information technology (HIT) can address implementation gaps and improve adherence to hypertension medications. Peer-based medication delivery decreases the cost of transportation and the opportunity cost of travel and procurement time and can be leveraged to provide psychosocial support and enhance patient activation. HIT can support peer activities by facilitating targeted adherence counseling, teleconsultation, synchronization of clinical care and pharmacy activities, and analytics to improve medication supply. We 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. Since the effectiveness of this implementation strategy is not fully established, our objective is to conduct 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. 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, adherence, and implementation outcomes are one-year change in systolic blood pressure, pill count adherence ratio, and fidelity, respectively. 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. Our results will add to existing knowledge of strategies to improve medication adherence for hypertension control in the U.S. and globally. Our proposal is aligned with the NIH’s goal to advance its mission through a unified strategy. First, we will ensure that the learnings will be applied to U.S. settings. Second, our study team is firmly committed to the goals of reciprocal innovation, and we have been leaders in this field. Third, there are numerous parallels between the study setting and the U.S., reaffirming the importance of lessons learned from this study for U.S. populations. Fourth, our research, training approaches, and cost considerations can support impact in the U.S.
