Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04380623 |
| Other study ID # |
18-12-890 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2021 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
September 2021 |
| Source |
Meharry Medical College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The human papillomavirus (HPV) causes 90% of cervical cancers and is implicated in multiple
other cancers. The HPV vaccine can prevent the vast majority of these cancers, but it is
underused in adolescents, especially among those within vaccine hesitant (VH) parents. The
proposed research is to develop and pilot test a tailored, health communication intervention
aimed to increase HPV vaccination among VH parents. The proposed research is innovative
because no evidence-based health communication interventions target HPV VH parents, and we
will use stakeholder engagement throughout this study. The research will add knowledge on how
tailored education provided before a doctor's visit can play a role in improving HPV
vaccination rates among underserved, VH parents.
Description:
The goal of this K01 application is to develop and pilot test an individually tailored,
pre-visit health communication intervention targeting HPV-VH parents. The partnering clinic
is Meharry Medical College Pediatric Group (MMC Pediatrics), a safety-net clinic serving
primarily publicly-insured and uninsured patients. The study has three specific aims.
Aim 1. To develop a tailored, health communication intervention targeting HPV-VH parents
prior to clinic visits. The tailored intervention will be delivered to VH parents via mobile
phones. Investigators will draft initial content based on the Theory of Reasoned Action and
Health Belief Model, previous VH research,14 and preliminary data. Then semi-structured
interviews will be conducted with 25-30 VH parents who previously declined the HPV vaccine
and 10 physicians to elicit feedback on draft content. Qualitative data will be collected and
analyzed iteratively, informing successive modifications to the intervention to cover a range
of potential concerns for VH parents, enhance message relevance, and refine the intervention
delivery process. Next, investigators will work with MMC Pediatrics to develop and refine the
study protocol. Investigators will pre-test and get feedback on the protocol from 16 VH
parents and 3 physicians to maximize acceptance and feasibility.
Aim 2. Conduct a pilot study of the intervention and study protocol to demonstrate
feasibility for the future full-scale randomized control trial (RCT). Based on Aim 1,
investigators will conduct a small, pilot RCT with 70 VH parents with scheduled clinic
visits. Feasibility indicators are recruitment rates, retention rates, and ability to
ascertain patients' post-visit HPV vaccine status in the clinical record. VHealth software
will be used to extract information from the EHR to identify potentially eligible patients
with a previous HPV vaccine refusal and to determine the whether an HPV vaccine dose was
received during the scheduled visit.
Aim 3. Examine acceptability of the intervention and protocol among parents and providers.
Parents participating in the pilot study will complete a post-visit survey to measure
acceptability of the intervention and protocol, provider trust/rapport, and satisfaction with
provider-patient communication. In addition, investigators will conduct semi-structured
debriefing interviews with a subset of 20-30 parents and 3 providers to gather qualitative
data about their experiences (e.g., unforeseen problems and barriers) and their perceptions
of acceptability of the intervention and protocol (e.g., ease of use, content, graphics). The
findings will be used identify needs for any additional modifications to the intervention and
protocol prior to the RCT.
