Plain English Summary
Background and study aims
We conducted a pilot study of participatory learning and community engagement interventions to improve vaccination coverage in children under 24 months of age in rural Uttar Pradesh, India. The study was designed to assess feasibility and improve methods for a future study of these interventions.
Who can participate?
Women living in 12 villages in rural Uttar Pradesh who were mothers of a child 0 to 23 months of age.
What does the study involve?
Villages were randomly allocated to either the intervention group or the control group. Over 4 months, the intervention group villages received home visits by volunteers and community mobilization events to promote immunization. The control group villages received community mobilization to promote nutrition. A toll-free number for immunization was offered to residents in both groups.
What are the possible benefits and risks of participating?
Possible benefits include increased knowledge about child health (immunization and nutrition). We anticipated no specific risks to participation in the study.
Where is the study run from?
Pratham Education Foundation - ASER Centre (India).
When is the study starting and how long is it expected to run for?
January 2014 to June 2014.
Who is funding the study?
The Bill & Melinda Gates Foundation, the Canadian Institutes for Health Research and the Shastri Indo-Canadian Institute.
Who is the main contact?
Dr Mira Johri
mira.johri@umontreal.ca
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mira Johri
ORCID ID
http://orcid.org/0000-0001-5642-787X
Contact details
Centre de Recherche du Centre Hospitalier de l’Universite de Montreal (CRCHUM)
Tour Saint-Antoine
Porte S03-458
850
rue St-Denis
Montreal
H2X 0A9
Canada
+1 (0)514 343 7318
mira.johri@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Participatory learning and community mobilization interventions versus usual care to increase immunization coverage among children 12-23 months of age in India: pilot study for a cluster randomized trial
Acronym
Study hypothesis
We hypothesized that delivery of participatory learning and community mobilization interventions to increase immunization coverage among children 12-23 months of age in India would be feasible.
Ethics approval
1. Pratham Ethics Committee, B 4/54, Safdarjang Enclave, New Delhi, India, 10/12/2013
2. Research Ethics Committee of the University of Montreal Hospital Research Centre (CRCHUM), CE 12.391, 10/04/2013; updated 10/12/2013
Study design
Single-center intervention feasibility study using a cluster-randomized design
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet.
Condition
Vaccine-preventable diseases in children (tuberculosis, polio, diphtheria, pertussis, tetanus, Hepatitis B, measles)
Intervention
Clusters were assigned to the intervention group (IG) or the control group (CG) using a computer-generated randomization schedule. Neither participants nor those delivering interventions were blinded, but those assessing outcomes were blinded to group assignment.
Over 4 months, IG villages received:
1. Home visits by volunteers
2. Community mobilization events to promote immunization
CG villages received community mobilization to promote nutrition.
A toll-free number for immunization was offered to all IG and CG village residents.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Primary outcomes were ex-ante criteria for feasibility of the main study related to processes for recruitment and randomization (50% of villages would agree to participate and accept randomization; 30 women could be recruited in 70% of villages) and retention of participants (50% of women retained from baseline to end line).
Secondary outcome measures
We studied process indicators related to implementation fidelity and two indicators of community response. We also studied three proxy indicators of intervention impact on immunization uptake. We described differences between IG and CG villages for two cluster-level outcomes:
1. Use of the toll-free number
2. Monthly immunization day footfall
3. We compared performance of IG versus CG participants on the change from baseline to end line survey on key knowledge and awareness indicators.
Overall trial start date
12/01/2014
Overall trial end date
30/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult (18 years of age or older) females living in a study site who are mothers of a child 0-23 months of age
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
We sought to enroll 12 clusters and 36 participants per cluster, for a total of 432 participants allocated equally between intervention and control arms
Participant exclusion criteria
Unable to speak Hindi or Urdu
Recruitment start date
12/01/2014
Recruitment end date
03/02/2014
Locations
Countries of recruitment
India
Trial participating centre
Pratham Education Foundation - ASER Centre
B 4/54, Safdarjang Enclave
New Delhi
110029
India
Sponsor information
Organisation
Centre de Recherche du Centre Hospitalier de l’Universite de Montreal (CRCHUM)
Sponsor details
850
rue St-Denis
Montreal
H2X0A9
Canada
+1 (0)514 890 8000
info.cr.chum@ssss.gouv.qc.ca
Sponsor type
Hospital/treatment centre
Website
http://crchum.chumontreal.qc.ca/
Organisation
Pratham Education Foundation - ASER Centre
Sponsor details
B 4/54
Safdarjang Enclave
New Delhi
110029
India
+91 (0)114 602 3612
contact@asercentre.org
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Bill and Melinda Gates Foundation
Alternative name(s)
Bill & Melinda Gates Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Funder name
Shastri Indo-Canadian Institute
Alternative name(s)
Shastri Institute, SICI
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Canada
Results and Publications
Publication and dissemination plan
We intend to publish the results of this trial in a high-impact peer-reviewed scientific journal.
Intention to publish date
01/08/2015
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26384721