An Intervention Promoting HPV Vaccination in Safety-net Clinics
This trial is designed to evaluate whether an intervention that includes reminder letters and amp; education materials delivered before the clinic visit, telephone recalls after the visit for those who decline the vaccine, and amp; telephone recalls for those who schedule but miss immunization appointments, increases initiation and amp; completion of the HPV vaccine series among 11-18 year old females attending four Parkland clinics. Phase 1 Cognitive interviews: To ensure usability and cultural appropriateness of project materials, we will conduct 40 in-person, cognitive interviews with parents of female patients ages 11-18 attending Parkland. Families that participate in the cognitive interview will be excluded from the RCT. Phase 2 Randomized controlled trial: To achieve Specific Aims 1-4, research subjects will be female patients 11-18 years old and amp; their parents. We will randomly contact 1200 families whose daughter has an upcoming appointment. Prior to contact we will review their medical record to verify that the daughter has not yet begun the HPV vaccine series. We are requesting a waiver of HIPAA privacy authorization for research to verify vaccination status. Eligible candidates will be mailed a packet containing a study invitation letter and educational materials. A few days later, an RA will call potential participants to assess interest. Participants who agree to fill out the in-clinic survey will be asked to come to their appointment 40 minutes early to obtain verbal informed consent from the parent and amp; verbal assent from the adolescent patient. The parent will complete a 20-30 minute survey about the HPV vaccine and amp; interactions with the provider. The daughter will complete a short survey about social media use and amp; health concerns. A randomly selected group will receive the 3-part intervention (mailed educational materials, telephone recalls to those who refuse the vaccine during the initial appointment, and amp; telephone recalls to those who miss the 2nd/3rd doses) and the other group will receive usual care (mailed CDC handout on all recommended adolescent vaccines). Patients in both groups will have their medical record reviewed 12 months after the clinic visit to assess the primary outcomes of HPV vaccine initiation and amp; completion. Aim1:To test the effect of mailed educational materials for all patients who received these materials, we are requesting a waiver of HIPAA authorization to review the medical records of patients who received the mailed educational, did not opt out, and amp; did not complete the survey. Patients/parents can opt out of the study either by calling the number provided in the invitation letter or during the invitation call. We will not review the records of patients whose mailed invitation packet was returned due to an incorrect/undeliverable address. We expect to review the records of 395 patients who received educational materials but did not complete the survey. We will review their record: 1) upon approval of the waiver of HIPAA authorization to determine HPV vaccine initiation status after study index visit; 2) 12 months after the index visit to determine if the vaccine series was completed. During the review, we will also abstract information for 3 other vaccines (TDAP, MCV4, and amp; influenza) that are correlated with HPV vaccination. In order to determine if there were missed opportunities for vaccine administration, we will also extract dates for al
Phase 1 – Cognitive Interviews: Parents of female patients (11-18 years old) at DeHaro Saldivar, East Dallas, or Oarkwest outreach clinics will be considered eligible for the cognitive interviews.
Phase 2 – Randomized Controlled Trial: Female patients (11-18 years old) who have an upcoming appointment at DeHaro Saldivar, East Dallas, or Oarkwest outreach clinics and have not initiated the HPV vaccine series (and their parents) will be considered eligible.