Immunization ProgramNCT01595542
A School Health Center Intervention to Increase Adolescent Vaccination
A study testing Modified Vaccine Consent Form in people with Immunization Program and School Health Services, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The study will evaluate a health services intervention to increase uptake of adolescent vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five school health centers by improving the consent process for parents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immunization Program, School Health Services, HPV Vaccines
- What is being tested?
- Modified Vaccine Consent Form
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,417 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Feb 2012
- 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
- All students enrolled at target schools
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Student Health Centers
Chapel Hill, North Carolina, 27599
About this study
The study will evaluate a health services intervention to increase uptake of adolescent vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five school health centers by improving the consent process for parents.
- Conditions
- Immunization Program, School Health Services, HPV Vaccines
- Being tested
- Modified Vaccine Consent Form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Vaccine Consent FormBehavioural
Packet of written immunization materials for parents and students which includes the following:
- Cover letter
- Vaccine promotional flyer
- Vaccine information sheets (one for adolescent vaccination and one for other vaccination)
- Improved consent form
- Note advertising a lottery for free movie tickets for returning the consent form
- Self-addressed stamped envelope
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Parents served by experimental school sites received intervention packets including modified vaccine consent form Receives: Behavioral: Modified Vaccine Consent Form |
| Control | No intervention | Did not receive intervention materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline In The Number of Adolescent Vaccines
Change in vaccination rates for HPV, Tdap, meningococcal conjugate and influenza between Fall 2011 (baseline) and Fall 2012.
Measured: 4 months post intervention
Secondary outcomes (1)
Number of Returned Consent Forms Authorizing Vaccination
Number of signed and returned consent forms for adolescent vaccines HPV, Tdap, meningococcal conjugate and influenza in the intervention arm.
Measured: 4 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunization ProgramStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 3,417 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noel T Brewer, PhD, Principal investigator, University of North Carolina Chapel Hill, Department of Health Behavior and Health Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595542
- Sponsor's protocol ID
- 11-1041
- Status last verified
- Mar 2014
- First submitted
- 8 May 2012
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School Health Center Intervention to Increase Adolescent Vaccination
- ClinicalTrials.gov ID
- NCT01595542
- Acronym / sponsor ID
- 11-1041
- Conditions
- Immunization Program, School Health Services, HPV Vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,417 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 May 2012 (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.
The study will evaluate a health services intervention to increase uptake of adolescent vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five school health centers by improving the consent process for parents.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Modified Vaccine Consent FormParents served by experimental school sites received intervention packets including modified vaccine consent form |
| Control | No intervention | –Did not receive intervention materials |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All students enrolled at target schools
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Modified Vaccine Consent FormPacket of written immunization materials for parents and students which includes the following: 1. Cover letter 2. Vaccine promotional flyer 3. Vaccine information sheets (one for adolescent vaccination and one for other vaccination) 4. Improved consent form 5. Note advertising a lottery for free movie tickets for returning the consent form 6. Self-addressed stamped envelope | Behavioural | Intervention |
Primary outcome
Change from Baseline In The Number of Adolescent Vaccines
Time frame: 4 months post intervention
Change in vaccination rates for HPV, Tdap, meningococcal conjugate and influenza between Fall 2011 (baseline) and Fall 2012.
1 secondary outcome
Number of Returned Consent Forms Authorizing Vaccination
Time frame: 4 months post intervention
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 Mar 2014.
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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.
Noel T Brewer, PhD principal investigator
University of North Carolina Chapel Hill, Department of Health Behavior and Health Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Vaccine Consent Form in people with Immunization Program and School Health Services, run by University of North Carolina, Chapel Hill 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 Mar 2014. 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?
Change from Baseline In The Number of Adolescent Vaccines (time frame: 4 months post intervention). 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 Mar 2014.