Evaluation of two communication tools, slideshow and theater, to improve participants' understanding of a clinical trial in the informed consent procedure on Pemba Island, Tanzania.

ABSTRACT:

Background

Clinical trial participants are required to sign an informed consent form (ICF). However, information is lacking on the most effective methods to convey trial relevant information prior to inviting participants to sign the ICF, being particularly pertinent in low-income countries. A previous study on Pemba Island, Tanzania, found that a verbal information session (IS) was significantly better than providing an ICF alone. However, knowledge gaps remained. Building on these findings, we investigated the effect of adding a slideshow or a theater to the IS in the informed consent procedure of an anthelminthic clinical trial.

Methodology/principal findings

A total of 604 caregivers were randomized into the control group that only received an ICF (n = 150) or an ICF plu

SUBMITTER: Palmeirim MS 

PROVIDER: S-EPMC8153490 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature