Aga Khan University
Karachi, Sindh, 74800, Pakistan
NCT Number: NCT03594279
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Karachi, Sindh, 74800, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Community Mobilization
Community Mobilization and Community Incentive
Time frame: At six months of intervention
Time frame: At six months of intervention
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:
Time frame: At 12 months of intervention
Time frame: At 12 months of intervention
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:
Time frame: At 24 months of intervention
Time frame: At 24 months of intervention
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:
Time frame: At 24 months of intervention
Time frame: At 24 months of intervention
Time frame: At 24 months of intervention
Time frame: At 24 months of intervention
Time frame: At 24 months of intervention
Time frame: At 24 months of intervention
Aga Khan University
Other
Evaluation of a Community Engagement and Demand Creation Strategy for Childhood Diarrhea and Pneumonia in Pakistan
Acronym: CoMIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07331311
Childhood Pneumonia, Infections
Bhaktapur, Bagmati, Nepal
View Trial DetailsNCT06951347
Childhood Pneumonia
Cairo, Egypt
View Trial DetailsNCT04495361
Acute Respiratory Infection, Childhood Pneumonia
Islamabad, Federal, Pakistan
View Trial DetailsNCT03784274
Childhood Pneumonia, Infections
Islamabad, Federal, Pakistan
View Trial Details