Adolescent Immunizations Among Clinic PopulationNCT01600560
Facilitating Completion of HPV Vaccination
An observational study of Adolescent Immunizations Among Clinic Population, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
With the surge in use of electronic media among adolescents, a strategy that has been utilized to increase HPV4 uptake in girls has been reminder text messaging to their parents. Read more about this study
- Who is it for?
- Ages 11 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Immunizations Among Clinic Population
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 5 Jul 2016
- Phase
- Observational
- 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 11 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescent males and females age 11-21 at a Pediatric clinic
Who may be able to join
- incomplete immunization
Who cannot join
- complete immunization
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Pediatric Clinic
Chapel Hill, North Carolina, 27599
About this study
Official title: Facilitating the Completion of the 3-Dose Series of HPV Vaccination in Males and Females
With the surge in use of electronic media among adolescents, a strategy that has been utilized to increase HPV4 uptake in girls has been reminder text messaging to their parents. To date, no published study has looked at the effectiveness of texting adolescents themselves (especially boys) rather than their parents OR compared texting to social network sites to increase HPV knowledge and uptake of HPV vaccination in boys. Interactive technology-based interventions targeted at youth are feasible in North Carolina for the following reasons: (1) through the NC Minors' Consent Law adolescents can consent to the prevention, diagnosis, and treatment of sexually transmitted diseases (N.C. Gen. Stat. § 90-21.5(a); and (2) many school based health centers can provide immunizations. Since HPV infection is a sexually transmitted infection, NC teens do not have to get consent for HPV prevention (i.e., vaccination).
To optimize HPV vaccination in young people, especially males, communication strategies are needed to motivate adolescents to get themselves vaccinated. Texting has been demonstrated to be a feasible, popular, and effective method of sexual health promotion to young people with a relatively low withdrawal rate, positive feedback, and an observed improvement in sexual health knowledge and STI testing (12). Social media communication strategies are a new and potentially effective channel for communicating public health messages about HPV vaccine that are also likely to increase HPV initiation and completion among adolescent girls in addition to boys.
According to the NC Immunization Registry, as of March 8, 2011, only 2% of boys ages 9-13 had received at least one dose of HPV vaccine. In the investigators continuity clinic less than 50 percent of adolescents are fully immunized. This project will identify social behavioral, emotional, and cognitive correlates and predictors that help explain why teens pursue, complete, and do not complete HPV vaccination, and develop a social media communication intervention collaboratively with teens to increase HPV vaccine initiation and completion.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Social media | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination uptake
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completion9 Nov 2015
- Study completion5 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Immunizations Among Clinic PopulationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara Coyne-Beasley, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600560
- Sponsor's protocol ID
- 11-1551
- Status last verified
- Apr 2017
- First submitted
- 15 May 2012
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating the Completion of the 3-Dose Series of HPV Vaccination in Males and Females
- ClinicalTrials.gov ID
- NCT01600560
- Acronym / sponsor ID
- 11-1551
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- 9 Nov 2015 (actual)
- Study completion
- 5 Jul 2016 (actual)
- First posted
- 17 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.
With the surge in use of electronic media among adolescents, a strategy that has been utilized to increase HPV4 uptake in girls has been reminder text messaging to their parents. To date, no published study has looked at the effectiveness of texting adolescents themselves (especially boys) rather than their parents OR compared texting to social network sites to increase HPV knowledge and uptake of HPV vaccination in boys. Interactive technology-based interventions targeted at youth are feasible in North Carolina for the following reasons: (1) through the NC Minors' Consent Law adolescents can consent to the prevention, diagnosis, and treatment of sexually transmitted diseases (N.C. Gen. Stat. § 90-21.5(a); and (2) many school based health centers can provide immunizations. Since HPV infection is a sexually transmitted infection, NC teens do not have to get consent for HPV prevention (i.e., vaccination).
To optimize HPV vaccination in young people, especially males, communication strategies are needed to motivate adolescents to get themselves vaccinated. Texting has been demonstrated to be a feasible, popular, and effective method of sexual health promotion to young people with a relatively low withdrawal rate, positive feedback, and an observed improvement in sexual health knowledge and STI testing (12). Social media communication strategies are a new and potentially effective channel for communicating public health messages about HPV vaccine that are also likely to increase HPV initiation and completion among adolescent girls in addition to boys.
According to the NC Immunization Registry, as of March 8, 2011, only 2% of boys ages 9-13 had received at least one dose of HPV vaccine. In the investigators continuity clinic less than 50 percent of adolescents are fully immunized. This project will identify social behavioral, emotional, and cognitive correlates and predictors that help explain why teens pursue, complete, and do not complete HPV vaccination, and develop a social media communication intervention collaboratively with teens to increase HPV vaccine initiation and completion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social media | – | – |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescent males and females age 11-21 at a Pediatric clinic
Key inclusion criteria (1 listed)
- incomplete immunization
Key exclusion criteria (1 listed)
- complete immunization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HPV vaccination uptake
Time frame: 2 years
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 18 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.
Tamara Coyne-Beasley, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Immunizations Among Clinic Population, 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 18 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?
HPV vaccination uptake (time frame: 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 18 Apr 2017.