NCT06387511

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,814 (actual)
• Sponsor: Alliance for International Medical Action · Academic / Other
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Accepted

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.

Detailed description

Background/ Rational Every year, hundreds of thousands of children are treated for severe wasting while experiencing repeated and prolonged outbreaks of vaccine-preventable illnesses, most notably measles. At least 20 million children annually still do not receive immunizations. Northeast Nigeria is at the epicentre of this dynamic, recording some of the worst malnutrition indicators and lowest vaccination coverage rates in the world. Small-quantity lipid-based nutrient supplements (SQ-LNS) are a class of ready-to-use food supplements which are highly nutrient-dense and fortified designed for preventing malnutrition and improving child survival, growth, and development. A recent meta-analysis on SQ-LNS reveals that feeding a child just one sachet of SQ-LNS a day for a year can reduce their risk of mortality by 27%, and reduce cases of severe wasting by 31% and severe stunting by 17%. The overall strength of evidence on SQ-LNS benefits led the authors of a 2021 Lancet review to call scaling-up SQ-LNS a priority action. Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services. Primary objective To estimate 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, in children aged 12-23 months in the end line cross-sectional household survey. Main secondary objective To estimate 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, in children aged 6-12 months at inclusion in the longitudinal 12 months follow-up survey. Secondary objectives * To estimate the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in children aged 6-23 months, after 12 months of program implementation, in terms of 1) all other infant vaccines' uptake, 2) timeliness of age-eligible vaccinations; 3) anthropometric status, 4) uptake of paediatric curative and preventive health consultations and activities. * To assess the barriers and facilitators to SQ-LNS mass supplementation implemented as part of a routine immunization program in health facilities, from the perspectives of parents/legal guardian of children aged 6-23 months, health care providers and community health workers. * To assess the cost-efficiency of a SQ-LNS mass supplementation program compared to routine immunization program in terms of cost per child supplemented and vaccinated. Study sites : 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria Study design 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. Interventions compared 1. 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. 2. 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. The unit of randomization (cluster) will be the ward and its catchment area. Clusters will be randomly allocated at a ratio of 1:1 either to the standard EPI arm or to the NutriVax arm. Statistical analyses Differences in measles vaccine coverage (dose 1) between control and intervention arms at end line will be assessed using multilevel regression models. The study will be conducted in compliance with the protocol, the Declaration of Helsinki, the GCP guidelines and the Nigerian National Code for Health Research Ethics Timeline : 2 years (December 2023-December 2025)

Conditions

• Immunization Coverage
• Vaccination
• Nutrition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-07
• Primary completion: 2025-06-26
• Completion: 2025-07-30
• First posted: 2024-04-29
• Last updated: 2026-03-10

Locations

1 site across 1 country: Nigeria