An interventional study of Proactive community case management and Strengthened SBCC and stock out mitigation in Health Services Research, sponsored by PATH. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by PATH · Not applicable, Interventional, and Health services research
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:
PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
As in arm 1 without ProCCM
Behavioral: Strengthened SBCC and stock out mitigation
No changes (business as usual) to iCCM, SBCC and stock 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.
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.
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.
Time frame: Cross sectional collected immediately post-intervention and 5 months post-intervention
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of the malaria transmission season which will be 2 months post intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2024; primary completion for Mar 2025, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.