Community-based follow-up of participants of a mother-friendly clinical trial: A patient-centric methodology for pregnant women.

Repeated visits to clinical trial sites inflict hardships on study participants, especially pregnant women. A newer trend is community-based follow-up for measurements, dosage, or monitoring, through technology or physical visits. We conducted a methodological experiment of performing "community-based physical follow-up" of participants of a trial, receiving facility-based diagnosis and pathogen-specific antibiotics for asymptomatic bacteriuria, guided by an optical-sensor-based rapid point-of-care test. We were able to retain 95.8% participants in the study. Here we describe challenges faced and socio-economic and gender issues encountered in this approach in a low-resource Indian scenario, to guide researchers world-wide for designing mother-friendly clinical trials.