title: Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi.
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.
  
  
  METHODS
  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.
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. acorneli@fhi.org
authors.forename: Amy L
authors.initials: AL
authors.lastname: Corneli
authors.forename: Ellen G
authors.initials: EG
authors.lastname: Piwoz
authors.forename: Margaret E
authors.initials: ME
authors.lastname: Bentley
authors.forename: Agnes
authors.initials: A
authors.lastname: Moses
authors.forename: Jacqueline R
authors.initials: JR
authors.lastname: Nkhoma
authors.forename: Beth Carlton
authors.initials: BC
authors.lastname: Tohill
authors.forename: Linda
authors.initials: L
authors.lastname: Adair
authors.forename: Beatrice
authors.initials: B
authors.lastname: Mtimuni
authors.forename: Yusuf
authors.initials: Y
authors.lastname: Ahmed
authors.forename: Ann
authors.initials: A
authors.lastname: Duerr
authors.forename: Peter
authors.initials: P
authors.lastname: Kazembe
authors.forename: Charles
authors.initials: C
authors.lastname: van der Horst
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D001942:Breast Feeding; D003256:Community Participation / Q000379:methods*; D019587:Dietary Supplements; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control* / Q000523:psychology / Q000635:transmission*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007407:Interviews as Topic; D008295:Malawi; D010349:Patient Compliance; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design
chemical_list: D044966:Anti-Retroviral Agents