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A cluster-randomised trial of a multifaceted intervention to promote child vaccination and linkage to social protection schemes

A cluster-randomised 12-month, parallel arm, superiority trial of a multifaceted intervention to promote child VaccInation and linKage to sociAl protection Schemes (VIKAS) versus usual services on vaccination uptake among children 12 - 23 months

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15768745
Enrollment
7810
Registered
2024-06-26
Start date
2024-07-15
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Prevention of vaccine-preventable diseases in children Infections and Infestations

Interventions

Current interventions as of 14/10/2024: The VIKAS study is a pragmatically oriented trial, designed to demonstrate the effectiveness of the interventions in real-world conditions. The interventions

Sponsors

Canadian Institutes of Health Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Communities: 1.1. Located in a catchment area of a health sub-centre assigned to the intervention group, 1.2. Designated as possible "missed community" (low immunisation area), and 1.3. Consent is received from community gatekeepers (local elected officials with territorial responsibility, such as the Pradhan (mayor)). 2. All adult (>18 years of age) participants in communities selected to receive the intervention will be eligible to participate 3. All frontline health workers in the intervention group with territorial responsibility for a community selected to receive the interventions will be included in the field interventions. 4. Participants in the baseline and end line cross-sectional household surveys are primary caregivers (usually mothers) and other adult (over age 18 years ) family members of immunisation-age (0 to 23 months) children. Participants are eligible for inclusion in the household surveys if they reside in a study cluster (rural health sub-centre) catchment area and in an immunisation microplan area designated as a possible low immunisation area, and provide written informed consent. We will exclude those not able to understand and speak Hindi or Urdu.

Exclusion criteria

Exclusion criteria: 1. Participation in Interventions: None. 2. Participation in data collection: We will exclude those not able to understand and speak Hindi or Urdu. Based on our experience, in this district, this criterion would result in exclusion of less than 1% of respondents.

Design outcomes

Primary

MeasureTime frame
The mean number (count) of government-recommended first year of life vaccine doses received by children 12 to 23 months of age at study end line measured using patient records

Secondary

MeasureTime frame
1. The (binary) proportion of vaccine received at study end line for children 12 to 23 months measured using patient records 2. The (binary) proportion of age-appropriate vaccine received at study end line, for children 0 to 11 months measured using patient records

Countries

India

Contacts

Public ContactMira Johri
mira.johri@umontreal.ca+1 514 343-7318

Outcome results

None listed

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