Using parents and health workers to increase the number of children who received all the recommended childhood vaccinations without any delay in the communities of Ebonyi state, Nigeria

A cluster-randomised controlled trial of hybrid parents and health workers adaptive intervention for optimal routine childhood immunization coverage in the communities of Ebonyi state, Nigeria – The AGINTOPIC Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59811905

Enrollment

720

Registered

2022-06-29

Start date

2022-06-30

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

Vaccine-preventable infectious diseases Infections and Infestations

Interventions

Villages (communities) will be allocated into control and intervention groups in a 1:1 ratio through covariate-constrained randomisation by the principal investigator and an independent statistician.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Clusters: 1. Catchment PHC facilities are providing maternal and child health care services including routine childhood immunization and have weekly immunization clinics or sessions 2. Estimated average number of monthly deliveries is >20 3. Easily accessible or close to a road that is drivable even during the rainy season 4. No similar intervention is ongoing or occurred within the preceding year 5. Are at least 10 km apart or are separated by a buffer area or natural barrier 6. Cluster heads and PHC workers (the officers-in-charge) in the catchment PHC facilities give consent to participate PHC workers: 1. Involved in the provision of routine childhood immunization services in the PHC facilities within the selected clusters 2. Provide consent to participate Parents: 1. Parents (mothers, fathers, primary caregivers, or guardians) of infants aged between 0 and 2 months within the selected clusters 2. Permanent and regular residents of the clusters 3. Do not plan to migrate within the next year 4. Provide consent to participate Household members: 1. Children aged between 5 and 23 months 2. Mother or primary caregivers who give provides consent to participate

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. The optimal or timely (cumulative age-appropriate) receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 5–9 completed months and 10–11 completed months measured using population-based household surveys at baseline and 11 month follow-up 2. The age-appropriate vaccines receipt score for the recommended vaccines in the routine childhood immunization schedule by children aged 5–9 completed months and 10–11 completed months measured using population-based household surveys at baseline and 11 months	—

Measure

Time frame

1. The optimal or timely (cumulative age-appropriate) receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 5–9 completed months and 10–11 completed months measured using population-based household surveys at baseline and 11 month follow-up 2. The age-appropriate vaccines receipt score for the recommended vaccines in the routine childhood immunization schedule by children aged 5–9 completed months and 10–11 completed months measured using population-based household surveys at baseline and 11 months

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Secondary

Measure	Time frame
1. The up-to-date receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 5–9 completed months and 10–11 completed months measured using population-based household surveys at baseline and 11 months 2. The dropout rate between Penta-1 and Penta-3 among children aged 5–9 completed months and 10–11 completed months measured using population-based household surveys at baseline and 11 months 3. The optimal or timely receipt of vitamin A-1, receipt of vitamin A-1, and vitamin A-1 receipt score among children aged 10–11 completed months measured using population-based household surveys at baseline and 11 months 4. The up-to-date receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months 5. The (12 months) age-appropriate receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months 6. The optimal or timely (cumulative age-appropriate) receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months 7. The age-appropriate vaccines receipt score for the recommended vaccines in the routine childhood immunization schedule by children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months 8. The dropout rate between Penta-1 and Penta-3 among the children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months	—

Measure

Time frame

1. The up-to-date receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 5–9 completed months and 10–11 completed months measured using population-based household surveys at baseline and 11 months 2. The dropout rate between Penta-1 and Penta-3 among children aged 5–9 completed months and 10–11 completed months measured using population-based household surveys at baseline and 11 months 3. The optimal or timely receipt of vitamin A-1, receipt of vitamin A-1, and vitamin A-1 receipt score among children aged 10–11 completed months measured using population-based household surveys at baseline and 11 months 4. The up-to-date receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months 5. The (12 months) age-appropriate receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months 6. The optimal or timely (cumulative age-appropriate) receipt of the recommended vaccines in the routine childhood immunization schedule by children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months 7. The age-appropriate vaccines receipt score for the recommended vaccines in the routine childhood immunization schedule by children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months 8. The dropout rate between Penta-1 and Penta-3 among the children aged 12–23 completed months measured using population-based household surveys at baseline and 11 months

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Countries

Nigeria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026