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Title: Involving communities in the design of clinical trial protocols: The BAN study in Lilongwe, Malawi.
Author: Coneli, A., Piwoz, E., Bentley, M., Moses, A., Nkhoma, J., Adair, L., Mtimuni, B., Ahmed, Y., Duerr, A., Kazembe, P., van der Horst, C. & the UNC Project BAN study
Date Published: 2007
Reference: Contemporary Clinical Trials, 28(1), 59-67.
Are service users or carers authors: Yes

Abstract:

Aim: To learn about the attitudes and concerns of the local community in Lilongwe, Malawi on participating in a clinical trial. The trial aimed to test antiretroviral and nutritional interventions to reduce postnatal transmission of HIV.    

Methods: The views of local community members were obtained by semi-structured interviews, focus group discussions, home observations and taste trials.    

Findings:
The researchers changed their trial protocol so that it would be acceptable to the local community at the same time as achieving its scientific objectives. Without this prior consultation of the community, the researchers conclude that several significant areas would have been undetected which could have jeopardised the trial. Additional research was carried out to develop a meaningful consent process.

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Related entry: none currently available

Categories: health
public health
Designing research
impact on research
impact on research ethics
impact of public involvement
journal article

Date Entered: 2010/09/28

Date Edited: 2012/11/21

Additional Info: