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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
Study Components and Objectives:
This study will be conducted in two phases:
Study site: This study will be conducted in Tando Muhammad Khan, which is a rural district in the province of Sindh. This would a three and half year study with two year of intervention period.
Study design: This study will follow a mixed methodology approach with a formative research component followed by a prospective two arm cluster randomized controlled trial (cRCT).
Formative Phase: The following activities will be conducted in the formative phase:
Randomized Controlled Trial:
-Randomization: After the mapping and formative research, the clusters (villages) will be randomly allocated to two intervention arms and a control arm by an independent statistician in the ratio of 1:1:1.
Sample size: The sample size was calculated with a power of 0.8 and alpha of 0.05 giving 14 clusters per arm (maximum sample size). These clusters will be randomly allocated to three arms.
Intervention:
Arm 1: In Arm 1, separate male and female village committees (VC) consisting of prominent members of the community including local elites/leaders (6 to 8 in a group) in all the villages will be formed and they would be trained on specific messages regarding the prevention and management of childhood diarrhea and pneumonia. The VCs would carry out awareness and motivational activities for the uptake of the identified interventions. They would also facilitate two hour group meetings to be held twice every month in every village of their catchment area and focus on issues pertaining to childhood nutrition, WASH, vaccines and management of diarrhea and pneumonia in children. Apart from these, there would researcher led awareness sessions in this intervention cluster and specific sessions for children would also be conducted. These sessions would focus on providing education and encourage community participation. Group activities would also identify community level health, nutrition and sanitation problems, and to find locally feasible strategies to address them.
Arm 2: In the second intervention cluster; in addition to the interventions in Arm 1, the areas which improve the practices for preventive and curative strategies for diarrhea and pneumonia will receive community-based incentive. This would be a unique incentive scheme as all the previous financial incentive programs whether conditional or unconditional cash transfers, voucher schemes, social insurance schemes have targeted individuals and all these incentives were based on improving individual practices. The financial incentive proposed is unique as this initiative which would benefit the community as a whole and incentives based on improvement in the composite coverage of three indicators:
Arm 3: This arm will receive routine standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Mobilization | Experimental | 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. |
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| Community Mobilization and Community Incentive | Experimental | 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. |
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| Control | No Intervention | This arm will receive the routine standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Mobilization | Behavioral | Community Mobilization |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Age-appropriate immunization 12-23 months | At six months of intervention | |
| ORS use for diarrhea | At six months of intervention | |
| Mean Sanitation Index | 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:
| At six months of intervention |
| Age-appropriate immunization 12-23 months | At 12 months of intervention | |
| ORS use for diarrhea | At 12 months of intervention | |
| Mean Sanitation Index | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Handwashing with soap at important time | At 24 months of intervention | |
| Exclusive breastfeeding rates - children who are exclusively breastfed at 6 months of age | At 24 months of intervention | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Sindh | 74800 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39706650 | Derived | Das JK, Salam RA, Padhani ZA, Rizvi A, Mirani M, Jamali MK, Chauhadry IA, Sheikh I, Khatoon S, Muhammad K, Bux R, Naqvi A, Shaheen F, Ali R, Muhammad S, Cousens S, Bhutta ZA. An innovative Community Mobilisation and Community Incentivisation for child health in rural Pakistan (CoMIC): a cluster-randomised, controlled trial. Lancet Glob Health. 2025 Jan;13(1):e121-e133. doi: 10.1016/S2214-109X(24)00428-5. | |
| 37192190 |
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The intervention is based on the Behavior Change Theory.
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| Community Mobilization and Community Incentive |
| Behavioral |
Community Mobilization and Community Incentive |
|
| At 12 months of intervention |
| Age-appropriate immunization 12-23 months | At 24 months of intervention |
| ORS use for diarrhea | At 24 months of intervention |
| Mean Sanitation Index | 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:
| At 24 months of intervention |
| Care seeking for severe cases of childhood diarrhea and pneumonia - parents/caregivers who sought care for child with diarrhea/pneumonia |
| At 24 months of intervention |
| Prevalence of Diarrhea and pneumonia | At 24 months of intervention |
| Open defecation rates | At 24 months of intervention |
| Total cost (unit cost and cost effectiveness) | At 24 months of intervention |
| Derived |
| Das JK, Siddiqui F, Padhani ZA, Khan MH, Jabeen S, Mirani M, Mughal S, Baloch S, Sheikh I, Khatoon S, Muhammad K, Gangwani M, Nathani K, Salam RA, Bhutta ZA. Health behaviors and care seeking practices for childhood diarrhea and pneumonia in a rural district of Pakistan: A qualitative study. PLoS One. 2023 May 16;18(5):e0285868. doi: 10.1371/journal.pone.0285868. eCollection 2023. |