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COMPLETED
NCT06387511
NA

Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months

Sponsor: Alliance for International Medical Action

View on ClinicalTrials.gov

Summary

Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services. The investigators will estimate 1) the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, 1) in children aged 12-23 months in the end line cross-sectional household survey, 2) in children aged 6-12 months at inclusion, in a longitudinal 12 months follow-up survey. Secondary objectives are to assess the barriers and facilitators from the perspectives of parents/legal guardian of children, health care providers and community health workers and to assess the cost-efficiency of the This study will be implemented in 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria. This is a pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and end line cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized subsample of health facilities. Clusters will be randomly allocated at a ratio of 1:1 either to the standard arm or to the NutriVax arm: * The standard Expanded Program on Immunization (EPI) in children aged 6-23 months delivered according to the Ministry of Health's routine plans in the community and at health centres and health posts, named the standard EPI arm; * The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm.

Official title: NutriVax-Measles: Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months, a Pragmatic Parallel Cluster-randomized Controlled Trial in Yobe State, Northern Nigeria

Key Details

Gender

All

Age Range

6 Months - 23 Months

Study Type

INTERVENTIONAL

Enrollment

3814

Start Date

2024-05-07

Completion Date

2025-07-30

Last Updated

2026-07-31

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax

1. The SQ-LNS distribution program will be implemented for 12 consecutive months in the NutriVax arm. 2. Community mobilizers in the NutriVax arm will give information in the community about SQ-LNS and eligibility criteria for SQ-LNS distributions. 3. All SQ-LNS distributions will take place at the primary health care center (PHCC) of each ward. 4. Children aged 6-22m, residing in settlements of the catchment area of the NutriVax arm are eligible for a monthly ration of SQ-LNS (28 sachets per month) following a check and update of his or her vaccine status at PHCC; unless there are serious issues related to access to PHCC, in which cases ration sizes may be revised upwards to three months' worth. 5. All children will exit the SQ-LNS distribution program when they are 23 months of age OR after receiving a maximum of 12 consecutive monthly rations, whichever comes first. 6. The total amount of SQ-LNS a child receives will depend on when they enroll in the SQ-LNS distribution program.

BEHAVIORAL

Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices

1. Parents or guardian of children will be encouraged/sensitised to attend their scheduled preventive visits to receive other essential paediatric services; 2. Sensitization on vaccination and recommended Infant and Young Child Feeding (IYCF) practices including the need to consume a diverse nutritious diet and support for continued breastfeeding will be conducted according to the Ministry of Health's routine plans in the community and at primary health care centres; 3. Community mobilizers will promote the importance of vaccinations according to the Expanded Program on Immunization (EPI) as well as IYCF good practices messages.

Locations (1)

All Primary Health Care Centers of Nguru and Karasuwa LGAs

Damaturu, Yobe State, Nigeria