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Background <p>Undernutrition and infectious diseases form a vicious cycle that poses a dual threat to vulnerable children in low- and middle-income countries. Integrating small-quantity lipid-based nutrient supplements (SQ-LNS) distribution into routine immunization services in children 6–23&#xa0;months may act as both a nutritional intervention and as an incentive for increased vaccine uptake.</p> Methods <p>We will conduct a two-arm superiority pragmatic parallel cluster-randomized controlled trial with baseline measures in 20 wards of Nguru and Karasuwa Local Government Areas, Yobe State, Northeast Nigeria. Wards will be randomly allocated 1:1 to either the standard National Program on Immunization (NPI) arm or the NutriVax arm, which combines NPI with SQ-LNS distribution. After up to 12&#xa0;months of implementation, measles immunization coverage will be assessed at two levels: population-level coverage in children aged 12–23&#xa0;months (primary outcome, endline cross-sectional survey) and individual-level coverage in children aged 6–12&#xa0;months (key secondary outcome, longitudinal survey). Each cross-sectional survey (baseline and endline) will include 1560 participants. The longitudinal survey will enroll 600 participants. Sampling will use a multi-stage design with probability proportional to size and systematic random household selection. All outcomes will be analyzed by intention-to-treat. Qualitative interviews will assess feasibility and acceptability. Cost-efficiency differences between arms will be estimated using an incremental cost-efficiency ratio.</p> Discussion <p>To our knowledge, this is the first trial to evaluate whether a preventive nutrition supplement can also serve as an incentive to increase vaccination coverage. Findings will provide evidence to guide governments and donors in settings where high rates of undernutrition and low immunization coverage persist as major public health challenges.</p> Trial registration <p>Protocol Number NCT06387511 (clinicaltrials.gov).</p>

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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

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  • 发表日期：

    2025年11月19日

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  • Cécile Cazes,
  • Baba Waru Goni,
  • Nuru Suleiman Muhammad,
  • Delphine Gabillard,
  • Pierrot Kalubi Balonda,
  • Loic Feuzeu,
  • Irine Atanga,
  • Brice Yapi,
  • Gemma Guylène Habiyambere,
  • Serge Danho,
  • Eric Balestre,
  • Katherine P. Adams,
  • Mélanie Plazy,
  • Kevin P. Q. Phelan,
  • Renaud Becquet

摘要

Background

Undernutrition and infectious diseases form a vicious cycle that poses a dual threat to vulnerable children in low- and middle-income countries. Integrating small-quantity lipid-based nutrient supplements (SQ-LNS) distribution into routine immunization services in children 6–23 months may act as both a nutritional intervention and as an incentive for increased vaccine uptake.

Methods

We will conduct a two-arm superiority pragmatic parallel cluster-randomized controlled trial with baseline measures in 20 wards of Nguru and Karasuwa Local Government Areas, Yobe State, Northeast Nigeria. Wards will be randomly allocated 1:1 to either the standard National Program on Immunization (NPI) arm or the NutriVax arm, which combines NPI with SQ-LNS distribution. After up to 12 months of implementation, measles immunization coverage will be assessed at two levels: population-level coverage in children aged 12–23 months (primary outcome, endline cross-sectional survey) and individual-level coverage in children aged 6–12 months (key secondary outcome, longitudinal survey). Each cross-sectional survey (baseline and endline) will include 1560 participants. The longitudinal survey will enroll 600 participants. Sampling will use a multi-stage design with probability proportional to size and systematic random household selection. All outcomes will be analyzed by intention-to-treat. Qualitative interviews will assess feasibility and acceptability. Cost-efficiency differences between arms will be estimated using an incremental cost-efficiency ratio.

Discussion

To our knowledge, this is the first trial to evaluate whether a preventive nutrition supplement can also serve as an incentive to increase vaccination coverage. Findings will provide evidence to guide governments and donors in settings where high rates of undernutrition and low immunization coverage persist as major public health challenges.

Trial registration

Protocol Number NCT06387511 (clinicaltrials.gov).