Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01729429 |
| Other study ID # |
PP100047 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2010 |
| Est. completion date |
November 2012 |
Study information
| Verified date |
March 2020 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 an invitation letter and educational material
(HPV-specific or general brochure about all recommended adolescent vaccines) 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 parent-patient dyads who decline the vaccine during the
clinic visit.
- Aim 3. Determine if telephone reminders to those overdue for Dose 2 or 3 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.
Ancillary Analyses
The investigators will perform stratified analyses and multivariate logistic regression
modeling to examine whether certain subgroups were more likely initiate and complete the
series (e.g, vaccine uptake might vary by characteristics such as preferred language,
race/ethnicity, patient age, or parent educational status). The Investigators will use
similar methods to also examine our data for confounding, for example, if initiation differs
by clinic site. If no interactions are found (e.g., outcome estimates are similar for
different subgroups), the investigators will report summary chi-square tests that only adjust
for potential confounders.
The investigators will also use the dates that patients received the 1st, 2nd, and 3rd HPV
doses to run a time-to-recurrent event analysis. The investigators will model the completion
of the 3-dose series as recurrent event data, 72; 73 with event times from intervention to
Dose 1, Dose 1 to 2, and Dose 2 to 3. A proportional means model will be constructed with the
outcome being the recurrent events, and the variables of interest including intervention
group assignment, sociodemographic, clinic site, knowledge, and attitudes. A significant
intervention indicator effect will conclude that the intervention generally shortens the time
between initiation and receipt of all doses.
Secondary Analyses
The investigators will conduct the following secondary analyses to evaluate whether parents
who receive the intervention have greater HPV vaccine knowledge, information seeking, and
PAPM stage progression compared to parents receiving usual care. Among those who consented
for additional contact and completed pre-clinic and follow-up surveys, the investigators will
explore associations among intervention assignment and intermediate factors including
parents' HPV vaccine knowledge, attitudes, perceived risk, information-seeking, and HPV
vaccine decisional stage. Descriptive statistics will be calculated and outliers identified.
A correlation matrix will be run to check for multicollinearity (strong correlations between
intermediate factors). The investigators will run univariate and multivariate logistic
regression models to determine whether intervention assignment is associated with greater
knowledge of the HPV vaccine, more positive attitudes toward and information seeking about
the HPV vaccine, and PAPM stage progression.
To explore generalizability to all safety-net patients in the clinics, the investigators will
compute t tests or chi-square tests and examine whether patients who 1) decline to
participate or 2) do not consent for reminder and recall intervention components differ from
those randomized with respect to variables available in the EMR (patient demographics, health
care utilization patterns, clinic visit characteristics).
