Factors Influencing Pregnant Women's Participation in Randomised Clinical Trials in India: A Qualitative Study.

Abstract

To explore factors affecting participation of pregnant women in randomised clinical trials in Belagavi, Karnataka, India. A qualitative study using semi-structured in-depth interviews and focus group discussions as data collection methods. Primary, secondary and tertiary health facilities and their community catchment areas in Belagavi district. Thirty-three in-depth interviews with health workers and previous participants of a pregnancy-focused trial, and 12 focus group discussions with currently pregnant women who had not previously participated in a clinical trial, family and community members, and accredited social health activists. Inductive thematic analysis with a team-based approach to interpretation in the study context. Pregnant women were often unable to distinguish between maternal health programmes and trial interventions. Among previous trial participants, expectations of higher quality care were a key motivation for trial participation. Household gendered power relations and trust in the health workforce influenced decisional dynamics regarding participation. Health workers vouched for trial safety, once they assessed the intervention as acceptable. Trial Implementation by the health workforce required understanding and navigating pregnancy-related beliefs and practices in communities. Anticipated health benefits, improved healthcare access, and trust in health workers are facilitators of trial participation. Engaging primary decision-makers is essential due to household gender dynamics. Trials must integrate strategies that clarify the distinct goals of research versus clinical care.