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Childhood DiarrheaCoMICNCT03594279

Community Mobilization and Incentivization for Childhood Diarrhea and Pneumonia

A study testing Community Mobilization and Community Mobilization and Community Incentive in people with Childhood Diarrhea and Childhood Pneumonia, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
Community Mobilization and Community Mobilization and Community Incentive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 sitePakistan
Study dates
1 Jul 2017to 31 Dec 2020
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
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Aga Khan University

    Karachi, Sindh, 74800

Other trials in Pakistan

About this study

Official title: Evaluation of a Community Engagement and Demand Creation Strategy for Childhood Diarrhea and Pneumonia in Pakistan

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.

Read the detailed description

Study Components and Objectives:

This study will be conducted in two phases:

  1. Formative phase: The objective of this phase is to assess the existing care seeking practices and care provision for childhood diarrhea and pneumonia and identify the existing barriers and facilitators for care seeking for childhood diarrhea and pneumonia.
  2. Cluster Randomized Trial: (CoMIC Trial - Community Mobilization and Community Incentivization): The objective of this phase is to assess the impact of a community engagement and demand creation strategy involving an community-based incentive scheme on adherence to recommended preventive and curative practices for diarrhea and pneumonia among children under five years of age.

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:

  • GIS Mapping: for the whole district to map all the government health facilities, schools, major religious places (mosques), water supply sources and roads.
  • Qualitative research: comprising of focus group discussion (FGDs) and in-depth interviews (IDIs) with all stakeholders. These would also identify the potential non-cash incentives that the community wants and could be attractive
  • Baseline Household Survey: Baseline survey will be conducted at the household level and will gather information on health care practices pertaining to childhood diarrhea and pneumonia, immunization, socio-economic indicators, childhood nutrition indicators and WASH indicators. LHWs working in the study area and their geographic spread will also be identified.

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:

  • Age-appropriate immunization 12-23 months
  • ORS use for diarrhea
  • Sanitation index (which is a score based on personal, household and environmental hygiene) The incentives would include 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. The total cost of these incentives would be shared by the project (75%) and the community (25%), to improve ownership. The contribution from the community could also be in-kind including labor etc.

Arm 3: This arm will receive routine standard of care.

Being tested
Community Mobilization, Community Mobilization and Community Incentive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community MobilizationBehavioural

    Community Mobilization

  • Community Mobilization and Community IncentiveBehavioural

    Community Mobilization and Community Incentive

Study groups in NCT03594279
Study groupRoleWhat they receive
Community MobilizationExperimentalThis 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.
Receives: Behavioral: Community Mobilization; Behavioral: Community Mobilization and Community Incentive
Community Mobilization and Community IncentiveExperimentalIn 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.
Receives: Behavioral: Community Mobilization and Community Incentive
ControlNo interventionThis arm will receive the routine standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age-appropriate immunization 12-23 months

    Measured: At six months of intervention

  2. ORS use for diarrhea

    Measured: At six months of intervention

  3. 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:

    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
    1. Food - possible score of minimum 0 and maximum 3
    • Clean dishes are covered;
    • Clean dishes are kept high;
    • All food is covered
    1. 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

    Measured: At six months of intervention

  4. Age-appropriate immunization 12-23 months

    Measured: At 12 months of intervention

  5. ORS use for diarrhea

    Measured: At 12 months of intervention

  6. 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:

    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
    1. Food - possible score of minimum 0 and maximum 3
    • Clean dishes are covered;
    • Clean dishes are kept high;
    • All food is covered
    1. 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

    Measured: At 12 months of intervention

  7. Age-appropriate immunization 12-23 months

    Measured: At 24 months of intervention

  8. ORS use for diarrhea

    Measured: At 24 months of intervention

  9. 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:

    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
    1. Food - possible score of minimum 0 and maximum 3
    • Clean dishes are covered;
    • Clean dishes are kept high;
    • All food is covered
    1. 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

    Measured: At 24 months of intervention

Secondary outcomes (6)

  1. Handwashing with soap at important time

    Measured: At 24 months of intervention

  2. Exclusive breastfeeding rates - children who are exclusively breastfed at 6 months of age

    Measured: 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

    Measured: At 24 months of intervention

  4. Prevalence of Diarrhea and pneumonia

    Measured: At 24 months of intervention

  5. Open defecation rates

    Measured: At 24 months of intervention

  6. Total cost (unit cost and cost effectiveness)

    Measured: At 24 months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2018
  2. Study start1 Jul 2017
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention is based on the Behavior Change Theory.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03594279
Sponsor's protocol ID
4676-WCH-ERC-17
Acronym
CoMIC
Status last verified
Aug 2021
First submitted
28 Jun 2018
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Das JK, Salam RA, Padhani ZA, Rizvi A, Khatoon S, Mirani M, Ahmed I, Bux R, Shaheen F, Muhammad S, Cousens S, Bhutta ZA. Sustainability and adherence to behaviour change: a cross-sectional 3-year follow-up survey of an innovative Community Mobilisation and Community Incentivisation strategy (CoMIC trial) for child health in rural Pakistan. Lancet Glob Health. 2026 Aug 13:104019. doi: 10.1016/j.langlo.2026.104019. Online ahead of print.

    PubMed 42594931

  • 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.

    PubMed 39706650

  • 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.

    PubMed 37192190

Questions about this trial

What is this clinical trial studying?

A study testing Community Mobilization and Community Mobilization and Community Incentive in people with Childhood Diarrhea and Childhood Pneumonia, run by Aga Khan University at 1 site in Pakistan.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age-appropriate immunization 12-23 months (time frame: At six months of intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03594279, which also lists 3 linked publications.

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 31 Aug 2021.

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