Paul Ndebele|Douglas Wassenaar|Esther Munalula|Francis Masiye
Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi
HJF Medical Research International|University of KwaZulu-Natal|University of Zambia|University of Malawi
intervention reported paper follow empirical study conducted malawi aim assessing trial participants understanding randomisation doubleblinding placebo use empirical study majority respondents 611 n124 obtained low scores lower 75 understanding three concepts study based findings intervention based narrative included three concepts personal implications designed narrative used daily examples field agriculture malawi agrobased economythe intervention tested using sample 36 women identified low scorers empirical study 36 low scorers randomly assigned control n18 intervention arms n18 control arm went session provided standard informed consent information microbicide trial intervention arm went session provided narrative chichewa local language assistance power point presentation included pictures well discussions justification personal implications concepts studythe findings efficacy intervention suggest 3 scientific concepts personal implications understood low literacy populations using simple language everyday local examples findings also suggest intervention positively impacted understanding trial procedures study 13 18 women intervention arm obtained high scores 75 post intervention assessment none 18 control arm obtained high score using fischers exact test confirmed effect intervention understanding three procedures statistically significant p00001potential trial participants assisted understand key clinical trial procedures justification personal implications using innovative tailored local narratives