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

PATH

Status: Not yet enrolling

Conditions: Health Services Research

Treatments: Behavioral: Strengthened SBCC and stock out mitigation; Behavioral: Proactive community case management

Study type: Interventional

Funder types: Other

Identifiers

NCT06395207

ProCCM V1 2024

Details and patient eligibility

About

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.

Enrollment: 9,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,000 participants in 3 patient groups

Optimized standard of care for CCM plus ProCCM

Experimental group

Description:

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.

Treatment:

Behavioral: Proactive community case management

Standard of care

Active Comparator group

Description:

As in arm 1 without ProCCM

Treatment:

Behavioral: Strengthened SBCC and stock out mitigation

Routine implementation (control)

No Intervention group

Description:

No changes (business as usual) to iCCM, SBCC and stock management.