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

NCT05294510 | Completed

• 2 other identifiers: 18-280315206
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Infections in Children

Keywords

Community health workers; C-reactive protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical Failure (Composite Outcome)

  Between baseline visit and Day 7 follow-up assessment

• Unexpected visits

  Between baseline visit and Day 7 follow-up assessment

• Perceived improvement per caregiver

  Day 7

• Persistent fever

  Day 7

• Development of danger signs

  Between Day 1 and Day 7

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

STAR Sick Child Job Aid OTHER

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.

Intervention

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Bugoye Health Center III

Bugoye, Kasese District, Uganda

Location

Related Publications (1)

• Ciccone EJ, Hu D, Preisser JS, Cassidy CA, Kabugho L, Emmanuel B, Kibaba G, Mwebembezi F, Juliano JJ, Mulogo EM, Boyce RM. Point-of-care C-reactive protein measurement by community health workers safely reduces antimicrobial use among children with respiratory illness in rural Uganda: A stepped wedge cluster randomized trial. PLoS Med. 2024 Aug 19;21(8):e1004416. doi: 10.1371/journal.pmed.1004416. eCollection 2024 Aug.

  PMID: 39159269 DERIVED

Study Officials

• Emily J Ciccone, MD, MHS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: November 2, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: 9 months to 36 months after publication
• 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

Locations

UG (1)