Developing a self-persuasion intervention promoting adolescent HPV vaccination

Study ID
STU 022013-016

Cancer Related
Yes

Healthy Volunteers
Yes

Study Sites

Contact
Emily Marks
214-456-6526
emily.marks@utsouthwestern.edu

Principal Investigator
Jasmin Tiro

Summary

This 3-stage trial will develop a parent-targeted intervention for HPV vaccination in 11-17 year old girls and boys attending Parkland clinics. Drs. Tiro and Persaud will work with eMR programmers to identify parent-child dyads meeting eligibility criteria. We are requesting a HiPaa waiver of privacy authorization for research to verify the adolescent's vaccination status prior to contacting the parent, as well as examine visit history data to ascertain recruitment clinic/provider. Parents will be mailed an invitation letter. Parents who have not refused contact will be called by a bilingual research assistant (Ra) who invite the parent to participate. if interested, the Ra will verify eligibility and arrange an in-person meeting. Ras will verbally consent eligible parents and administer a baseline survey. Prior to Stage 1a, we will conduct 16 cognitive testing interviews of the surveys using the same recruitment procedures as Stage 1a, however we will also recruit participants from the Community Research Registry.
Stage 1. aim 1a: We will recruit 42 parents of unvaccinated adolescents and 11 parents of adolescents who initiated the series. Parents will use a tablet-based application. The Ra will use a series of questions to prompt parents to verbalize pro-vaccine arguments. Parents will then be asked to listen to, rate, and choose among peer-generated arguments. We will use probes to determine whether they can distinguish among and select their preferred arguments.
in partnership with Dr. Donna Persaud, a co-investigator on this project and in preparation for our large scale efficacy trial, we will to analyze a subset of our existing data for Stage 1a of our project. using our existing data, we will analyze the patterns of HPV vaccine dosing and adherence for 11-17 year old patients and stratify by race/ethnicity and sex.
aim 1b: We will recruit 53 parents of unvaccinated adolescents with upcoming clinic appointments. We will audiorecord parent-provider discussions. afterwards, parents will be asked about their prior experience with this provider and whether the HPV vaccine was discussed during the visit. The Ra will administer a survey about provider recommendations, HPV vaccine benefits/barriers, and perceived involvement in medical care.
Stage 2. aim 2: We will randomly assign 168 undecided parents to 1 of 4 intervention conditions. Parents will use a tablet-based application to either verbalize their own arguments based on topics they choose (deep processing/high choice), verbalize arguments based on topics assigned to them (deep processing/low choice), listen to arguments based on topics they choose (shallow processing/high choice), or listen to arguments based on topics assigned to them (shallow processing/low choice). We will assess parents' perspective on the tablet application, self-persuasion condition, and how their beliefs/experiences shape feelings about the HPV vaccine. adolescents who accompany their parents to the appointment at their Parkland clinic will be offered the 1st HPV vaccine dose from a Parkland nurse immediately after the exit interview.
Stage 3. aim 3: Parents will be randomly assigned to either self-persuasion plus information (aim 2 optimal intervention condition; n[?]48), or HPV information only (n[?]47). For the self-persuasion group, we will follow procedures in Stage 1. Parents in the info-only group will be given a tablet and instructed to listen to information about HPV infections and the benefits/risks of the HPV vaccine. We will audiorecord the parent-provider discussion. immediately after the visit, participants will be asked questions about their experiences using the tablet and their communication with the provider.

Participant Eligibility

1) Parent of an adolescent child 11-17 years old
2) Adolescent has visited the clinic in past 18 months (with the exception of Community Research Registry participants)
3) Adolescent has not started HPV vaccine series (with the exception of Aim 1 cognitive interviews with 11 parents who have been immunized to capture the full range of pro-vaccine arguments)
4) Parent undecided about the vaccine