Health Services ResearchNCT06395207
A Short Period of Proactive Community Case Management (ProCCM) to Improve Early Care-seeking for Fever in Sierra Leone
A study testing Proactive community case management and Strengthened SBCC and stock out mitigation in people with Health Services Research, run by PATH.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Services Research
- What is being tested?
- Proactive community case management and Strengthened SBCC and stock out mitigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Household does not live within the study cluster
- Household does not provide consent for the study visit
Trial locations and contacts
No sites are listed yet.
Megan Littrell, PhD contact
About this study
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:
- 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.
- Optimized standard of care- as in arm 1 without ProCCM
- Routine implementation (control) - no changes (business as usual) to iCCM, SBCC and stock management.
- Conditions
- Health Services Research
- Being tested
- Proactive community case management, Strengthened SBCC and stock out mitigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive community case managementBehavioural
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 mitigationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Proactive community case management |
| Standard of care | Active comparator | As in arm 1 without ProCCM Receives: Behavioral: Strengthened SBCC and stock out mitigation |
| Routine implementation (control) | No intervention | No changes (business as usual) to iCCM, SBCC and stock management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of the malaria transmission season which will be 2 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start6 May 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University, Sustainable Health Systems Sierra Leone
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395207
- Sponsor's protocol ID
- ProCCM V1 2024
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short Period of Proactive Community Case Management (ProCCM) to Improve Early Care-seeking for Fever in Sierra Leone
- ClinicalTrials.gov ID
- NCT06395207
- Acronym / sponsor ID
- ProCCM V1 2024
- Conditions
- Health Services Research
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Tulane University, Sustainable Health Systems Sierra Leone
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Optimized standard of care- as in arm 1 without ProCCM
- Routine implementation (control) - no changes (business as usual) to iCCM, SBCC and stock management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Optimized standard of care for CCM plus ProCCM | Experimental | Behavioral: Proactive community case managementProCCM 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. |
| Standard of care | Active comparator | Behavioral: Strengthened SBCC and stock out mitigationAs in arm 1 without ProCCM |
| Routine implementation (control) | No intervention | –No changes (business as usual) to iCCM, SBCC and stock management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Household does not live within the study cluster
- Household does not provide consent for the study visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive community case managementCommunity 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. | Behavioural | Optimized standard of care for CCM plus ProCCM |
| Strengthened SBCC and stock out mitigationEnsure 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. | Behavioural | Standard of care |
Primary outcome
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
Time frame: Cross sectional collected immediately post-intervention and 5 months post-intervention
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.
5 secondary outcomes
Cost per additional fever case promptly seeking care at qualified provider
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
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.
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
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.
Time frame: End of the malaria transmission season which will be 2 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Littrell, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Proactive community case management and Strengthened SBCC and stock out mitigation in people with Health Services Research, run by PATH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie Arnzen, MPH (978-806-5837, aarnzen@path.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Cross sectional collected immediately post-intervention and 5 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.