Optimising informed consent for participants in a randomised controlled trial in rural Uganda: a comparative prospective cohort mixed-methods study.

ABSTRACT:

Background

Poor participant understanding of research information can be a problem in community interventional studies with rural African women, whose levels of illiteracy are high. This study aimed to improve the informed consent process for women living in rural eastern Uganda. We assessed the impact of alternative consent models on participants' understanding of clinical trial information and their contribution to the informed consent process in rural Uganda.

Methods

The study applied a parallel mixed-methods design for a prospective comparative cohort, nested within a pilot study on the community distribution of an alcohol-based hand rub to prevent neonatal sepsis (BabyGel pilot trial). Women of at least 34 weeks' pregnancy, suitable for inclusion in the BabyGel pilot tr

SUBMITTER: Ditai J 

PROVIDER: S-EPMC6304001 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature