Up-to-date Immunization Status for Children in Child CareIPiCCNCT01773759
Immunization Protection in Child Care (IPiCC) Project
A study testing Intervention child care programs in people with Up-to-date Immunization Status for Children in Child Care, run by University of Utah at 1 site in United States.
Trial summary
Ensuring that all children are fully immunized against vaccine-preventable diseases is a critical public health issue. Child care programs are critical targets for efforts to increase the proportion of infants and young children who are fully immunized. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Up-to-date Immunization Status for Children in Child Care
- What is being tested?
- Intervention child care programs
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child care programs not currently registered to use the Utah State Immunization Information System (USIIS) in Utah counties with acceptable USIIS coverage will be included.
Who cannot join
- Child care programs in Utah counties with lower than acceptable USIIS coverage will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategies to Improve Vaccination Coverage in Child Care Centers and Preschools
Ensuring that all children are fully immunized against vaccine-preventable diseases is a critical public health issue. Child care programs are critical targets for efforts to increase the proportion of infants and young children who are fully immunized. The primary objective of this proposal is to rigorously examine current state, local government, and child care providers' efforts and barriers to ensuring that all enrolled children are up-to-date for required immunizations and to evaluate strategies to improve immunization coverage in child care programs.
Read the detailed description
Specific Aim 1 will describe Utah state and local government activities to ensure compliance of child care programs with state immunization requirements and identify government's barriers to ensuring compliance.
Specific Aim 2 will describe child care program staffs' knowledge, attitudes, and activities related to ensuring that all children are up-to-date for required immunizations and identify program barriers to ensuring up-to-date status.
Specific Aim 3 will evaluate at least 3 strategies to ensure that all children enrolled in child care programs are up-to-date for required immunizations. Aims 1 and 2 will guide the design of these strategies. Specific strategies proposed for Aim 3 are to: 1) design and pilot test an intervention to increase child care program use of the Utah State Immunization Information System (USIIS), 2) design an online immunization education module and conduct a pilot randomized controlled trial to determine whether use of the module changes child care providers' knowledge, attitudes, and activities and increases the proportion of children who are up-to-date for required immunizations; and 3) conduct a pilot randomized controlled trial to determine whether a quality improvement intervention implemented in child care programs increases the proportion of children who are up-to-date for required immunizations.
- Being tested
- Intervention child care programs
- Keywords
- Immunizations, Child care, School health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention child care programsBehavioural
Interventions will be designed based on findings from Aims 1 and 2, will include outreach and education, and may include on-site demonstration and USIIS training or peer tutoring.
| Study group | Role | What they receive |
|---|---|---|
| Intervention child care programs | Experimental | Intervention child care programs will receive immunization outreach and education. Receives: Behavioral: Intervention child care programs |
| Control child care programs | No intervention | Control programs will receive no more than usual training regarding childhood immunization requirements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children enrolled in child care program up-to-date for required immunizations
Proportion of children up-to-date for all state required childhood immunizations in the Utah State Immunization Information System (USIIS)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startSep 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Up-to-date Immunization Status for Children in Child CareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Utah Department of Health
- Responsible party
- Principal investigator, Julie Shakib, University of Utah
- Investigators
- Julie H. Shakib, DO, MPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773759
- Sponsor's protocol ID
- IP000500
- Other IDs
- RFA-IP-11-006
- Acronym
- IPiCC
- Status last verified
- Apr 2017
- First submitted
- 13 Jan 2013
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Improve Vaccination Coverage in Child Care Centers and Preschools
- ClinicalTrials.gov ID
- NCT01773759
- Acronym / sponsor ID
- IPiCC / IP000500
- Keywords
- Immunizations, Child care, School health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Utah Department of Health
- Study start
- Sep 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Jan 2013 (estimated)
- 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.
Ensuring that all children are fully immunized against vaccine-preventable diseases is a critical public health issue. Child care programs are critical targets for efforts to increase the proportion of infants and young children who are fully immunized. The primary objective of this proposal is to rigorously examine current state, local government, and child care providers' efforts and barriers to ensuring that all enrolled children are up-to-date for required immunizations and to evaluate strategies to improve immunization coverage in child care programs.
Detailed description
Specific Aim 1 will describe Utah state and local government activities to ensure compliance of child care programs with state immunization requirements and identify government's barriers to ensuring compliance.
Specific Aim 2 will describe child care program staffs' knowledge, attitudes, and activities related to ensuring that all children are up-to-date for required immunizations and identify program barriers to ensuring up-to-date status.
Specific Aim 3 will evaluate at least 3 strategies to ensure that all children enrolled in child care programs are up-to-date for required immunizations. Aims 1 and 2 will guide the design of these strategies. Specific strategies proposed for Aim 3 are to: 1) design and pilot test an intervention to increase child care program use of the Utah State Immunization Information System (USIIS), 2) design an online immunization education module and conduct a pilot randomized controlled trial to determine whether use of the module changes child care providers' knowledge, attitudes, and activities and increases the proportion of children who are up-to-date for required immunizations; and 3) conduct a pilot randomized controlled trial to determine whether a quality improvement intervention implemented in child care programs increases the proportion of children who are up-to-date for required immunizations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention child care programs | Experimental | Behavioral: Intervention child care programsIntervention child care programs will receive immunization outreach and education. |
| Control child care programs | No intervention | –Control programs will receive no more than usual training regarding childhood immunization requirements. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Child care programs not currently registered to use the Utah State Immunization Information System (USIIS) in Utah counties with acceptable USIIS coverage will be included.
Key exclusion criteria (1 listed)
- Child care programs in Utah counties with lower than acceptable USIIS coverage will be excluded.
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 |
|---|---|---|
| Intervention child care programsInterventions will be designed based on findings from Aims 1 and 2, will include outreach and education, and may include on-site demonstration and USIIS training or peer tutoring. | Behavioural | Intervention child care programs |
Primary outcome
Children enrolled in child care program up-to-date for required immunizations
Time frame: Up to 2 years
Proportion of children up-to-date for all state required childhood immunizations in the Utah State Immunization Information System (USIIS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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. This study is not recruiting at the moment.
Julie H. Shakib, DO, MPH principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention child care programs in people with Up-to-date Immunization Status for Children in Child Care, run by University of Utah at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children enrolled in child care program up-to-date for required immunizations (time frame: Up to 2 years). 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 13 Apr 2017.