An Intervention Promoting HPV Vaccination in Safety-net Clinics

NCT01729429 | Completed

• 1 other identifier: PP100047
• Study Type: interventional
• Target: 831
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Human Papilloma Virus-Related Cervical Carcinoma

Keywords

Papillomavirus Vaccines; Intervention Studies; Health Services Research; Cancer of Cervix

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

General Adolescent Vaccine Brochure

ACTIVE COMPARATOR

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

Behavioral: General Adolescent Vaccine Brochure

HPV brochure, recall, reminders

EXPERIMENTAL

* 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

Behavioral: HPV brochure, recall, reminders

Interventions

HPV brochure, recall, reminders BEHAVIORAL

* 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 brochure, recall, reminders

General Adolescent Vaccine Brochure BEHAVIORAL

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

General Adolescent Vaccine Brochure

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• year old female patients and their parent
• Patient has an upcoming appointment at one of four Parkland clinics
• Patient has not initiated the HPV vaccine series

You may not qualify if:

• Adolescent patient was currently pregnant
• Parent Participated in Phase 1 Cognitive Interviews
• Sibling already enrolled in study
• Parent opted out or was not interested in the study
• Parent did not have a working address

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Cancer Prevention Research Institute of Texas: collaborator
• Parkland Health and Hospital System: collaborator

Study Sites (2)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 26482674 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jasmin A Tiro, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 20, 2012
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

US (2)