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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Involving communities in the design of clinical trial protocols: The BAN Study in Lilongwe, Malawi
Contemporary Clinical Trials, Volume 28, No. 1, Year 2007
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Description
Objective: To learn the attitudes and concerns of the local community on participating in research, infant feeding practices, and maternal nutrition in order to inform the design of a clinical trial in Lilongwe, Malawi on the safety and efficacy of antiretroviral and nutrition interventions to reduce postnatal transmission of HIV. Design: Formative research methods were used, including semi-structured interviews, focus group discussions, home observations, and taste trials. Data were collected, analyzed, and incorporated into the protocol within 3 months. Results: Participants were supportive of the clinical trial, although their overall understanding of research was limited. Mothers agreed that infants' blood could be drawn by venipuncture, yet concern was raised about the amount of blood proposed to be collected from both infants and mothers. Data demonstrated that rapid breastfeeding cessation would be difficult and malnutrition could be a risk if infants were weaned early. Mothers selected a maternal supplement suitable for use in the clinical trial. Conclusions: The protocol was rapidly modified to achieve cultural acceptability while maintaining study objectives. Without the formative research, several significant areas would have been undetected and may have jeopardized the implementation of the trial. Additional research was carried out to develop a meaningful informed consent process, the amount of blood collected was reduced to acceptable levels, and the protocol was modified to reduce the risk of malnutrition. Researchers who conduct clinical trials are encouraged to incorporate formative research into their protocol design to ensure participant understanding of the research, to safeguard participants, and to increase feasibility and acceptance of the clinical research in the community. © 2006 Elsevier Inc. All rights reserved.
Authors & Co-Authors
Corneli, Amy L.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Piwoz, Ellen G.
United States, Durham
Fhi 360
Bentley, Margaret E.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Moses, Agnes
Malawi, Lilongwe
Unc Project-malawi
Nkhoma, Jacqueline R.
Malawi, Lilongwe
Unc Project-malawi
Tohill, Beth Carlton
United States, Atlanta
Centers for Disease Control and Prevention
Adair, Linda S.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Mtimuni, Beatrice M.
Malawi, Lilongwe
Lilongwe University of Agriculture and Natural Resources
Ahmed, Yusuf I.
United States, Atlanta
Centers for Disease Control and Prevention
Duerr, Ann C.
United States, Atlanta
Centers for Disease Control and Prevention
Kazembe, Peter N.
Malawi, Lilongwe
Kamuzu Central Hospital
van der Horst, Charles Michael
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Statistics
Citations: 42
Authors: 12
Affiliations: 6
Identifiers
Doi:
10.1016/j.cct.2006.08.003
ISSN:
15517144
Research Areas
Food Security
Infectious Diseases
Maternal And Child Health
Study Design
Exploratory Study
Study Approach
Qualitative
Study Locations
Malawi