Authors
Meehan, S-A. Hesseling, A.C. Viljoen, L. Cranmer, L.M. Verkuijl, S. Viney, K. Maktabi, M. Isaacs, M. Hirsch-Moverman, Y.
Abstract
METHODS
Using a mixed-methods approach, we conducted: a review of recent, current, and planned trials’ inclusion and exclusion practices, and in-depth interviews with trialists and sponsors.
RESULTS
Of 40 TB therapeutic trials, 7/40 (18%) included PLW; 3/40 (8%) excluded PLW at enrolment but allowed women to remain on study treatment if they became pregnant. None of 12 vaccine trials included PLW but 6/12 (50%) included PLW in safety and/or immunogenicity assessments during study follow-up. Eighteen participants completed in-depth interviews. We identified four broad themes: shifting the narrative, differentiated risks, perceived concerns of PLW, and strategies for inclusion.
