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Facilitating Completion of HPV Vaccination

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ClinicalTrials.gov Identifier: NCT01600560
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date May 15, 2012
First Posted Date May 17, 2012
Last Update Posted Date April 18, 2017
Actual Study Start Date May 2012
Actual Primary Completion Date November 9, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2012)
HPV vaccination uptake [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01600560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Facilitating Completion of HPV Vaccination
Official Title Facilitating the Completion of the 3-Dose Series of HPV Vaccination in Males and Females
Brief 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. 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adolescent males and females age 11-21 at a Pediatric clinic
Condition Adolescent Immunizations Among Clinic Population
Intervention Not Provided
Study Groups/Cohorts Social media
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 17, 2017)
223
Original Estimated Enrollment
 (submitted: May 16, 2012)
200
Actual Study Completion Date July 5, 2016
Actual Primary Completion Date November 9, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • incomplete immunization

Exclusion Criteria:

  • complete immunization
Sex/Gender
Sexes Eligible for Study: All
Ages 11 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01600560
Other Study ID Numbers 11-1551
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor University of North Carolina, Chapel Hill
Collaborators Not Provided
Investigators
Principal Investigator: Tamara Coyne-Beasley, MD, MPH University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date April 2017