Human Papilloma VirusNCT04380623
A Tailored, Health Communication Intervention for HPV Vaccine Hesitant Families
A study testing Mobile Phone-Based Web-Page: HPV vaccine in people with Human Papilloma Virus and HPV-Related Carcinoma, run by Meharry Medical College at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, HPV-Related Carcinoma, Vaccine Refusal
- What is being tested?
- Mobile Phone-Based Web-Page: HPV vaccine
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents
- Parents of patients of MMC Pediatrics aged 11-18
- Refused HPV vaccination in the past two years
- Have not received any doses of HPV vaccine
- Own smartphone
- Speak English
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- Have a clinic appointment scheduled within the coming month (AIM 1 Stage 2 \& AIM 2 only)
- Did not participate in Aim 1 Stage 1 (AIM 1 Stage 2 only)
- Did not participate in Aim 1 Stage 1 or Aim 1 Stage 2 (Aim 2 only)
- Providers
- Physicians, physician assistants, and nurse practitioners who deliver primary care to patients aged 11-18 (Aim 1 Stage 1)
- Physicians, physician assistants, and nurse practitioners who deliver primary care to patients aged 11-18 and the intervention at Meharry Medical College. (Aim 1 Stage 2, Aim 2)
Who cannot join
- Parents
- Parents with vaccinated patients or never been offered the vaccine in MMC pediatrics aged 11-18
- Unvaccinated yet never refused the vaccine
- Do not speak English
- Do not own a smart phone
- Does not have an upcoming clinic visit (Aim 1 Stage 2 and Aim 2)
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- Providers
- Providers: Physicians, nurse practitioners, and physician assistants who do not deliver primary care to pediatric patients aged 11-18 at Meharry and other clinics
- Providers who do not provide the HPV vaccine.
- Providers who do not participate in Aim 1 stage 1 (Aim 1 Stage 2 only)
- Did not pilot study (Aim 2)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Meharry Medical College
Nashville, Tennessee, 37208
Jennifer C Erves, PhD, 6153275692, jerves@mmc.edu
Kimberly Thomas, RN, CCRP, LNC, 615-327-6735, kthomas@mmc.edu
About this study
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.
Read the detailed 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.
- Conditions
- Human Papilloma Virus, HPV-Related Carcinoma, Vaccine Refusal, Parents, Program, Communication
- Being tested
- Mobile Phone-Based Web-Page: HPV vaccine
- Medical subject headings
- Vaccination Refusal, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Phone-Based Web-Page: HPV vaccineBehavioural
Website to be accessed via mobile phone to deliver tailored educational material
| Study group | Role | What they receive |
|---|---|---|
| Mobile Phone-Based Web-Page: HPV vaccine | Experimental | Parents who have already declined the HPV vaccine for their adolescent will receive pre-visit, tailored education information on the HPV vaccine via a text message with a website link. Receives: Behavioral: Mobile Phone-Based Web-Page: HPV vaccine |
| Mobile Phone-Based Web-Page: Healthy Lifestyles | Active comparator | Parents who have already declined the HPV vaccine for their adolescent will receive pre-visit education information on an unrelated topic (e.g., healthy eating and physical activity) via a text message with a website link. Receives: Behavioral: Mobile Phone-Based Web-Page: HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rates
pre-screened, % contacted, % unable to contact, % screened, % enrolled, # enrolled per month
Measured: 6 months
Retention Rates
% completed baseline survey, % came to clinic visit (primary retention endpoint), % completed post-visit survey
Measured: 6 months
Data collection processes
% ascertained post-visit HPV vaccine status, # minutes to complete surveys
Measured: 6 months
Secondary outcomes (1)
HPV vaccine rates
# vaccinated post-intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start15 Feb 2021
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380623
- Sponsor's protocol ID
- 18-12-890
- Status last verified
- Sep 2021
- First submitted
- 5 May 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored, Health Communication Intervention for HPV Vaccine Hesitant Families
- ClinicalTrials.gov ID
- NCT04380623
- Acronym / sponsor ID
- 18-12-890
- Conditions
- Human Papilloma Virus, HPV-Related Carcinoma, Vaccine Refusal, Parents, Program, Communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Phone-Based Web-Page: HPV vaccine | Experimental | Behavioral: Mobile Phone-Based Web-Page: HPV vaccineParents who have already declined the HPV vaccine for their adolescent will receive pre-visit, tailored education information on the HPV vaccine via a text message with a website link. |
| Mobile Phone-Based Web-Page: Healthy Lifestyles | Active comparator | Behavioral: Mobile Phone-Based Web-Page: HPV vaccineParents who have already declined the HPV vaccine for their adolescent will receive pre-visit education information on an unrelated topic (e.g., healthy eating and physical activity) via a text message with a website link. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Parents
- Parents of patients of MMC Pediatrics aged 11-18
- Refused HPV vaccination in the past two years
- Have not received any doses of HPV vaccine
- Own smartphone
Key exclusion criteria (11 listed)
- Parents
- Parents with vaccinated patients or never been offered the vaccine in MMC pediatrics aged 11-18
- Unvaccinated yet never refused the vaccine
- Do not speak English
- Do not own a smart phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Phone-Based Web-Page: HPV vaccineWebsite to be accessed via mobile phone to deliver tailored educational material | Behavioural | Mobile Phone-Based Web-Page: HPV vaccine, Mobile Phone-Based Web-Page: Healthy Lifestyles |
Primary outcome
Recruitment Rates
Time frame: 6 months
pre-screened, % contacted, % unable to contact, % screened, % enrolled, # enrolled per month
Retention Rates
Time frame: 6 months
% completed baseline survey, % came to clinic visit (primary retention endpoint), % completed post-visit survey
Data collection processes
Time frame: 6 months
% ascertained post-visit HPV vaccine status, # minutes to complete surveys
1 secondary outcome
HPV vaccine rates
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Phone-Based Web-Page: HPV vaccine in people with Human Papilloma Virus and HPV-Related Carcinoma, run by Meharry Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.