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An Intervention Promoting HPV Vaccination in Safety-net Clinics


N/A
11 Years
18 Years
Not Enrolling
Female
Human Papilloma Virus-Related Cervical Carcinoma

Thank you

Trial Information

An Intervention Promoting HPV Vaccination in Safety-net Clinics


The primary research goal is to implement and evaluate evidence-based intervention
strategies targeted to adolescent girls and their parents that stimulate patient demand for
the human papillomavirus (HPV) vaccine and compliment provider-directed strategies already
employed by Parkland clinics.

The project has three specific aims:

- Aim 1. Determine if a mailed packet with a reminder and educational material delivered
prior to clinic visit, increases 1 dose coverage of the HPV vaccine series.

- Aim 2. Determine if a telephone recall delivered 2 weeks after the clinic visit,
increases 1 dose coverage among patients who decline the vaccine during the clinic
visit.

- Aim 3. Determine if telephone recalls to those who miss appointments for 2nd or 3rd
doses of the HPV vaccine series, increase 3 dose coverage of the series.

Phase 1 - Cognitive interviews: To ensure the usability and cultural appropriateness of all
project materials, investigators will conduct 40 in-person, cognitive interviews with
parents of female patients ages 11-18 attending Parkland clinics.

Phase 2 - Randomized controlled trial. Investigators will select and invite 1200 families
whose daughter has an upcoming appointment at one of four Parkland clinic sites. Eligible
patients will be randomized to either the Intervention group or the General Adolescent
Vaccine Brochure group. The Intervention group participants will be mailed a packet
containing an invitation letter to join the study and HPV vaccine-specific educational
materials; General Adolescent Vaccine Brochure group participants will be mailed a packet
with educational materials on all four of the recommended adolescent vaccines (HPV,
meningococcal, TDAP, and influenza). A few days after the packet has been sent, a research
assistant will call participants to verify that the letter was received and assess interest
in completing a pre-clinic visit survey.

Participants who agree to fill out the in-clinic survey will be asked to come to their
clinic appointment 40 minutes early to obtain verbal informed consent from the parent and
verbal assent from the adolescent female patient. Then, the parent will complete a 20-30
minute survey about the HPV vaccine and interactions with their daughter's provider. The
daughter will complete a short survey that asks about use of social media and health
concerns.

Intervention group participants who complete the in-clinic survey are also eligible to
receive telephone recalls and reminders. If the Intervention group parent refused the
vaccine during the initial clinic visit, a telephone recall will be delivered after 2 weeks
offering to schedule an immunization-only appointment. If the Intervention group participant
misses the 2nd and/or 3rd doses, telephone reminders will be delivered. For participants who
complete the in-clinic survey and are randomized to the General Adolescent Vaccine Brochure
group, parents who refused will be contacted after 2 weeks to assess attitudes and
intentions toward the HPV vaccine.

Participants in both the Intervention and General Adolescent Vaccine Brochure group will
have their medical record reviewed to assess HPV vaccine outcomes, receipt of the other
three recommended adolescent vaccines, and contact with the clinic during the 12 months
following randomization.


Inclusion Criteria:



- 11-18 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Outcome Measure:

1 Dose Coverage of the HPV vaccine series at End of Study Period

Outcome Description:

Receipt of 1 or more doses of the HPV vaccine during 12-month study period

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Jasmin A Tiro, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT Southwestern Medical Center

Authority:

United States: Institutional Review Board

Study ID:

PP100047

NCT ID:

NCT01729429

Start Date:

May 2010

Completion Date:

November 2012

Related Keywords:

  • Human Papilloma Virus-Related Cervical Carcinoma
  • Papillomavirus Vaccines
  • Intervention Studies
  • Health Services Research
  • Cancer of Cervix
  • Carcinoma
  • Papilloma
  • Uterine Cervical Neoplasms

Name

Location

Ut Southwestern Medical CenterDallas, Texas  75390
Parkland Health & Hospital SystemDallas, Texas  75235