Actively Recruiting

Phase Not Applicable
Age: 6Months - 59Months
All Genders
Healthy Volunteers
ID07592260

OptiMAx: Testing SQ-LNS Nutritional Supplementation to Increase Vaccination Coverage in Children Aged 6-18 Months in Rural Chad and Niger With Cost Effectiveness Analysis

Led by Alliance for International Medical Action · Updated on 2026-05-18

20000

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Alliance for International Medical Action

Lead Sponsor

L

London School of Hygiene and Tropical Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

Malnutrition and infectious diseases create a harmful cycle that severely affects children in low- and middle-income countries, increasing their risk of death and developmental problems. This study focuses on rural areas of Chad and Niger, where malnutrition rates are high and vaccination coverage is low. Researchers are evaluating whether giving children small-quantity lipid-based nutritional supplements (SQ-LNS) alongside routine immunization improves vaccination rates and child health in these vulnerable populations. The study compares two groups: one receiving the standard Expanded Program on Immunization (EPI) alone, and the other receiving EPI combined with daily SQ-LNS supplementation for children aged 6 to 18 months. SQ-LNS are nutrient-rich, ready-to-use supplements given as a 20-gram sachet per day to support child growth and development. The program runs for 12 months, with SQ-LNS distributed through health centers and community health huts, integrated with existing vaccination services. Participants will be assessed through annual household surveys measuring vaccination coverage, nutritional status using mid-upper arm circumference (MUAC), and treatment outcomes for malnourished children. Additional qualitative research will explore barriers and facilitators to vaccination and supplementation, including gender influences. Researchers will also use modeling and economic analyses to estimate the health impact and cost-effectiveness of the combined program, with follow-up planned for up to one year after starting supplementation.

CONDITIONS

Brief Title

OptiMAx Will Test Whether SQ-LNS Incentivises Vaccination Uptake in Rural Chad and Niger, With a Cost Effectiveness Analysis. It Will Also Look at Whether Having Received SQ-LNS Before Becoming Malnourished Leads to Better Outcomes for Children Treated Under the OptiMA Protocol.

Who Can Participate

Age: 6Months - 59Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 12 months who are not malnourished are eligible for SQ-LNS supplementation until 18 months of age.
  • Children aged 6 to 59 months will be surveyed for nutritional status; vaccination analysis focuses on children aged 12 to 23 months.
  • Parents or legal guardians must provide informed oral consent.
  • Participants must reside in the neighborhoods included in the study.
  • Personnel involved in the OptiMAx intervention and community members may participate in qualitative studies.
  • Mothers of children benefiting from the intervention, their male partners or spouses, non-adherents, and community members will be recruited for interviews and focus groups.
Not Eligible

You will not qualify if you...

  • Children eligible by age with MUAC less than 125 mm or edema will first receive treatment for acute malnutrition before resuming SQ-LNS supplementation.
  • Parents or guardians under 15 years of age are excluded from the mixed-methods process evaluation.
  • There are no exclusion criteria for the annual household surveys.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

SQ-LNS Supplementation and Vaccination

Duration - Up to 12 months until participants reach 18 months of age

Participants aged 6 to 12 months receive daily small quantity lipid-based nutritional supplements (SQ-LNS) combined with routine Expanded Programme on Immunization (EPI) services at health centers or huts. This stage aims to increase vaccination coverage and improve nutritional status through monthly supplement distribution integrated with immunization visits.

Monthly visits for supplement distribution and vaccination

Follow-up and Assessment

Duration - Assessment at approximately 1 year after beginning SQ-LNS supplementation

After supplementation ends, participants aged 12 to 23 months are assessed for vaccination coverage, nutritional status, and treatment outcomes for acute malnutrition to evaluate the impact of the intervention.

1 visit (in-person) for endline vaccination coverage survey and nutritional assessment

Trial Site Locations

Total: 2 locations

1

Ngouri hospital

Ngouri, Lac Region, Chad, 00000

Actively Recruiting

2

Mirriah hospital

Mirriah, Zinder Region, Niger, 70004

Actively Recruiting

Loading map...

Research Team

K

Kevin Phelan, MSc

S

Susan Shepherd, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Similar Trials

A Phase II Study on Adjuvant Vaccination with Dendritic Cell...

Head Neck Tumors

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Systematic review of social determinants of childhood immunisation in low- and middle-income countries and equity impact analysis of childhood vaccination coverage in Nigeria.

Sarah V Williams, Tanimola Akande, Kaja Abbas

https://pubmed.ncbi.nlm.nih.gov/38446836

Contribution of vaccination to improved survival and health: modelling 50 years of the Expanded Programme on Immunization.

Andrew J Shattock, Helen C Johnson, So Yoon Sim...

https://pubmed.ncbi.nlm.nih.gov/38705159

Factors associated with non-response and nutritional status of non-responders at 6-month post-discharge: a cohort study nested in a MUAC-based nutrition programme for acutely malnourished children in Mirriah, Niger.

Maguy Daures, Jérémie Hien, Cécile Cazes...

https://pubmed.ncbi.nlm.nih.gov/39206006

Treatment outcomes and associated factors for hospitalization of children treated for acute malnutrition under the OptiMA simplified protocol: a prospective observational cohort in rural Niger.

Kevin Phelan, Benjamin Seri, Maguy Daures...

https://pubmed.ncbi.nlm.nih.gov/37475774