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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16703097

Enrollment

432

Registered

2015-07-14

Start date

2014-01-12

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine-preventable diseases in children (tuberculosis, polio, diphtheria, pertussis, tetanus, Hepatitis B, measles) Infections and Infestations

Interventions

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,

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Unable to speak Hindi or Urdu

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026