Clinical trial NCT06387511: Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immunization Coverage
Vaccination
Nutrition
Keywords: Vaccination coverage
Incentives
Small quantity of Lipid Based Nutrients (SQ-LNS)
Measles
Cost-effectiveness
Acceptability
Child
Africa
Nigeria
Malnutrition, prevention
Lead sponsor: Alliance for International Medical Action
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
name: Yobe State Ministry of Health, Nigeria
name: Eleanor Crook Foundation, ECF
name: Gavi, The Vaccine Alliance
First posted: 2024-04-29
Enrollment: 3720
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two arms opened pragmatic parallel cluster-randomized controlled trial with baseline measure
Primary purpose: PREVENTION

Brief 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)

Eligibility criteria: * Baseline and endline cross-sectional household surveys Inclusion criteria

  * Aged 12-23 months;
  * With oral informed consent of parent or legal guardian;
  * Residing in the catchment settlements of wards included in the study. Exclusion criteria
  * Included in the longitudinal follow-up.
* Longitudinal follow-up survey Inclusion criteria

  * Aged 6-12 months;
  * With written informed consent of parent or legal guardian;
  * Residing in the catchment settlements of wards included in the study. Exclusion criteria
  * Acute malnutrition criteria as per the WHO definition (i.e. MUAC\< 125 or WHZ \< -2 or nutritional edema);
  * - Known medical complication that requires referral for hospitalization;
  * Known allergies to SQ-LNS or SQ-LNS contraindication;
  * Any other condition interfering with protocol adherence or the ability to give informed consent, in the judgment of the Field Investigator Sampling for HHS and LS will be carried out in three stages in each LGA using probability proportional to size (PPS).
* Qualitative feasibility and acceptability survey Inclusion

  * Parent or legal guardian of a child aged 6-23 months and residing in the catchment settlements of wards included in the study, or Health worker of the ministry of health involved in the study,or Community representative or Community health workers;
  * With written informed consent.

Primary outcomes:
measure: Measles vaccine coverage in children aged 12-23 months
timeFrame: Measured after one year after of intervention implementation.
measure: Measles vaccine coverage in children 6-12 months at inclusion
timeFrame: Measured after one year after of intervention implementation.
Secondary outcomes:
measure: Measles vaccine coverage: at least one dose
timeFrame: Measured after one year after of intervention implementation.
measure: Measles vaccine coverage : two doses
timeFrame: Measured after one year after of intervention implementation.
measure: Timeliness of measles 1 vaccination
timeFrame: Measured after one year after of intervention implementation.
measure: Other infant vaccines coverage
timeFrame: Measured after one year after of intervention implementation.
measure: Zero-dose
timeFrame: Measured after one year after of intervention implementation.
measure: Fully immunization
timeFrame: Measured after one year after of intervention implementation.
measure: Acceptability
timeFrame: Measured after 2 months and one year after of intervention implementation.
measure: Cost-efficiency
timeFrame: Measured after one year after of intervention implementation.
Other outcomes:
Locations:
city: Damaturu
country: Nigeria
facility: All Primary Health Care Centers of Nguru and Karasuwa LGAs
state: Yobe
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Renaud Becquet, PhD
role: PRINCIPAL_INVESTIGATOR
References: