NCT01729429|Completed
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Sponsor study identifier
interventional
831
1 country
2
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)Study Completion
November 2012
Actual (reported)This randomized controlled trial is designed to evaluate whether a behavioral intervention that includes three components: 1) reminder letters and education materials delivered before the clinic visit, 2) telephone recalls after the visit for those who originally decline the vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1 and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls attending four Parkland primary care clinics in Dallas county. Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the Intervention group than those in the General Adolescent Vaccine Brochure group. Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among patients in the Intervention group who initially declined the vaccine than those in the General Adolescent Vaccine Brochure group who initially declined. Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among the Intervention group than those in the General Adolescent Vaccine Brochure group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
November 2012
Actual (reported)November 2012
Actual (reported)November 13, 2012
Actual (reported)November 20, 2012
Actual (reported)1 Dose Coverage of the HPV vaccine series at End of Study Period
Receipt of 1 or more doses of the HPV vaccine during 12-month study period
12 months
3 Dose Coverage of the HPV vaccine series at End of Study Period
Receipt of 3 doses of the HPV vaccine during the 12 month study period
12 months
Participants were mailed a brochure describing the 4 recommended adolescent vaccines (HPV, meningococcal, tetanus diptheria acellular pertussis (TDAP), and influenza) 1-2 weeks before a clinic visit
* HPV-vaccine specific brochure mailed before clinic visit * Telephone recalls after visit for those who complete pre-clinic survey and decline the vaccine * Telephone reminders for those who complete the pre-clinic survey and are late for receiving the 2nd and/or 3 doses
* HPV-vaccine specific brochure mailed before clinic visit * Telephone recalls after visit for those who complete pre-clinic survey and decline the vaccine * Telephone reminders for those who complete the pre-clinic survey and are late for receiving the 2nd and/or 3 doses
Participants were mailed a brochure describing the 4 recommended adolescent vaccines (HPV, meningococcal, tetanus diptheria acellular pertussis (TDAP), and influenza) 1-2 weeks before a clinic visit
Parkland Health & Hospital System
Dallas, Texas, 75235, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Tiro JA, Sanders JM, Pruitt SL, Stevens CF, Skinner CS, Bishop WP, Fuller S, Persaud D. Promoting HPV Vaccination in Safety-Net Clinics: A Randomized Trial. Pediatrics. 2015 Nov;136(5):850-9. doi: 10.1542/peds.2015-1563. Epub 2015 Oct 19.
Jasmin A Tiro, PhD
University of Texas Southwestern Medical Center
831 participants (actual enrollment reported by the registry).
First Submitted
November 13, 2012
First Posted
November 20, 2012
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2012
Actual (reported)Study Completion
November 2012
Actual (reported)Last Updated
March 18, 2020
Record last verified: 2020-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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