Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Proactive Community Case Management and Child Survival: A Cluster-Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate whether the addition of Proactive Case Detection to Community Case Management will provide an increase in early access to health care and a reduction in deaths among children aged 0-59 months. Integrated Community Case Management is the package of community-based services for children delivered by Community Health Workers (CHW), including diagnosis and treatment of malaria, pneumonia, diarrheal disease and malnutrition. In many iCCM interventions, CHWs are stationed in their villages and available in a passive, reactive manner to provide care to patients who seek them out. This study seeks to determine whether the addition of proactive case detection by CHWs to a standard iCCM intervention (ProCCM), in which they conduct daily door-to-door home visits to find and care for patients, will improve early access to care and reduce child mortality.

Village-clusters will be randomised to receive Integrated Community Case Management (iCCM) from a passive CHW or Proactive Community Case Management (ProCCM) from a CHW that conducts daily active case finding home visits. All villages in both study arms will receive additional interventions that could significantly reduce under-five mortality, including removal of point-of-care fees, clinical staff training at primary health centres, and improvement in primary health centre infrastructure.

All women of reproductive age eligible for inclusion in the study will be surveyed at baseline, and again at 12, 24 and 36 months. The study hypothesis is a significant reduction in child mortality in both study arms, with a significantly larger reduction where there is proactive case detection, or ProCCM, by CHWs. A survey of all women enrolled in the three-year study (eligible and consenting) has 82% power to detect an absolute difference in under-five mortality of 0.75% (a relative difference of 25%) between the two study arms.


Options:
A: Arm Label: Current Practice; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention Arm; Type: ACTIVE_COMPARATOR; Interventions: Device: Malaria Rapid Diagnostic test | Intervention Type: DEVICE; Name: Malaria Rapid Diagnostic test; Assigned to Arm(s): Intervention Arm
B: Arm Label: Proactive Community Case Management (ProCCM); Type: EXPERIMENTAL; Interventions: Other: Proactive Community Case Management, Other: Removal of point-of-care user fees, Other: Infrastructure improvements at primary health centre, Other: Training of primary health centre staff | Arm Label: integrated Community Case Management (iCCM); Type: ACTIVE_COMPARATOR; Interventions: Other: Integrated Community Case Management, Other: Removal of point-of-care user fees, Other: Infrastructure improvements at primary health centre, Other: Training of primary health centre staff | Intervention Type: OTHER; Name: Proactive Community Case Management; Assigned to Arm(s): Proactive Community Case Management (ProCCM) | Intervention Type: OTHER; Name: Integrated Community Case Management; Assigned to Arm(s): integrated Community Case Management (iCCM) | Intervention Type: OTHER; Name: Removal of point-of-care user fees; Assigned to Arm(s): Proactive Community Case Management (ProCCM), integrated Community Case Management (iCCM) | Intervention Type: OTHER; Name: Infrastructure improvements at primary health centre; Assigned to Arm(s): Proactive Community Case Management (ProCCM), integrated Community Case Management (iCCM) | Intervention Type: OTHER; Name: Training of primary health centre staff; Assigned to Arm(s): Proactive Community Case Management (ProCCM), integrated Community Case Management (iCCM)
C: Arm Label: ICCM delivered by VHT; Type: ACTIVE_COMPARATOR; Interventions: Other: ICCM delivered by VHT | Arm Label: ICCM delivered by VHT with cell phone; Type: ACTIVE_COMPARATOR; Interventions: Other: ICCM delivered by VHT, Other: ICCM delivered by VHT with Cell Phone | Arm Label: Health outcomes in communities with no ICCM; Type: ACTIVE_COMPARATOR; Interventions: Other: No intervention | Intervention Type: OTHER; Name: ICCM delivered by VHT; Assigned to Arm(s): ICCM delivered by VHT, ICCM delivered by VHT with cell phone | Intervention Type: OTHER; Name: ICCM delivered by VHT with Cell Phone; Assigned to Arm(s): ICCM delivered by VHT with cell phone | Intervention Type: OTHER; Name: No intervention; Assigned to Arm(s): Health outcomes in communities with no ICCM
D: Arm Label: rapid diagnostic test; Type: ACTIVE_COMPARATOR; Interventions: Device: Rapid diagnostic test, Drug: Lumartem | Arm Label: Presumptive malaria treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Rapid diagnostic test; Assigned to Arm(s): rapid diagnostic test | Intervention Type: DRUG; Name: Lumartem; Assigned to Arm(s): rapid diagnostic test

Answer: B