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.

NCT07592260 | Recruiting

• 2 other identifiers: OptiMAxINV-075117
• Study Type: interventional
• Target: 20,000
• Locations: 2 countries
• Sites: 2

Brief Summary

Malnutrition and infectious disease form a vicious circle, posing a double threat to vulnerable children in low- and middle-income countries. Malnutrition makes children more vulnerable to infectious diseases, while infectious diseases increase the risk of malnutrition. When caught in this cycle, children are far more likely to die or suffer adverse effects on their health and development. High rates of wasting and low immunization coverage also constitute a weakening double burden for already fragile health systems. Every year in these contexts, hundreds of thousands of children are treated for severe wasting, while at the same time suffering repeated and prolonged epidemics of vaccine-preventable diseases such as measles. Rural areas of Chad and Niger are at the heart of this dynamic, recording some of the worst indicators of malnutrition and low vaccination coverage rates. Small-quantity lipid-based nutritional supplements (SQ-LNS) are a category of ready-to-use, nutrient-dense food supplements fortified with micronutrients, designed to prevent malnutrition and improve child survival, growth and development. A recent meta-analysis on SQ-LNS reveals that giving a child just one sachet of SQ-LNS a day for a year can reduce the risk of mortality by 27%, iron-deficiency anemia by 64%, severe wasting by 31% and severe stunting by 17%. The recent World Health Organization (WHO) guideline on complementary feeding of infants and young children aged 6 to 23 months recently recommended the use of SQ-LNS in certain contexts of food insecurity, based on evidence deemed "very safe". The distribution of SQ-LNS is also promising as an incentive for vaccination, as well as for other health services, such as participation in infant growth monitoring programs. Various operational experiences suggest that it is likely to have an impact on increasing vaccination coverage, and a modeling simulation suggests that it would lead to a significant reduction in measles morbidity and mortality. The main objective of OptiMAx is to estimate the effectiveness of a mass SQ-LNS supplementation program coupled with the routine immunization program compared with the routine immunization program alone in terms of vaccination coverage against pentavalent 1 (Niger) and measles 1 (Chad), after 12 months of program implementation, in children aged 12 to 23 months as part of an annual cross-sectional household survey. Secondary objectives include:

• Estimate the effectiveness of a mass SQ-LNS supplementation program combined with the routine Essential Program on Immunization (EPI) compared with the routine EPI alone in children aged 6-18 months, after 12 months of program implementation, in terms of 1) coverage of pentavalent 3 vaccine, malaria and other childhood vaccines, 2) on-time immunization for age-eligible children.
• Evaluate the feasibility and reliability of combining measles and pentavalent coverage measurements during annual MUAC-family training campaigns;.
• Evaluate outcomes of acutely malnourished children who received SQ-LNS supplementation prior to RUTF treatment (as part of their inclusion in the OptiMA study) versus those who did not receive SQ-LNS supplementation The specific objectives of the process evaluation (with a sub-study on gender), modeling and economic evaluation are as follows:
• Conduct a process evaluation of the OptiMAx intervention to understand how it works, for whom and where;
• Understand to what extent and how gender-related facilitations and barriers affect the interaction and uptake of intervention, both on the demand side (health-seeking/intervention behaviors) and the supply side (provision of intervention services).
• Estimate the health impact of the OptiMAx intervention, in terms of nutrition and vaccine-preventable diseases, using mathematical modeling approaches.
• Quantify the relative costs associated with the OptiMAx intervention compared with the costs associated with existing vaccination activities in Mirriah, Niger, and Ngouri, Chad.
• Estimate the cost-effectiveness of the OptiMAx intervention in Mirriah, Niger, and Ngouri, Chad.

Conditions

Malnutrition Severe; Vaccination

Keywords

routine immunization; SQ-LNS supplementation; acute malnutrition

Outcome Measures

Primary Outcomes (2)

• In Mirriah, Niger : Change from baseline in the percentage of zero-dose children assessed in an endline vaccination coverage survey.

  In Mirriah, Niger: Reduction in the percentage of children aged 12-23 months with 0-dose Pentavalent by 7% in the SQ-LNS zone compared with the non-SQ-LNS zone.

  One year after the beginning of SQ-LNS supplementation

• In Ngouri, Chad: Change from baseline in the percentage of children receiving the first dose of measles vaccine assessed in an endline vaccination coverage survey.

  In Ngouri, Chad: The percentage of children aged 12-23 months receiving the first of measles vaccine increased by 13% in the SQ-LNS zone compared with the non-SQ-LNS zone

  One year after the beginning of SQ-LNS supplementation

Secondary Outcomes (8)

• In Ngouri, Chad : Change from baseline in the percentage of zero-dose children assessed in an endline vaccination coverage survey.

  One year after the beginning of SQ-LNS supplementation

• In Mirriah, Niger: Change from baseline in the percentage of children receiving the first dose of measles vaccine assessed in an endline vaccination coverage survey.

  One year after the beginning of SQ-LNS supplementation

• In both sites: Change from baseline in the percentage of children receiving the second dose of measles vaccine assessed in an endline vaccination coverage survey.

  One year after the beginning of SQ-LNS supplementation

• In both sites: Change from baseline in the percentage of children who received all three doses of Pentavalent vaccine assessed in an endline vaccination coverage survey.

  One year after the beginning of SQ-LNS supplementation

• In both sites : Change from baseline in the timeliness of the first dose of measles vaccinations assessed in an endline vaccination coverage survey.

  One year after the beginning of SQ-LNS supplementation

Study Arms (2)

Standard EPI arm

NO INTERVENTION

1\. The standard Expanded Programme on Immunization (EPI) for children, delivered in accordance with the Ministry of Health's routine plans in the community and in health centers and posts, known as the standard EPI arm.

OptiMAx arm

ACTIVE COMPARATOR

2\. the SQ-LNS supplementation program combining EPI for children according to the Ministry of Health's routine plans in the community and in health centers and huts, combined with mass SQ-LNS supplementation integrated with pre-existing services provided in health facilities (health centers and huts) for children aged 6 to 18 months, known as the OptiMAx arm.

Dietary Supplement: small quantity lipid-based supplement (SQ-LNS)

Interventions

small quantity lipid-based supplement (SQ-LNS) DIETARY_SUPPLEMENT

SQ-LNS is a nutritional supplement for children 6-23 months of age.

OptiMAx arm

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All non-malnourished children between 6 and 12 months of age will be eligible for SQ-LNS supplementation until they reach 18 months of age.
• For the annual household surveys,
• Children aged 6 to 59 months will be surveyed on MUAC status and other malnutrition-related issues, while the immunization analysis will focus on children aged 12 to 23 months;
• With the informed oral consent of the parents or legal guardian ;
• Reside in the neighborhoods included in the study.
• For the mixed-methods process evaluation and gender sub-study (to be carried out in the months following implementation).
• OptiMAx intervention personnel (e.g. healthcare staff)
• A group of mothers of children benefiting from the intervention
• Male partners/spouses of parents
• Community members from the sites targeted by the intervention will be recruited for the focus groups.
• Non-adherents or parents who choose not to continue nutritional supplementation and/or vaccination despite their availability under the program will be recruited for interviews.
• Husbands/male partners of non-members will also be surveyed.

You may not qualify if:

• Age-eligible children with MUAC \<125 or edema will first be treated for acute malnutrition with OptiMA and then resume supplementation with SQ-LNS.
• \- Parents or guardians under 15 years of age.

Sponsors & Collaborators

• University of N'Djamena, Chad: collaborator
• Ministere de la Sante Publique et de la Population, Chad: collaborator
• Université André Salifou, Zinder, Niger: collaborator
• Ministère de la Santé Publique, Niger: collaborator
• Alliance for International Medical Action: lead
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (2)

Ngouri hospital

Ngouri, Lac Region, 00000, Chad

RECRUITING

Mirriah hospital

Mirriah, Zinder Region, 70004, Niger

RECRUITING

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Study Officials

• Kevin Phelan, MSc

  ALIMA - The Alliance for International Medical Action

  PRINCIPAL INVESTIGATOR

• Susan Shepherd, MD

  ALIMA - The Alliance for International Medical Action

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Phelan, MSc

CONTACT

+33 664235628; kevin.phelan@alima.ngo

Susan Shepherd, MD

CONTACT

9292257735; susan.shepherd@alima.ngo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In Ngouri, Chad, we will conduct a cluster-randomized clinical trial with covariate-constrained randomization (i.e. vaccine coverage rate and distance from health centers). In Mirriah, Niger, we will conduct a prospective observational study in which we will apply a target trial emulation framework to simulate a cluster-randomized clinical trial.

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 18, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 18, 2026

Record last verified: 2025-05

Locations

NI (1); CH (1)