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
- 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
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
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
Jasmin A Tiro, PhD
UT Southwestern Medical Center
United States: Institutional Review Board
|Ut Southwestern Medical Center||Dallas, Texas 75390|
|Parkland Health & Hospital System||Dallas, Texas 75235|