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

NCT06387511 | Completed DMC

• 1 other identifier: NutriVax-Measles
• Study Type: interventional
• Target: 3,814
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Measles vaccine coverage in children aged 12-23 months

  The proportion of children aged 12-23 months in the endline survey who have received at least one dose of measles vaccine, as reported on their vaccination card.

  Measured after one year after of intervention implementation.

• Measles vaccine coverage in children 6-12 months at inclusion

  The proportion of children aged 6-12 months at inclusion in the longitudinal follow-up survey, who have received at least one additional dose of measles vaccine, as reported on their vaccination card, administered between inclusion and the end of follow-up.

  Measured after one year after of intervention implementation.

Secondary Outcomes (8)

• Measles vaccine coverage: at least one dose

  Measured after one year after of intervention implementation.

• Measles vaccine coverage : two doses

  Measured after one year after of intervention implementation.

• Timeliness of measles 1 vaccination

  Measured after one year after of intervention implementation.

• Other infant vaccines coverage

  Measured after one year after of intervention implementation.

• Zero-dose

  Measured after one year after of intervention implementation.

Study Arms (2)

Standard Expanded program on immunization

ACTIVE COMPARATOR

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.

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

NutriVax

EXPERIMENTAL

The NutriVax strategy combines the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres for children 6-23 months of age.

Dietary Supplement: Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax; Behavioral: Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices

Interventions

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

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.

NutriVax

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

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.

NutriVax; Standard Expanded program on immunization

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 12-23 months;
• With oral informed consent of parent or legal guardian;

You may not qualify if:

• Included in the longitudinal follow-up.
• Aged 6-12 months;
• With written informed consent of parent or legal guardian;
• 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).
• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire: collaborator
• Yobe State Primary Health Care Board, Nigeria: collaborator
• Eleanor Crook Foundation, ECF: collaborator
• Gavi, The Vaccine Alliance: collaborator
• Alliance for International Medical Action: lead

Study Sites (1)

All Primary Health Care Centers of Nguru and Karasuwa LGAs

Damaturu, Yobe State, Nigeria

Location

Related Publications (1)

• Cazes C, Goni BW, Muhammad NS, Gabillard D, Balonda PK, Feuzeu L, Atanga I, Yapi B, Habiyambere GG, Danho S, Balestre E, Adams KP, Plazy M, Phelan KPQ, Becquet R. Increasing measles vaccination coverage through supplementation with an SQ-LNS incentive in children aged 6 to 23 months: study protocol of NutriVax-Measles, a superiority pragmatic parallel cluster-randomized controlled trial in Yobe State, Northern Nigeria. Trials. 2025 Nov 19;26(1):525. doi: 10.1186/s13063-025-09243-5.

  PMID: 41257898 DERIVED

Related Links

• Resource: A Review \& Proposed Learning Agenda on Immunization Nutrition Integration

MeSH Terms

Conditions

Measles; Malnutrition

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Renaud Becquet, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No possible to mask intervention due to the specifity of the intervention tested
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two arms superiority opened pragmatic parallel cluster-randomized controlled trial with baseline measure

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 29, 2024
• Study Start: May 7, 2024
• Primary Completion: June 26, 2025
• Study Completion: July 30, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before (protocol, ICF) and during data collection (SAP)
• Access Criteria: Protocol, ICF and SAP on clinicaltrials.gov

Locations

NG (1)