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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Infections in Children

Intervention / Treatment
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* Other: STAR Sick Child Job Aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped wedge, cluster randomized trial with 5 clusters or treatment sequences of 3 villages each. Villages are first stratified by altitude, proximity to the local health center, and size (based on approximate number of children seen by the village health workers per year) into one of three strata: (1) low altitude, proximal, large, (2) low altitude, mid-distance, medium, (3) high altitude, distal, small. One village is then randomly selected from each strata for each of the 5 clusters. All clusters start in the control condition and one cluster crosses over from control to intervention each month.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community health workers, C-reactive protein