Pilot study for a cluster randomized trial of community engagement interventions to increase immunization coverage among children 12-23 months of age in India

ISRCTN ISRCTN16703097
DOI https://doi.org/10.1186/ISRCTN16703097
Secondary identifying numbers N/A
Submission date
08/07/2015
Registration date
14/07/2015
Last edited
21/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Mira Johri
Scientific

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

ORCiD logoORCID ID 0000-0001-5642-787X
Phone +1 (0)514 343 7318
Email mira.johri@umontreal.ca

Study information

Study designSingle-center intervention feasibility study using a cluster-randomized design
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet.
Scientific titleParticipatory 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
Study objectivesWe 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(s)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
Health condition(s) or problem(s) studiedVaccine-preventable diseases in children (tuberculosis, polio, diphtheria, pertussis, tetanus, Hepatitis B, measles)
InterventionClusters 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 typeBehavioural
Primary outcome measurePrimary 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 measuresWe 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 study start date12/01/2014
Completion date30/06/2014

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsWe sought to enroll 12 clusters and 36 participants per cluster, for a total of 432 participants allocated equally between intervention and control arms
Key inclusion criteriaAdult (18 years of age or older) females living in a study site who are mothers of a child 0-23 months of age
Key exclusion criteriaUnable to speak Hindi or Urdu
Date of first enrolment12/01/2014
Date of final enrolment03/02/2014

Locations

Countries of recruitment

  • India

Study participating centre

Pratham Education Foundation - ASER Centre
B 4/54, Safdarjang Enclave
New Delhi
110029
India

Sponsor information

Centre de Recherche du Centre Hospitalier de l’Universite de Montreal (CRCHUM)
Hospital/treatment centre

850, rue St-Denis
Montreal
H2X0A9
Canada

Phone +1 (0)514 890 8000
Email info.cr.chum@ssss.gouv.qc.ca
Website http://crchum.chumontreal.qc.ca/
Pratham Education Foundation - ASER Centre
Charity

B 4/54, Safdarjang Enclave
New Delhi
110029
India

Phone +91 (0)114 602 3612
Email contact@asercentre.org
Website http://www.asercentre.org/
Centre Hospitalier de l’Université de Montréal
Not defined

Funders

Funder type

Charity

Bill and Melinda Gates Foundation
Government organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
Location
United States of America
Canadian Institutes of Health Research
Government organisation / National government
Alternative name(s)
Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location
Canada
Shastri Indo-Canadian Institute
Government organisation / Universities (academic only)
Alternative name(s)
Shastri Institute, indo-canadien Shastri Institut, Institut indo-canadien Shastri, शास्त्री इंस्टीट्यूट, शास्त्री भारत-कनाडाई संस्थान, Shastri Indo Canadian Institute, SICI
Location
India

Results and Publications

Intention to publish date01/08/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe intend to publish the results of this trial in a high-impact peer-reviewed scientific journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/09/2015 Yes No