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

Publication ,  Journal Article
Corneli, AL; Piwoz, EG; Bentley, ME; Moses, A; Nkhoma, JR; Tohill, BC; Adair, L; Mtimuni, B; Ahmed, Y; Duerr, A; Kazembe, P; van der Horst, C ...
Published in: Contemp Clin Trials
January 2007

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.

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Published In

Contemp Clin Trials

DOI

ISSN

1551-7144

Publication Date

January 2007

Volume

28

Issue

1

Start / End Page

59 / 67

Location

United States

Related Subject Headings

  • Research Design
  • Randomized Controlled Trials as Topic
  • Public Health
  • Patient Compliance
  • Malawi
  • Interviews as Topic
  • Infectious Disease Transmission, Vertical
  • Infant, Newborn
  • Infant
  • Humans
 

Citation

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Corneli, A. L., Piwoz, E. G., Bentley, M. E., Moses, A., Nkhoma, J. R., Tohill, B. C., … UNC Project BAN Study Team, . (2007). Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi. Contemp Clin Trials, 28(1), 59–67. https://doi.org/10.1016/j.cct.2006.08.003
Corneli, Amy L., Ellen G. Piwoz, Margaret E. Bentley, Agnes Moses, Jacqueline R. Nkhoma, Beth Carlton Tohill, Linda Adair, et al. “Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi.Contemp Clin Trials 28, no. 1 (January 2007): 59–67. https://doi.org/10.1016/j.cct.2006.08.003.
Corneli AL, Piwoz EG, Bentley ME, Moses A, Nkhoma JR, Tohill BC, et al. Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi. Contemp Clin Trials. 2007 Jan;28(1):59–67.
Corneli, Amy L., et al. “Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi.Contemp Clin Trials, vol. 28, no. 1, Jan. 2007, pp. 59–67. Pubmed, doi:10.1016/j.cct.2006.08.003.
Corneli AL, Piwoz EG, Bentley ME, Moses A, Nkhoma JR, Tohill BC, Adair L, Mtimuni B, Ahmed Y, Duerr A, Kazembe P, van der Horst C, UNC Project BAN Study Team. Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi. Contemp Clin Trials. 2007 Jan;28(1):59–67.
Journal cover image

Published In

Contemp Clin Trials

DOI

ISSN

1551-7144

Publication Date

January 2007

Volume

28

Issue

1

Start / End Page

59 / 67

Location

United States

Related Subject Headings

  • Research Design
  • Randomized Controlled Trials as Topic
  • Public Health
  • Patient Compliance
  • Malawi
  • Interviews as Topic
  • Infectious Disease Transmission, Vertical
  • Infant, Newborn
  • Infant
  • Humans