Improving Antibiotic Stewardship for Children With Respiratory Illness Presenting to Village Health Workers in Uganda (STAR)

STewardship for Acute Respiratory Illness (STAR): a Stepped Wedge, Cluster Randomized Trial of Point-of-care Biomarker Testing by Village Health Workers

This is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the Bugoye sub-county of the Kasese District in southwestern Uganda.

The purpose of this study is to assess the impact of the algorithm on antibiotic use.

Study Overview

• Status: Completed
• Conditions: Respiratory Infections in Children
• Intervention / Treatment: Other: STAR Sick Child Job Aid

• Study Type: Interventional
• Enrollment (Actual): 1280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kasese District
    • Bugoye, Kasese District, Uganda
      • Bugoye Health Center III

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 2 months-5 years
• Evaluated by a study VHW in one of the participating villages in Bugoye sub-county for acute respiratory illness defined as the following: fever (documented (temperature > 38°C) or subjective fever in the last seven days) AND fast breathing (respiratory rate > 30) OR cough

Exclusion Criteria:

• Age > 5 years or < 2 months at time of presentation
• Guardian not present to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Children who present to a village health worker during a control period are evaluated and managed using the current standard of care per Uganda National Guidelines for Integrated Community Case Management (ICCM). Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design.
Experimental: Intervention; Children who present to a village health worker during an intervention period are evaluated and managed using a modified ICCM algorithm that includes point-of-care C-reactive protein testing. Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design.	Other: STAR Sick Child Job Aid; The STAR Sick Child Job Aid is a modified ICCM protocol that includes the addition of a point-of-care C-reactive protein (CRP) test to inform antibiotic treatment decisions for children presenting with febrile acute respiratory illness who do not have any danger signs. If CRP ≥ 40 mg/L, the village health worker (VHW) will dispense amoxicillin per local guidelines. If CRP < 40 mg/L, the VHW will advise symptomatic care alone including acetaminophen for fever and additional fluids to maintain hydration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic prescriptions at baseline visit	Proportion of children prescribed antibiotics by the village health worker at the baseline visit in the control as compared to the intervention condition.	Baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Failure (Composite Outcome)	Proportion of children with one or more of the following outcomes in the control as compared to the intervention condition: persistence of fever at Day 7, development of danger signs as defined by local Integrated Community Care Management guidelines at any time during the seven-day follow-up period, need for hospitalization at any time during follow-up period, or death at any time during follow-up period.	Between baseline visit and Day 7 follow-up assessment
Unexpected visits	Proportion of children brought to the village health worker during the seven-day follow-up period for persistent or worsening symptoms by their caregiver in the control as compared to the intervention condition.	Between baseline visit and Day 7 follow-up assessment
Perceived improvement per caregiver	Proportion of caregivers who perceive that their child has clinically improved at the Day 7 follow-up assessment in the control as compared to the intervention condition.	Day 7
Persistent fever	Proportion of children who have persistence of subjective or documented fever at the Day 7 follow-up assessment in the control as compared to the intervention condition.	Day 7
Development of danger signs	Proportion of children who develop danger signs (as defined by local Integrated Community Care Management guidelines) during the seven-day follow-up period in the control as compared to intervention conditions.	Between Day 1 and Day 7
Hospitalization	Proportion of children who require inpatient admission to a health facility during the seven-day follow-up period in the control as compared to intervention periods.	Between Day 1 and Day 7
Death	Proportion of children who die during the seven-day follow-up period in the control as compared to intervention periods.	Between Day 1 and Day 7
Antibiotic prescriptions during study follow-up	Proportion of children prescribed antibiotics by any provider either at the baseline visit or during the seven-day follow-up period in the control as compared to the intervention condition.	Between baseline visit and Day 7 follow-up assessment

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Thrasher Research Fund
• Investigators: Principal Investigator: Emily J Ciccone, MD, MHS, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Community health workers; C-reactive protein
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 18-2803; 15206 (Other Grant/Funding Number: Thrasher Research Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified individual data that underlie the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 months to 36 months after publication
• IPD Sharing Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No