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Community Mobilization and Incentivization for Childhood Diarrhea and Pneumonia (CoMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594279
Recruitment Status : Active, not recruiting
First Posted : July 20, 2018
Last Update Posted : March 5, 2020
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Dr Jai Kumar Das, Aga Khan University

Brief Summary:
Childhood diarrhea and pneumonia remains the leading cause of mortality among children under five years of age in Pakistan. The prevalence of diarrhea in Pakistan has increased from 15% in 1990 to 23% in 2013 while there has been no progress in the prevalence of pneumonia and it has been almost constant over the last two decades. The coverage of preventive and therapeutic interventions for childhood diarrhea and pneumonia also remains low. This study aims to improve the adherence to recommended preventive and curative practices for childhood diarrhea and pneumonia.

Condition or disease Intervention/treatment Phase
Childhood Diarrhea Childhood Pneumonia Community Mobilisation Sanitation and Hygiene Community Incentives Behavioral: Community Mobilization Behavioral: Community Mobilization and Community Incentive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention is based on the Behavior Change Theory.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Community Engagement and Demand Creation Strategy for Childhood Diarrhea and Pneumonia in Pakistan
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Pneumonia

Arm Intervention/treatment
Experimental: Community Mobilization
This arm will receive specific messages regarding the prevention and management of childhood diarrhea and pneumonia. The investigators will form village committees (VC) consisting of prominent members of the community (6-8 in a group) to carry out awareness and motivational activities for the uptake of the identified interventions.
Behavioral: Community Mobilization
Community Mobilization

Behavioral: Community Mobilization and Community Incentive
Community Mobilization and Community Incentive

Experimental: Community Mobilization and Community Incentive
In this arm, along with the interventions in the community mobilization arm, community based incentives will also be provided. The clusters which improve the practices for preventive and curative strategies for diarrhea and pneumonia will receive community-based incentive including structural benefits linked to health including tube wells, water supply, toilets in community/schools, water storage facility or any other incentive as decided with the respective village committees.
Behavioral: Community Mobilization and Community Incentive
Community Mobilization and Community Incentive

No Intervention: Control
This arm will receive the routine standard of care.



Primary Outcome Measures :
  1. Age-appropriate immunization 12-23 months [ Time Frame: At six months of intervention ]
  2. ORS use for diarrhea [ Time Frame: At six months of intervention ]
  3. Mean Sanitation Index [ Time Frame: At six months of intervention ]

    The scale is focused on 12 components. All the components are valued equally and can be scored '0' (for 'No') or '1' (for 'Yes'). These would be summed up for each household for a total possible score of 12 and a range of 0-12. Higher score represents a better outcome. It comprises of the following three subscales:

    1. Drinking water - possible score of minimum 0 and maximum 3

      • Interior water storage container is covered;
      • Exterior water storage container is cleaned;
      • Water present in water storage container
    2. Food - possible score of minimum 0 and maximum 3

      • Clean dishes are covered;
      • Clean dishes are kept high;
      • All food is covered
    3. Domestic hygiene - possible score of minimum 0 and maximum 6

      • No trash outside the house;
      • No trash inside the house;
      • No unrestrained animals in patio or house;
      • No accumulation of dirty clothes;
      • Insignificant number of flies in house;
      • No standing water in patio or around house

  4. Age-appropriate immunization 12-23 months [ Time Frame: At 12 months of intervention ]
  5. ORS use for diarrhea [ Time Frame: At 12 months of intervention ]
  6. Mean Sanitation Index [ Time Frame: At 12 months of intervention ]

    The scale is focused on 12 components. All the components are valued equally and can be scored '0' (for 'No') or '1' (for 'Yes'). These would be summed up for each household for a total possible score of 12 and a range of 0-12. Higher score represents a better outcome. It comprises of the following three subscales:

    1. Drinking water - possible score of minimum 0 and maximum 3

      • Interior water storage container is covered;
      • Exterior water storage container is cleaned;
      • Water present in water storage container
    2. Food - possible score of minimum 0 and maximum 3

      • Clean dishes are covered;
      • Clean dishes are kept high;
      • All food is covered
    3. Domestic hygiene - possible score of minimum 0 and maximum 6

      • No trash outside the house;
      • No trash inside the house;
      • No unrestrained animals in patio or house;
      • No accumulation of dirty clothes;
      • Insignificant number of flies in house;
      • No standing water in patio or around house

  7. Age-appropriate immunization 12-23 months [ Time Frame: At 24 months of intervention ]
  8. ORS use for diarrhea [ Time Frame: At 24 months of intervention ]
  9. Mean Sanitation Index [ Time Frame: At 24 months of intervention ]

    The scale is focused on 12 components. All the components are valued equally and can be scored '0' (for 'No') or '1' (for 'Yes'). These would be summed up for each household for a total possible score of 12 and a range of 0-12. Higher score represents a better outcome. It comprises of the following three subscales:

    1. Drinking water - possible score of minimum 0 and maximum 3

      • Interior water storage container is covered;
      • Exterior water storage container is cleaned;
      • Water present in water storage container
    2. Food - possible score of minimum 0 and maximum 3

      • Clean dishes are covered;
      • Clean dishes are kept high;
      • All food is covered
    3. Domestic hygiene - possible score of minimum 0 and maximum 6

      • No trash outside the house;
      • No trash inside the house;
      • No unrestrained animals in patio or house;
      • No accumulation of dirty clothes;
      • Insignificant number of flies in house;
      • No standing water in patio or around house


Secondary Outcome Measures :
  1. Handwashing with soap at important time [ Time Frame: At 24 months of intervention ]
  2. Exclusive breastfeeding rates - children who are exclusively breastfed at 6 months of age [ Time Frame: At 24 months of intervention ]
  3. Care seeking for severe cases of childhood diarrhea and pneumonia - parents/caregivers who sought care for child with diarrhea/pneumonia [ Time Frame: At 24 months of intervention ]
  4. Prevalence of Diarrhea and pneumonia [ Time Frame: At 24 months of intervention ]
  5. Open defecation rates [ Time Frame: At 24 months of intervention ]
  6. Total cost (unit cost and cost effectiveness) [ Time Frame: At 24 months of intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • People residing in the villages in the selected study site and consent to participate.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594279


Locations
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Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Bill and Melinda Gates Foundation

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Responsible Party: Dr Jai Kumar Das, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03594279    
Other Study ID Numbers: 4676-WCH-ERC-17
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Diarrhea
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms