Involving communities in the design of clinical trial protocols: The BAN Study in Lilongwe, Malawi

• Published in: Contemporary clinical trials Vol. 28; no. 1; pp. 59 - 67
• Main Authors: Corneli, Amy L, Piwoz, Ellen G, Bentley, Margaret E, Moses, Agnes, Nkhoma, Jacqueline R, Tohill, Beth Carlton, Adair, Linda, Mtimuni, Beatrice, Ahmed, Yusuf, Duerr, Ann, Kazembe, Peter, van der Horst, Charles
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.01.2007; Elsevier
• Subjects: Adult; Africa; Anti-Retroviral Agents - therapeutic use; Biological and medical sciences; Breast Feeding; Cardiovascular; Clinical trial; Clinical trial. Drug monitoring; Community Participation - methods; Dietary Supplements; Ethics; Female; General pharmacology; Health Knowledge, Attitudes, Practice; Hematology, Oncology and Palliative Medicine; HIV; HIV Infections - drug therapy; HIV Infections - prevention & control; HIV Infections - psychology; HIV Infections - transmission; Human viral diseases; Humans; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunopathology; Infant; Infant, Newborn; Infectious Disease Transmission, Vertical - prevention & control; Infectious diseases; Interviews as Topic; Malawi; Medical sciences; Patient Compliance; Pharmacology. Drug treatments; Qualitative research; Randomized Controlled Trials as Topic - methods; Research Design; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Malawi; Africa; Qualitative research; Ethics; Clinical trial; HIV; Africa; Human; Immunopathology; Antiretroviral agent; Local community; Retroviridae; AIDS; Breast feeding; Immune deficiency; Lentivirus; Feeding; Infection; Virus; Design; Treatment; Viral disease; Antiviral; Human immunodeficiency virus
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2006.08.003

Abstract 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.