Nutrition Clinical Trial
Official title:
NutriVax-Measles: Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months, a Pragmatic Parallel Cluster-randomized Controlled Trial in Yobe State, Northern Nigeria
Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services. The investigators will estimate 1) the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, 1) in children aged 12-23 months in the end line cross-sectional household survey, 2) in children aged 6-12 months at inclusion, in a longitudinal 12 months follow-up survey. Secondary objectives are to assess the barriers and facilitators from the perspectives of parents/legal guardian of children, health care providers and community health workers and to assess the cost-efficiency of the This study will be implemented in 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria. This is a pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and end line cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized subsample of health facilities. Clusters will be randomly allocated at a ratio of 1:1 either to the standard arm or to the NutriVax arm: - The standard Expanded Program on Immunization (EPI) in children aged 6-23 months delivered according to the Ministry of Health's routine plans in the community and at health centres and health posts, named the standard EPI arm; - The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm.
Status | Recruiting |
Enrollment | 3720 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 23 Months |
Eligibility | - Baseline and endline cross-sectional household surveys Inclusion criteria - Aged 12-23 months; - With oral informed consent of parent or legal guardian; - Residing in the catchment settlements of wards included in the study. Exclusion criteria - Included in the longitudinal follow-up. - Longitudinal follow-up survey Inclusion criteria - Aged 6-12 months; - With written informed consent of parent or legal guardian; - Residing in the catchment settlements of wards included in the study. Exclusion criteria - Acute malnutrition criteria as per the WHO definition (i.e. MUAC< 125 or WHZ < -2 or nutritional edema); - - Known medical complication that requires referral for hospitalization; - Known allergies to SQ-LNS or SQ-LNS contraindication; - Any other condition interfering with protocol adherence or the ability to give informed consent, in the judgment of the Field Investigator Sampling for HHS and LS will be carried out in three stages in each LGA using probability proportional to size (PPS). - Qualitative feasibility and acceptability survey Inclusion - Parent or legal guardian of a child aged 6-23 months and residing in the catchment settlements of wards included in the study, or Health worker of the ministry of health involved in the study,or Community representative or Community health workers; - With written informed consent. Exclusion criteria - None |
Country | Name | City | State |
---|---|---|---|
Nigeria | All Primary Health Care Centers of Nguru and Karasuwa LGAs | Damaturu | Yobe |
Lead Sponsor | Collaborator |
---|---|
Alliance for International Medical Action | Eleanor Crook Foundation, Gavi, The Vaccine Alliance, Institut National de la Santé Et de la Recherche Médicale, France, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Yobe State Ministry of Health, Nigeria |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measles vaccine coverage in children aged 12-23 months | The proportion of children aged 12-23 months in the endline survey who have received at least one dose of measles vaccine, as reported on their vaccination card. | Measured after one year after of intervention implementation. | |
Primary | Measles vaccine coverage in children 6-12 months at inclusion | The proportion of children aged 6-12 months at inclusion in the longitudinal follow-up survey, who have received at least one additional dose of measles vaccine, as reported on their vaccination card, administered between inclusion and the end of follow-up. | Measured after one year after of intervention implementation. | |
Secondary | Measles vaccine coverage: at least one dose | The proportion of children with at least one measles vaccine as reported on a vaccination card or by recall. | Measured after one year after of intervention implementation. | |
Secondary | Measles vaccine coverage : two doses | The proportion of children with a measles 2 vaccine as reported on a vaccination card or by recall | Measured after one year after of intervention implementation. | |
Secondary | Timeliness of measles 1 vaccination | Proportion of children with Measles 1 vaccine received within 30 days of turning 9 months by card | Measured after one year after of intervention implementation. | |
Secondary | Other infant vaccines coverage | Proportion of children with Pentavalent 1 and 3, yellow fever, meningitis vaccine as reported on a vaccination card or by recall | Measured after one year after of intervention implementation. | |
Secondary | Zero-dose | Proportion of children with No measles + pentavalent + yellow fever + meningitis vaccines reported on a vaccination card or by recall. | Measured after one year after of intervention implementation. | |
Secondary | Fully immunization | Proportion of children who had received all childhood vaccinations recommended by the Nigeria MOH. | Measured after one year after of intervention implementation. | |
Secondary | Acceptability | Barriers and facilitators to access health care centres and receive SQ-LNS mass supplementation implemented as a routine preventive program nested in health facilities activities | Measured after 2 months and one year after of intervention implementation. | |
Secondary | Cost-efficiency | • Cost per child vaccinated and supplemented compared to cost per child vaccinated only, using a facility and caregiver perspectiveto identify all provider and caregiver costs associated with treatment. | Measured after one year after of intervention implementation. |
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