Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06395207
Other study ID # ProCCM V1 2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 6, 2024
Est. completion date March 30, 2025

Study information

Verified date April 2024
Source PATH
Contact Annie Arnzen, MPH
Phone 978-806-5837
Email aarnzen@path.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 9000
Est. completion date March 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
PATH Sustainable Health Systems Sierra Leone, Tulane University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT00692497 - Electronic Referral and Booking of Outpatient Day Case Surgery Compared With Traditional Referral Routines. N/A
Completed NCT01296906 - Population Versus Practice-based Interventions to Increase Immunizations N/A
Completed NCT02896790 - From the Model to the Adaptation of a Therapeutic Education Program (TEP) in Cancer Research N/A
Completed NCT01074762 - Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus N/A
Recruiting NCT04291534 - Quality of Life and Addiction Among Hospital Night Workers
Completed NCT06341738 - The Efficacy of Digital Educational Interventions on Parental HPV Knowledge and Attitude, and Their Children's Vaccination Rates N/A
Not yet recruiting NCT06408233 - Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State (Project 3) N/A
Completed NCT04118452 - Achieving My Potential: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System N/A
Completed NCT02053467 - Building Capacity for Specialized Services Through eConsultation N/A
Completed NCT03330509 - Effectiveness of the Supportive and Palliative Care Review Kit (SPARK) for Cancer Patients in the Acute Hospital N/A
Not yet recruiting NCT06184724 - Implementation Pilot of Preoperative CGA Before Major Surgery N/A
Completed NCT04837274 - Anderson Study 1 - Tart Cherry Study N/A