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Tests treatment safety and results for Malnutrition Severe
Official 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.
ClinicalTrials.gov ID: NCT07592260
What this study is testing
- What it's testing
- 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.
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 59. Healthy volunteers may be eligible.
You may be able to join 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...
- Children aged 6 to 59 months will be surveyed on MUAC status and other malnutrition-related issues, while the immunization analysis will focus on...
- 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...
- OptiMAx intervention personnel (e.g. healthcare staff)
You likely can't join 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.
- There is no exclusion criteria for the annual household surveys
- Exclusion criteria for the mixed-methods process evaluation
- \- Parents or guardians under 15 years of age.
See the full eligibility criteria
- 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.
- Age-eligible children with MUAC \<125 or edema will first be treated for acute malnutrition with OptiMA and then resume supplementation with SQ-LNS.
- There is no exclusion criteria for the annual household surveys
- Exclusion criteria for the mixed-methods process evaluation
- \- Parents or guardians under 15 years of age.
The study team makes the final eligibility decision.
Where it's taking place
- Ngouri, Lac Region, Chad
- Mirriah, Zinder Region, Niger
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 59 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ngouri, Lac Region, Chad; Mirriah, Zinder Region, Niger. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.