[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Chad\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100639425","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-100639425",false,"NCT07592260","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.","OptiMAx: Incentivizing EPI Vaccination Via Distribution of SQ-LNS Nutritional Supplementation to Children From Age 6-11 Months Until 18 Months of Age in Rural Chad and Niger, With a Cost Effectiveness Analysis Protocol for a Research Study Nested in the OptiMA Research Study in Ngouri Health District, Lake Region, Chad and Mirriah Health District, Zinder Region, Niger","OptiMAx","Inclusion Criteria:\n\n* 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.\n\nFor the annual household surveys,\n\n* 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;\n* With the informed oral consent of the parents or legal guardian ;\n* Reside in the neighborhoods included in the study.\n\nFor the mixed-methods process evaluation and gender sub-study (to be carried out in the months following implementation).\n\nInclusion criteria\n\n* OptiMAx intervention personnel (e.g. healthcare staff)\n* A group of mothers of children benefiting from the intervention\n* Male partners\u002Fspouses of parents\n* Community members from the sites targeted by the intervention will be recruited for the focus groups.\n* Non-adherents or parents who choose not to continue nutritional supplementation and\u002For vaccination despite their availability under the program will be recruited for interviews.\n* Husbands\u002Fmale partners of non-members will also be surveyed.\n\nExclusion Criteria:\n\n* Age-eligible children with MUAC \\\u003C125 or edema will first be treated for acute malnutrition with OptiMA and then resume supplementation with SQ-LNS.\n\nThere is no exclusion criteria for the annual household surveys\n\nExclusion criteria for the mixed-methods process evaluation\n\n\\- Parents or guardians under 15 years of age.",true,"ALL","6 Months","59 Months",{"count":22,"type":23},20000,"ESTIMATED","INTERVENTIONAL",[26],"NA","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.\n\nSmall-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\".\n\nThe 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.\n\nThe 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.\n\nSecondary objectives include:\n\n* 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.\n* Evaluate the feasibility and reliability of combining measles and pentavalent coverage measurements during annual MUAC-family training campaigns;.\n* 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\n\nThe specific objectives of the process evaluation (with a sub-study on gender), modeling and economic evaluation are as follows:\n\n1. Conduct a process evaluation of the OptiMAx intervention to understand how it works, for whom and where;\n2. 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\u002Fintervention behaviors) and the supply side (provision of intervention services).\n3. Estimate the health impact of the OptiMAx intervention, in terms of nutrition and vaccine-preventable diseases, using mathematical modeling approaches.\n4. Quantify the relative costs associated with the OptiMAx intervention compared with the costs associated with existing vaccination activities in Mirriah, Niger, and Ngouri, Chad.\n5. Estimate the cost-effectiveness of the OptiMAx intervention in Mirriah, Niger, and Ngouri, Chad.",[29,30],"Malnutrition Severe","Vaccination",[32,33,34],"routine immunization","SQ-LNS supplementation","acute malnutrition","RECRUITING","2026-05-11",{"date":38,"type":39},"2026-05-18","ACTUAL",{"date":41,"type":39},"2025-05-01",{"date":43,"type":23},"2026-12",{"name":45,"class":46},"Alliance for International Medical Action","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100595929","phase-4-comparison-of-two-strategies-for-administering-the-r21-matrix-m-vaccine-in-a-context-of-seasonal-malaria-transmission-in-chad-100595929","NCT07038837","Comparison of Two Strategies for Administering the R21-Matrix M Vaccine in a Context of Seasonal Malaria Transmission in Chad","Cluster Randomised Non-inferiority Trial Comparing Malaria Incidence When Implementing R21\u002FMatrix-M Synchronized With Seasonal Malaria Chemoprevention Distribution Versus R21\u002FMatrix-M Given Routinely Through the EPI in Two Health Districts in Chad (CoSAV-R21)","COSAV-R21","Inclusion Criteria:\n\n* • Routine arm\n\n  1. Aged 6 to 11 months at the time of the first R21\u002FMM vaccination (dose 1).\n  2. Residing in a village participating in the study and randomized to the routine arm.\n  3. Oral consent provided by the child's parent\u002Fguardian.\n\n     * Synchronised arm\n\n  \u003C!-- -->\n\n  1. Aged 6 to 59 months at the time of the first R21\u002FMM vaccination (dose 1) during the first 3 rounds of SMC (2025).\n  2. Residing in a village participating in the study and randomized to the synchronized arm.\n  3. Oral consent provided by the child's parent\u002Fguardian.\n\nExclusion Criteria:\n\n* Exclusion criteria for both arms according to Chad national EPI guidelines\n\nMalaria vaccine is not recommended for children with known severe hypersensitivity:\n\n* To a previous dose of a malaria vaccine\n* To a previous dose of hepatitis B vaccine\n* One of the components of the R21\u002FMM vaccine\n\nMild illness - including respiratory tract infections, mild diarrhoea and fever below 38.5° C - is not a contraindication to R21\u002FMM vaccination. Malnutrition and being HIV-seropositive are also not contraindications to R21\u002FMM vaccination.",{"count":56,"type":23},70000,[58],"PHASE4","This is a two-arm, cluster-randomised, phase IV trial conducted in Chad to assess the protective efficacy and impact in real-life conditions of a new strategy for administering the R21\u002FMM malaria vaccine, synchronized within a seasonal malaria chemoprevention (SMC) campaign, among children living in areas of high seasonal malaria transmission.\n\nIn this study, a cluster is defined as the catchment area of a primary care health centre. In Chad, each catchment area is known as a 'zone of responsibility' (French: Zone de Responsibilité' \\[ZR\\]).\n\nTwenty-six (26) of the total 27 ZRs in the districts of Moïssala and Dembo will be randomized in a 1:1 ratio to receive a 4-dose (3 primary doses + 1 booster) R21\u002FMM schedule either (1) integrated into the routine EPI vaccination program (the \"Routine\" control arm), or (2) synchronized with an annual seasonal malaria chemoprevention (SMC) campaign (the \"Synchronized\" intervention arm).\n\nMalaria incidence: R21\u002FMM effectiveness will be assessed using the incidence of biologically confirmed clinical malaria (trial primary endpoint). The incidence of clinical malaria will be determined through enhanced surveillance of malaria cases in health centres and hospitals over a 17-month period (August 2025 - December 2026).\n\nCoverage surveys: Cross-sectional surveys (cluster sampling) will be carried out to measure R21\u002FMM vaccine coverage, SMC coverage, coverage of other malaria prevention measures, and coverage of other EPI vaccines.\n\nNested case-control study: A sub-sample of children admitted to Moïssala District Hospital with severe clinical malaria will be offered the opportunity to participate in a nested case-control study designed to estimate the individual protective efficacy of R21\u002FMM against severe malaria.\n\nAditionnaly, the INTEGREVAC ancillary study's objective is to evaluate the cost-effectiveness, acceptability and feasibility of the synchronised vaccination strategy in the context of the ongoing COSAV-R21 trial, to inform policy decisions for the effective deployment of malaria vaccines in SMC implementation areas.\n\nMethodology and planned work:\n\n(i) A qualitative study using in-depth interviews (IDIs) and group discussions with key stakeholders at the national, health facility, and community levels, including caregivers of children eligible for vaccination, in Chad, at several points during the trial. We will explore stakeholders' and beneficiaries' perceptions and experiences of the synchronised SMC vaccination strategy (trial intervention arm) compared to age-based vaccine administration under the routine immunisation programme (trial control arm), as well as considerations for implementing these strategies. Interviews with healthcare providers, including those administering R21 and SMC, and community members will assess the feasibility of implementing the integrated vaccination strategy via SMC.\n\n(ii) An economic evaluation including a cost-effectiveness analysis and a nested equity analysis will be conducted. The economic evaluation will include a cost analysis to carefully identify and measure the additional costs associated with adding malaria vaccination to the EPI delivery platform and, separately, to the SMC delivery channel. Analysis of key cost drivers will enable us to identify potential efficiency savings, provide evidence for country funding requests (e.g., to GAVI and the Global Fund) and for the malaria vaccine strategy budgeting\u002Fplanning process. Cost-effectiveness and equity analyses of each vaccine delivery strategy will provide evidence to help national programmes plan future malaria vaccine delivery and inform global guidance and on methods of delivering these vaccines, while providing valuable evidence on the real-world cost-effectiveness of malaria vaccination.\n\n(iii) Impact modelling will estimate the costs, impact, and cost-effectiveness of scaling up the intervention approach to the whole of Chad, under different temporal and spatial scenarios.",[61,62],"Malaria Infection","Malaria Vaccines",[64,65,66,67,68,69,70,71,72,73,74,75,76,77],"Vaccine","Malaria","Implementation strategy","Children","Pediatric","synchronized","coverage","prevention","incidence","prevalence","qualitative","mixed methods","cost effectiveness","Seasonal Malaria Chemoprevention","2026-04-10",{"date":80,"type":39},"2026-04-15",{"date":82,"type":39},"2025-06-16",{"date":84,"type":23},"2028-06",{"name":86,"class":46},"Epicentre",1,""]