Table 1

Summary of challenges encountered by the Expanded Program on Immunization Consortium team with study responses to them

Broad challengesSpecific challengesResponse
Human resource challenge Limited in-country specialists.
  • Regional recruitment from the West-African subregion.

Vaccination policy changeAdministration of birth vaccine doses before discharge to babies delivered in select government hospitals.
  • Speedily addressed bottleneck with government authorities.

Logistic challenges
  • Limited road network.

  • Lack of a functional house address system.

  • Shipping of biosamples to northern collaborators.

  • Worked with the Medical Research Council unit’s logistic and transport system.

Participant recruitment
  • Sensitised participants delivering outside the study location.

  • Competing interest with another study at the research site.

  • Early discharges from labour ward pressures.

  • Commenced recruitment at an additional facility.

  • Set up a roving team.

  • Re-organised staff rota to maximise recruitments.

Host health facility challenges
  • Space constraints.

  • Neonatal sepsis outbreak.

  • Built an office complex for research operations.

  • Capacity building for government staff on infection control and newborn resuscitation.

  • Worked with and provided technical assistance to host health facility to tackle an outbreak.

Rumours and misconceptionsStudy-related rumours.
  • Community sensitisation.

  • Prepared communication strategy to address rumours.

  • ICH-GCP - International Conference on Harmonisation-Good Clinical Practice