Clinical trial NCT06395207: A Short Period of Proactive Community Case Management (ProCCM) to Improve Early Care-seeking for Fever in Sierra Leone
Official title: A Short Period of Proactive Community Case Management (ProCCM) to Improve Early Care-seeking for Fever in Sierra Leone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Services Research
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Tulane University
name: Sustainable Health Systems Sierra Leone
First posted: 2024-05-02
Enrollment: 9000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Cross sectional collected immediately post-intervention and 5 months post-intervention
Secondary outcomes:
measure: Cost per additional fever case promptly seeking care at qualified provider
timeFrame: 5 months post-intervention
measure: 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
timeFrame: End of the malaria transmission season which will be 2 months post intervention
measure: 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.
timeFrame: End of the malaria transmission season which will be 2 months post intervention
measure: Job satisfaction and perceived workload as described by CHWs during focus groups and interviews
timeFrame: End of the malaria transmission season which will be 2 months post intervention
measure: Differences in touchpoints and connection between CHWs and health facility staff as described through qualitative analysis.
timeFrame: End of the malaria transmission season which will be 2 months post intervention
Other outcomes:
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