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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT05294510
• Collaborator: Thrasher Research Fund (Other)
• Enrollment: 1,280
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 186.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Infections in Children	Other: STAR Sick Child Job Aid	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1280 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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)
• Primary Purpose: Diagnostic
• Official Title: STewardship for Acute Respiratory Illness (STAR): a Stepped Wedge, Cluster Randomized Trial of Point-of-care Biomarker Testing by Village Health Workers
• Actual Study Start Date: Nov 2, 2021
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: May 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Antibiotic prescriptions at baseline visit [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.

Secondary Outcome Measures

1. Clinical Failure (Composite Outcome) [Between baseline visit and Day 7 follow-up assessment]

   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.

2. Unexpected visits [Between baseline visit and Day 7 follow-up assessment]

   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.

3. Perceived improvement per caregiver [Day 7]

   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.

4. Persistent fever [Day 7]

   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.

5. Development of danger signs [Between Day 1 and Day 7]

   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.

6. Hospitalization [Between Day 1 and Day 7]

   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.

7. Death [Between Day 1 and Day 7]

   Proportion of children who die during the seven-day follow-up period in the control as compared to intervention periods.

8. Antibiotic prescriptions during study follow-up [Between baseline visit and Day 7 follow-up assessment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. OR cough

Exclusion Criteria:

• Age > 5 years or < 2 months at time of presentation

• Guardian not present to provide consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bugoye Health Center III	Bugoye	Kasese District	Uganda

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• Thrasher Research Fund

Investigators

• Principal Investigator: Emily J Ciccone, MD, MHS, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT05294510
• Other Study ID Numbers: 18-2803; 15206
• First Posted: Mar 24, 2022
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of North Carolina, Chapel Hill: Community health workers; C-reactive protein
• Additional relevant MeSH terms: Respiratory Tract Infections

Study Results

No Results Posted as of Aug 4, 2022