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An Intervention Promoting HPV Vaccination in Safety-net Clinics

NCT01729429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 831

Last updated 2020-03-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

HPV brochure, recall, reminders

* 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

General Adolescent Vaccine Brochure

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

Sponsors & Collaborators

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER

  • Parkland Health and Hospital System

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Jasmin A Tiro, PhD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01729429 on ClinicalTrials.gov