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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
Background Malnutrition and infectious disease form a vicious cycle, 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 debilitating double burden for already fragile health systems. Every year, in these contexts, hundreds of thousands of children are treated for severe wasting, while suffering repeated and prolonged epidemics of vaccine-preventable diseases such as measles.
To reverse this dynamic, ALIMA (The Alliance for International Medical Action), a Dakar-based African medical alliance linking national Nongovernmental Organizations (NGOs) and international research institutes, has proposed a research program called OptiMAx to assess the potential impact of joint programming of monthly small-batch lipid-based nutritional supplementation (SQ-LNS) coupled with immunization services, with a particular focus on documenting the evolution of Pentavalent 3 and Measles 1 coverage in the 12-23 month age group.
Rural areas in Niger and Chad are at the center of this dynamic, recording some of the worst indicators of malnutrition, with recurrent epidemics of measles and sporadic outbreaks of diphtheria and whooping cough. Yet only 28.6% of children under the age of two in Ngouri (Chad) and 4% in Mirriah (Niger) have a minimum acceptable diet (1, 2).
Malnutrition indicators and immunization coverage rates in Chad and Niger are among the worst in the world. Stunting and wasting affect 28% and 8.6% of children respectively in Chad, and 47.0% and 12.2% in Niger. Stunting affects 35.7% of children under 5 (U5) in Ngouri, Chad, and 51.5% in Mirriah, Niger. Wasting affects 13.3% and 17.6% of children in Ngouri and Mirriah respectively. Vaccination coverage against measles 1 by card verification and recall of mothers/accompanying adults is 75.1% nationally in Chad and 83.5% in Niger. It is lower in Ngouri in Chad (67.3%) and Mirriah in Niger (74.3%) (1,2).
High rates of wasting and inadequate immunization coverage represent a debilitating double burden for fragile health systems, as in Chad and Niger, where hundreds of thousands of children are treated for severe wasting and repeated, prolonged epidemics of vaccine-preventable diseases such as measles occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
- •Inclusion criteria
- •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.
排除标准
- •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.