A study of trial participants' understanding and attitudes towards randomisation, double-blinding and placebo use, and a pilot intervention in a microbicide trial in Malawi.

Abstract

This empirical study was aimed at assessing trial participants’ understanding of randomisation, double blinding and placebo use as well as investigating their attitudes towards the three procedures. The study was conducted within the HPTN035 microbicide trial that was being conducted in Blantyre and Lilongwe in Malawi among other sites. The study was descriptive in nature and used a combination of qualitative and quantitative methods which included review of study documents, in-depth interviews with study staff, structured interviews with a sample of 203 participants and two focus group discussions with 18 microbicide trial participants. Overall, more than half of participants were categorised as having lower levels of understanding on the concepts under study. The study also established that the majority of participants had negative attitudes towards the three procedures. Based on these findings, a pilot intervention was designed aimed at improving understanding. The pilot intervention consisted of an information session which was delivered with the assistance of a PowerPoint. During the session, the three terms were explained using a story based on the growing of crops, as Malawi is an agricultural society. The intervention phase was delivered using a sample of 36 low scorers who were randomly assigned to the intervention and non-intervention arms. An assessment after the intervention suggested that the intervention was useful in improving understanding of the three procedures. The findings provide some evidence that research participants can understand research procedures if the procedures are explained in user-friendly terms and if information concerning their justification and personal implications is provided. The findings further suggest that the intervention was useful in changing participants’ attitudes towards randomisation and double blinding. The intervention did not change attitudes towards placebo use in a statistically significant way. Theoretical and practical recommendations, as well as suggestions for further research were recommended.