Engagement of the community, traditional leaders, and public health system in the design and implementation of a large community-based, cluster-randomized trial of umbilical cord care in Zambia

Am J Trop Med Hyg. 2015 Mar;92(3):666-72. doi: 10.4269/ajtmh.14-0218. Epub 2015 Feb 2.


Conducting research in areas with diverse cultures requires attention to community sensitization and involvement. The process of community engagement is described for a large community-based, cluster-randomized, controlled trial comparing daily 4% chlorhexidine umbilical cord wash to dry cord care for neonatal mortality prevention in Southern Province, Zambia. Study preparations required baseline formative ethnographic research, substantial community sensitization, and engagement with three levels of stakeholders, each necessitating different strategies. Cluster-specific birth notification systems developed with traditional leadership and community members using community-selected data collectors resulted in a post-natal home visit within 48 hours of birth in 96% of births. Of 39,679 pregnant women enrolled (93% of the target of 42,570), only 3.7% were lost to follow-up or withdrew antenatally; 0.2% live-born neonates were lost by day 28 of follow-up. Conducting this trial in close collaboration with traditional, administrative, political, and community stakeholders facilitated excellent study participation, despite structural and sociocultural challenges.

Trial registration: ClinicalTrials.gov NCT01241318.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Infective Agents, Local / administration & dosage
  • Anti-Infective Agents, Local / therapeutic use*
  • Bacterial Infections / prevention & control*
  • Chlorhexidine / administration & dosage
  • Chlorhexidine / therapeutic use*
  • Community Participation
  • Female
  • Humans
  • Infant, Newborn
  • Postpartum Period
  • Pregnancy
  • Public Health Administration
  • Umbilical Cord*
  • Zambia / epidemiology


  • Anti-Infective Agents, Local
  • Chlorhexidine

Associated data

  • ClinicalTrials.gov/NCT01241318