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 |
| Protocol serial number | N/A |
| Sponsors | Centre de Recherche du Centre Hospitalier de l’Universite de Montreal (CRCHUM), Pratham Education Foundation - ASER Centre, Centre Hospitalier de l’Université de Montréal |
| Funders | Bill and Melinda Gates Foundation, Canadian Institutes of Health Research, Shastri Indo-Canadian Institute |
- 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
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
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 ID |
0000-0001-5642-787X |
|---|---|
| Phone | +1 (0)514 343 7318 |
| mira.johri@umontreal.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center intervention feasibility study using a cluster-randomized design |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
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: |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 432 |
| Key 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 |
| Key exclusion criteria | Unable to speak Hindi or Urdu |
| Date of first enrolment | 12/01/2014 |
| Date of final enrolment | 03/02/2014 |
Locations
Countries of recruitment
- India
Study participating centre
New Delhi
110029
India
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/09/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
