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

NCT06395207 | Not Yet Recruiting

• 1 other identifier: ProCCM V1 2024
• Study Type: interventional
• Target: 9,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.Optimized standard of care- as in arm 1 without ProCCM
3. 3.Routine implementation (control) - no changes (business as usual) to iCCM, SBCC and stock management.

Conditions

Health Services Research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cost per additional fever case promptly seeking care at qualified provider

  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

  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.

  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

  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.

  End of the malaria transmission season which will be 2 months post intervention

Study Arms (3)

Optimized standard of care for CCM plus ProCCM

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

As in arm 1 without ProCCM

Behavioral: Strengthened SBCC and stock out mitigation

Routine implementation (control)

NO INTERVENTION

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

Interventions

Proactive community case management BEHAVIORAL

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.

Optimized standard of care for CCM plus ProCCM

Strengthened SBCC and stock out mitigation BEHAVIORAL

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.

Standard of care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• PATH: lead
• Tulane University: collaborator
• Sustainable Health Systems Sierra Leone: collaborator

Central Study Contacts

Annie Arnzen, MPH

CONTACT

978-806-5837; aarnzen@path.org

Megan Littrell, PhD

CONTACT

mlittrell@path.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 2, 2024
• Study Start: May 6, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share