Implementation challenges in a community-based randomized clinical trial in the rural settings of India

Abstract

BACKGROUND: Community-based randomized controlled trials are the benchmark for evaluating public health interventions due to their real-world relevance. However, their implementation, particularly in resource-limited, rural settings, is challenging. This article details our experience in addressing these hurdles during a nutrition intervention study in rural Karnataka, India. METHODS: Our study was a descriptive analysis of the implementation challenges encountered as part of a larger cluster randomized clinical trial among adults with prediabetes residing in rural Karnataka. We analysed challenges encountered during community mobilization, screening, recruitment, data collection, and intervention delivery. A team of six research fellows was rooted in the communities, and a qualitative assurance supervisor conducted weekly field visits to identify and address challenges. In-depth qualitative interviews were conducted with the research fellows, and data were analysed using a thematic content analysis. The study's problem-solving framework was based on agile management principles. RESULTS: We encountered significant challenges related to community mistrust, patriarchal sociocultural barriers, and logistical and operational hurdles. The research team addressed these problems in real time by living within the communities, leveraging the established trust of local health workers, and implementing an agile problem-solving framework. The study's focus on cultural sensitivity and on-the-ground problem-solving was crucial to its high participant retention rate. CONCLUSION: Our findings highlight the critical methodological and ethical challenges inherent in community-based randomized controlled trials and demonstrate that a flexible, adaptive, and culturally sensitive approach is essential for success in similar settings. The innovative, real-time solutions we developed can be a valuable guide for other community-academic partnerships, providing insights that bridge the gap between scientific protocol and real-world implementation. TRIAL REGISTRATION NUMBER: The trial is registered in the clinical trial registry of India (CTRI/2023/03/050421).