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

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.

Conditions

• Immunization Coverage
• Vaccination
• Nutrition

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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire

  collaborator OTHER

• Yobe State Primary Health Care Board, Nigeria

  collaborator UNKNOWN

• Eleanor Crook Foundation, ECF

  collaborator UNKNOWN

• Gavi, The Vaccine Alliance

  collaborator OTHER

• Alliance for International Medical Action

  lead OTHER

Principal Investigators

• Renaud Becquet, PhD · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

23 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-07

Primary Completion

2025-06-26

Completion

2025-07-30

Countries

• Nigeria

Study Locations