A Short Period of Proactive Community Case Management (ProCCM) to Improve Early Care-seeking for Fever in Sierra Leone

This is a three arm cluster randomized control trial to determine if proactive community case management (ProCCM) conducted over a short period of time improves care-seeking indicators for febrile illnesses in children in hard to reach (HTR) areas of Sierra Leone compared to integrated community case management (iCCM). The three arms include:

1. Optimized standard of care for CCM plus ProCCM - ProCCM will be implemented for two months near the start of the transmission season, and the existing program will be supplemented to ensure that HTR CHWs have all commodities needed for malaria testing and treatment and are adequately trained on SBCC messages to ensure activities are implemented as designed.
2. Optimized standard of care- as in arm 1 without ProCCM
3. Routine implementation (control) - no changes (business as usual) to iCCM, SBCC and stock management.

Study Overview

• Status: Not yet recruiting
• Conditions: Health Services Research
• Intervention / Treatment: Behavioral: Proactive community case management; Behavioral: Strengthened SBCC and stock out mitigation

• Study Type: Interventional
• Enrollment (Estimated): 9000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annie Arnzen, MPH; Phone Number: 978-806-5837; Email: aarnzen@path.org
• Study Contact Backup: Name: Megan Littrell, PhD; Email: mlittrell@path.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Household lives within the study cluster
• Head of household or a household member over the age of 18 provides verbal consent for the HTR CHW visit
• All available household members at the time of the HTR CHW visits are eligible to receive services

Exclusion Criteria:

• Household does not live within the study cluster
• Household does not provide consent for the study visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimized standard of care for CCM plus ProCCM; ProCCM will be implemented for two months near the start of the transmission season, and the existing program will be supplemented to ensure that HTR CHWs have all commodities needed for malaria testing and treatment and are adequately trained on SBCC messages to ensure activities are implemented as designed.	Behavioral: Proactive community case management; Community health workers conduct proactive visits to households in their community every two weeks for two months to screen for fever and test and treat febrile individuals for malaria.
Active Comparator: Standard of care; As in arm 1 without ProCCM	Behavioral: Strengthened SBCC and stock out mitigation; Ensure CHWs have all commodities needed for malaria testing and treatment and are adequately trained on SBCC messages to ensure activities are implemented as designed in the national strategy.
No Intervention: Routine implementation (control); No changes (business as usual) to iCCM, SBCC and stock management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of children under five years of age with recent fever (within the past two weeks) who sought care from a CHW or public health facility on the same day or day after fever onset	Changes in care seeking will be assessed through three cross-sectional surveys. A baseline survey will be conducted prior to intervention implementation followed by a second survey at or near the end of the ProCCM intervention period and a final survey at the end of the malaria transmission season.	Cross sectional collected immediately post-intervention and 5 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost per additional fever case promptly seeking care at qualified provider	Using project records and information from the cross-sectional surveys, the cost of delivering ProCCM, incremental SBCC and stockout management interventions will be determined with the incremental number of fever cases receiving prompt management by a qualified provider as the denominator.	5 months post-intervention
Barriers and enablers of care-seeking behavior for febrile illness of people of all ages and how ProCCM impacts this behavior explored through focus groups	Focus group discussions will be held with community members post-intervention to assess barriers and enablers of care-seeking for febrile illness among people of all ages and how ProCCM impacts this behavior as reported by community members	End of the malaria transmission season which will be 2 months post intervention
Perceptions of the availability, cost, quality, and ease of seeking care for febrile illness explored through focus groups and in-depth interviews with community members.	Focus group discussions and in-depth interviews will be held with community members to explore their perception of the intervention and how it impacts their sense of the availability, cost, quality, and ease of seeking care for febrile illness.	End of the malaria transmission season which will be 2 months post intervention
Job satisfaction and perceived workload as described by CHWs during focus groups and interviews	Focus groups and in-depth interviews will be conducted with community health workers to explore their job satisfaction and perceived workload as it relates to the intervention.	End of the malaria transmission season which will be 2 months post intervention
Differences in touchpoints and connection between CHWs and health facility staff as described through qualitative analysis.	In-depth interviews will be conducted with health facility staff and peer supervisors to explore how the intervention influences their perceived linkages and touchpoints with CHWs.	End of the malaria transmission season which will be 2 months post intervention

Collaborators and Investigators

• Sponsor: PATH
• Collaborators: Tulane University; Sustainable Health Systems Sierra Leone

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ProCCM V1 2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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