Condition category
Infections and Infestations
Date applied
08/07/2015
Date assigned
14/07/2015
Last edited
21/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.asercentre.org/

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)

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26384721

Publication citations

Additional files

Editorial Notes