AWaRe1 – WS3 Trial

Workstream Title

The AWaRe1 pragmatic cluster-randomised trial, economic and process evaluation of a WHO AWaRe system based antibiotic stewardship intervention for acute respiratory infections in primary healthcare in low- and middle- income countries (AWaRe1 – WS3 Trial)

Trial Design

Pragmatic parallel arm multi-country cluster randomised superiority trial of an AWaRe-based educational intervention (AWaRe1 – WS2 Education)

Participant Population

The intervention is aimed at prescribers in the clinics. Outcomes will be measured by collection of data from eligible patients presenting to primary healthcare facilities with acute respiratory tract infection symptoms

Eligibility Criteria:

Inclusion:

  • Male or female adult or child aged over 1 year attending a primary healthcare facility with symptoms of acute respiratory illness:
    • Cough with or without fever
    • Chest symptoms (sputum, wheezing).
    • Ear, nose, sinus, or throat symptoms
      • Rhinitis (nasal discharge or blocked nose)
      • Sore throat
      • Ear pain
      • Facial pain

Exclusion:

  • Respiratory symptoms have persisted for more than 14 days
  • Undifferentiated fever (without any respiratory symptoms)
  • Referred from another primary healthcare facility for management of the same problem
Planned Sample Size

8640

Follow up duration

Baseline assessment + intervention training +
12 months of follow up from start of intervention

Planned Study Period

April 2025 – September 2028

Research Aims

Primary outcomes

To estimate the effect of the intervention on receipt of, or prescription for, any antibiotic treatment six months after start of intervention.

Outcome Measures:

Receipt of, or prescription for, any antibiotic during facility visit (measured at exit interview six months after intervention began)

Secondary outcomes

  • To estimate the effect of the intervention on secondary outcomes:
  • To estimate the cost and cost-effectiveness of the intervention
  • To understand the process of intervention delivery and its effects

Outcome Measures:

  • Receipt of, or prescription for, any antibiotic 12 months after start of intervention
  • Category of antibiotic received (Access or Watch or both)
  • Receipt or purchase of any additional antibiotic after the facility visit
  • Respiratory symptoms and health-related quality of life after the facility visit
  • Healthcare utilisation, hospitalisation, and healthcare costs

WS3 Team Leads

Professor Max Bachmann
(Co-Chief Investigator WS3)
Norwich Medical School
University of East Anglia (UEA)
🇬🇧 United Kingdom