Effectiveness of peer-group therapy using community based participatory research model on medication adherence among patients of diabetes and/or hypertension: Study protocol for a multi-centercluster randomized trial in rural settings across India (PARTICIPATE study)

Background : According to the WHO, more than 50% of patients do not take their medications as prescribed. Nonadherence is caused by several variables, such as social and economic factors, issues with the healthcare team and system, problems relating to specific diseases, characteristics of those diseases, and their treatments. Objective : To study the effectiveness of PARTICIPATE intervention at community level regarding medication adherence among diabetes and/or hypertension adults in rural India. Study design : This is a multicenter cluster randomized trial implemented across 04 blocks (64 villages) of 04 districts in East, West, North, and South India, and will cover 2880 randomly selected participants, with a nested economic evaluation to measure the effectiveness of community-based participatory research (CBPR). The intervention will be delivered by peer educators identified from the community for the duration of 12-month with the first 6 months, followed by once monthly for the next 6 months, and the control group continue to receive all aspects of standard care offered by healthcare providers (public or private). Methods : The measure of drug adherence for hypertension and/or diabetes, as determined by the self-reported Morisky Medication Adherence Scale (MMAS-8) at baseline, midterm, and end, is the study's outcome variable. The independent variables, viz., socio-economical and number of antihypertensive and/or antidiabetic drugs and their duration, self-perceived health status, systolic and diastolic blood pressure and/or HbA1c, will becontrolled while doing the analysis. Secondary outcomes include improvement in health literacy using All Aspects of Health Literacy Scale (AAHS), clinical outcomes, quality of life using EURO-QoL (EQ-5D), cost-effectiveness and return on investment (ROI). Process evaluations will be conducted with a sub-sample of participants to examine engagement in various intervention components. The fidelity of intervention will be monitored using the Normalisation Process Theory framework. Discussion : To the best of our knowledge, this is the first multi-centre cluster randomized controlled trial in India to assess the effectiveness of CBPR approach for improving medication adherence among diabetics and hypertensives. The results of this study will contribute to the evidence of scaling-up peer-educator models for diabetes and hypertension management in India and similar low-and middle-income countries. Trial registration : The registration number for this trial is CTRI/2024/01/061939