Coverage of Vitamin A SupplementationNCT06949930
OPTIMIZING ROUTINE DELIVERY OF ESSENTIAL CHILD HEALTH AND NUTRITION PACKAGE THROUGH PRIMARY HEALTH CARE CONTACTS
A study testing Optimized package of child essential health and nutrition services and Standard package of essential child and nutrition services in people with Coverage of Vitamin A Supplementation and Coverage of Immunization, run by Nutrition International at 2 sites in 2 countries.
Trial summary
The primary objective of the study is to assess whether optimization of an essential package of health and nutrition services for children under five years of age using vitamin A supplementation touch points (i.e., the implementation model) in selected areas in Kenya and Senegal will increase the coverage of vitamin A… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coverage of Vitamin A Supplementation, Coverage of Immunization, Feasibility and Fidelity of Implementation
- What is being tested?
- Optimized package of child essential health and nutrition services and Standard package of essential child and nutrition services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,928 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Feb 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Caregivers of children 12-59 months of age
- Health service providers
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Kenya1 site, 1 recruiting
- Recruiting
Nutrition International- Kenya
Nairobi
Elijah Mbiti, Ph.D., +254709688000, embiti@nutritionintl.org
Enock Matoke Makori, +254709688000, emakori@nutritionintl.org
Senegal1 site, 1 recruiting
- Recruiting
Nutrition International - Senegal
Dakar
Banda Ndiaye, +254780457298, bndiaye@nutritionintl.org
Marcel Yanga, +221338693002, marcelyanga87@gmail.com
About this study
The primary objective of the study is to assess whether optimization of an essential package of health and nutrition services for children under five years of age using vitamin A supplementation touch points (i.e., the implementation model) in selected areas in Kenya and Senegal will increase the coverage of vitamin A supplementation and the coverage of other child health and nutrition services. In addition, the study will also assess the feasibility of the implementation model and the drivers of coverage outcomes.
Read the detailed description
Background: Countries have made significant progress over the last 20 years in improving child survival with under five mortality rates. Despite this progress, many countries still experience inequalities in the coverage of several essential child health and nutrition services, including vitamin A supplementation (VAS), growth monitoring and promotion (GMP), immunization, and regular nutrition screening for early detection of malnutrition. Optimizing the delivery of an Essential Child Health and Nutrition Package ("essential package") may address this issue.
Objective: The primary objective of the study is to assess the effect of optimizing the health system for the delivery of the essential package (the "implementation model"), on the coverage of VAS and on the coverage of immunization (as measured by vaccination for measles). In addition, the study will also assess the feasibility of the implementation model and the drivers of coverage outcomes.
Methods: Target population will be children 12-59 months of age and their caregivers in Kisii County in Kenya and Fatick Region in Senegal. The study will use an effectiveness-research implementation hybrid design with two arms: 1) health system will be optimized to deliver VAS to all children 12-59 months of age using all the routine primary health care (PHC) contact points plus current standard of care (Intervention) and 2) current standard of care (Control). The study will be conducted for a period of 18 months. The optimization model will be implemented for 12 months. Baseline and endline surveys that will collect quantitative and qualitative data will be conducted to assess the coverage of essential child health and nutrition services in both arms from study participants per arm in both baseline and endline surveys and to assess implementation feasibility. Implementation fidelity will be assessed through monthly visits by the research team to health facilities.
- Conditions
- Coverage of Vitamin A Supplementation, Coverage of Immunization, Feasibility and Fidelity of Implementation
- Being tested
- Optimized package of child essential health and nutrition services, Standard package of essential child and nutrition services
- Keywords
- VAS, immunization, coverage, hybrid effectiveness-implementation research study, essential child health and nutrition services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized package of child essential health and nutrition servicesOther
Optimized package of child essential health and nutrition services
Standard package of essential child and nutrition servicesOther
Standard package of essential child and nutrition services
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm receives the optimized package of child essential health and nutrition services Receives: Other: Optimized package of child essential health and nutrition services |
| Control | Other | The control arm receives the current standard package of health and nutrition services Receives: Other: Standard package of essential child and nutrition services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children who received their age-appropriate VAS
The proportion of children 12-59 months of age who received their age-appropriate VAS
Measured: From enrollment to the end of intervention at 12 months
Children who are immunized with measles vaccine
Proportion of children 12-23 months of age who are immunized with one dose of measles (MR1) in Kenya Proportion of children 24-35 months of age who are immunized with the second dose of measles (MR2) in Senegal
Measured: From enrollment to the end of intervention at 12 months
Implementation feasibility of new model perceived by health service providers, as assessed by key informant interviews and focus groups
Feasibility of implementation of the new model as perceived by health service providers will be assessed via key informant interviews and focus groups to enquire on:
- Implementation barriers and facilitators ii. Practicality of implementing the optimization model within context and resource availability iii. Program disruption due to the implementation of the model iv. Need for infrastructure to implement the model v. Sustainability of the optimized model.
All qualitative information will be triangulated to assess feasibility of implementation of the new model
Measured: From enrollment to the end of intervention at 12 months
Fidelity of implementing the new model
Fidelity of implementation will be assessed by measuring:
- The proportion of health facilities preparing and using integrated microplans. ii. The proportion of supportive supervision visits carried out in an integrated way. iii. The proportion of service delivery points providing services in an integrated way
Fidelity will be achieved if the three parameters score at least 80%.
Measured: From enrollment to the end of intervention at 12 months
Secondary outcomes (6)
Co-coverage of VAS and measles vaccine
Proportion of children 12-23 months of age who have received both their age-appropriate VAS and their age-appropriate vaccines (as measured by measles one) in Kenya Proportion of children 24-35 months of age who have received both their age-appropriate VAS and their age-appropriate vaccines (as measured by measles two) in Senegal
Measured: From enrollment to the end of intervention at 12 months
Children screened for malnutrition in the last 6 months
The proportion of children 12-59 months of age who were screened for malnutrition in the last 6 months
Measured: From enrollment to the end of intervention at 12 months
Children who have received growth monitoring service
The proportion of children 12-59 months who have received growth monitoring service
Measured: From enrollment to the end of intervention at 12 months
Children who have received age-appropriate immunizations
The proportion of children 12-59 months who have received age-appropriate immunizations according to EPI schedule
Measured: From enrollment to the end of intervention at 12 months
Caregivers who report receiving more than one service
The proportion of caregivers of children 12-59 months of age who reported ever receiving more than one of the following services within the Essential Child Health and Nutrition Package during the same visit
Measured: From enrollment to the end of intervention at 12 months
Caregivers who indicate are satisfied with the way the services are being delivered
The proportion of caregivers indicate are satisfied with the way the Essential Child Health and Nutrition Package services are being delivered to their children
Measured: From enrollment to the end of intervention at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start21 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coverage of Vitamin A SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Implementation model aims to optimize health workforce training and supervision, service delivery, health data and information, and leadership and governance as so to maximize VAS coverage and in doing so also improve coverage of other services
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,928 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrition International
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Ministry of Health, Cheikh Anta Diop University, Senegal, Ministry of Health, Senegal, Henike Consultants
- Responsible party
- Principal investigator, Daniel Lopez de Romana, Nutrition International
- Investigators
- Mandana Arabi, M.D., Ph.D., Principal investigator, Nutrition InternationalElijah Mbiti, Ph.D., Principal investigator, Nutrition International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949930
- Sponsor's protocol ID
- Nutrition International
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIZING ROUTINE DELIVERY OF ESSENTIAL CHILD HEALTH AND NUTRITION PACKAGE THROUGH PRIMARY HEALTH CARE CONTACTS
- ClinicalTrials.gov ID
- NCT06949930
- Acronym / sponsor ID
- Nutrition International
- Conditions
- Coverage of Vitamin A Supplementation, Coverage of Immunization, Feasibility and Fidelity of Implementation
- Keywords
- VAS, immunization, coverage, hybrid effectiveness-implementation research study, essential child health and nutrition services
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,928 participants (estimated)
- Lead sponsor
- Nutrition InternationalUniversity, hospital or other
- Collaborators
- Kenya Ministry of Health, Cheikh Anta Diop University, Senegal, Ministry of Health, Senegal, Henike Consultants
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess whether optimization of an essential package of health and nutrition services for children under five years of age using vitamin A supplementation touch points (i.e., the implementation model) in selected areas in Kenya and Senegal will increase the coverage of vitamin A supplementation and the coverage of other child health and nutrition services. In addition, the study will also assess the feasibility of the implementation model and the drivers of coverage outcomes.
Detailed description
Background: Countries have made significant progress over the last 20 years in improving child survival with under five mortality rates. Despite this progress, many countries still experience inequalities in the coverage of several essential child health and nutrition services, including vitamin A supplementation (VAS), growth monitoring and promotion (GMP), immunization, and regular nutrition screening for early detection of malnutrition. Optimizing the delivery of an Essential Child Health and Nutrition Package ("essential package") may address this issue.
Objective: The primary objective of the study is to assess the effect of optimizing the health system for the delivery of the essential package (the "implementation model"), on the coverage of VAS and on the coverage of immunization (as measured by vaccination for measles). In addition, the study will also assess the feasibility of the implementation model and the drivers of coverage outcomes.
Methods: Target population will be children 12-59 months of age and their caregivers in Kisii County in Kenya and Fatick Region in Senegal. The study will use an effectiveness-research implementation hybrid design with two arms: 1) health system will be optimized to deliver VAS to all children 12-59 months of age using all the routine primary health care (PHC) contact points plus current standard of care (Intervention) and 2) current standard of care (Control). The study will be conducted for a period of 18 months. The optimization model will be implemented for 12 months. Baseline and endline surveys that will collect quantitative and qualitative data will be conducted to assess the coverage of essential child health and nutrition services in both arms from study participants per arm in both baseline and endline surveys and to assess implementation feasibility. Implementation fidelity will be assessed through monthly visits by the research team to health facilities.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Implementation model aims to optimize health workforce training and supervision, service delivery, health data and information, and leadership and governance as so to maximize VAS coverage and in doing so also improve coverage of other services
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Optimized package of child essential health and nutrition servicesThe intervention arm receives the optimized package of child essential health and nutrition services |
| Control | Other | Other: Standard package of essential child and nutrition servicesThe control arm receives the current standard package of health and nutrition services |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Caregivers of children 12-59 months of age
- Health service providers
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized package of child essential health and nutrition servicesOptimized package of child essential health and nutrition services | Other | Intervention |
| Standard package of essential child and nutrition servicesStandard package of essential child and nutrition services | Other | Control |
Primary outcome
Children who received their age-appropriate VAS
Time frame: From enrollment to the end of intervention at 12 months
The proportion of children 12-59 months of age who received their age-appropriate VAS
Children who are immunized with measles vaccine
Time frame: From enrollment to the end of intervention at 12 months
Proportion of children 12-23 months of age who are immunized with one dose of measles (MR1) in Kenya Proportion of children 24-35 months of age who are immunized with the second dose of measles (MR2) in Senegal
Implementation feasibility of new model perceived by health service providers, as assessed by key informant interviews and focus groups
Time frame: From enrollment to the end of intervention at 12 months
Feasibility of implementation of the new model as perceived by health service providers will be assessed via key informant interviews and focus groups to enquire on: i. Implementation barriers and facilitators ii. Practicality of implementing the optimization model within context and resource availability iii. Program disruption due to the implementation of the model iv. Need for infrastructure to implement the model v. Sustainability of the optimized model. All qualitative information will be triangulated to assess feasibility of implementation of the new model
Fidelity of implementing the new model
Time frame: From enrollment to the end of intervention at 12 months
Fidelity of implementation will be assessed by measuring: i. The proportion of health facilities preparing and using integrated microplans. ii. The proportion of supportive supervision visits carried out in an integrated way. iii. The proportion of service delivery points providing services in an integrated way Fidelity will be achieved if the three parameters score at least 80%.
6 secondary outcomes
Co-coverage of VAS and measles vaccine
Time frame: From enrollment to the end of intervention at 12 months
Children screened for malnutrition in the last 6 months
Time frame: From enrollment to the end of intervention at 12 months
Children who have received growth monitoring service
Time frame: From enrollment to the end of intervention at 12 months
Children who have received age-appropriate immunizations
Time frame: From enrollment to the end of intervention at 12 months
Caregivers who report receiving more than one service
Time frame: From enrollment to the end of intervention at 12 months
Caregivers who indicate are satisfied with the way the services are being delivered
Time frame: From enrollment to the end of intervention at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mandana Arabi, M.D., Ph.D. principal investigator
Nutrition International
Elijah Mbiti, Ph.D. principal investigator
Nutrition International
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized package of child essential health and nutrition services and Standard package of essential child and nutrition services in people with Coverage of Vitamin A Supplementation and Coverage of Immunization, run by Nutrition International at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lopez de Romana, Ph.D. (613-782-6837, dlopezderomana@nutritionintl.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children who received their age-appropriate VAS (time frame: From enrollment to the end of intervention at 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.