Cervical CancerNCT03856437
A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination
A study testing HPV vaccination messages in people with Cervical Cancer and Anal Cancer, run by University of Maryland, College Park at 1 site in United States.
Trial summary
The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Anal Cancer, Penile Cancer
- What is being tested?
- HPV vaccination messages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,170 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Self-identify as African American
- Custodial parent or caretaker of at least one child under the age of 18 who has not been fully vaccinated against HPV.
- Has access to Internet to complete the study
Who cannot join
- Younger than 18 years
- Does not self-identify as African American
- Not a custodial parent or caretaker of at least one child under the age of 18 who has not been fully vaccinated against HPV.
- Has no access to Internet to complete the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland
College Park, Maryland, 20742
About this study
The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants are randomized into gain and loss conditions in which they view either gain-framed or loss-framed HPV vaccination messages. Key outcome variables include parents' attitudes and intentions toward vaccinating their children against HPV.
Read the detailed description
The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants recruited from local communities and online panels will complete a computer-assisted survey. In the survey participants will first answer questions related to their beliefs about HPV and the HPV vaccine (e.g., perceived susceptibility, perceived severity, perceived efficacy, perceived safety, etc.), as well as other background information. Then they will be presented with either a gain-framed or loss-framed human papillomavirus vaccination message. After the message exposure, they will answer questions related to their attitudes toward HPV vaccination, intentions to vaccinate their children, as well as other message response measures. Eligible participants are at least 21 years old, self-identify as African American, and are custodial parents or caretakers of at least one child ages 9-17 who has not initiated the HPV vaccine series.
- Conditions
- Cervical Cancer, Anal Cancer, Penile Cancer
- Being tested
- HPV vaccination messages
- Medical subject headings
- Uterine Cervical Neoplasms, Anus Neoplasms, Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccination messagesBehavioural
Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV, the costs of not being vaccinated against HPV, or neither benefits or costs but simply a call for action.
| Study group | Role | What they receive |
|---|---|---|
| Gain-framed messages | Experimental | Participants in this arm receive gain-framed HPV vaccination messages. Receives: Behavioral: HPV vaccination messages |
| Loss-framed messages | Experimental | Participants in this arm receive loss-framed HPV vaccination messages. Receives: Behavioral: HPV vaccination messages |
| Control messages | Active comparator | Participants in this arm receive non-framed HPV vaccination messages. Receives: Behavioral: HPV vaccination messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes
Attitudes toward HPV vaccination for children Scale range: 1-7 (higher score indicates more positive attitude) Subscales were averaged.
Measured: baseline posttest (test was approximately 5 minutes to complete)
Intention to Vaccinate Free of Cost
Intention to have children vaccinated against HPV free of cost Scale range: 1-6 (higher score indicates stronger intention) Subscales were averaged.
Measured: baseline posttest (test was approximately 5 minutes to complete)
Secondary outcomes (1)
Intention to Vaccinate With Cost
Intention to have children vaccinated against HPV free with cost Scale range: 1-6 (higher score indicates stronger intention) Subscales were averaged.
Measured: baseline posttest (test was approximately 5 minutes to complete)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start22 Jan 2021
- Primary completion25 Mar 2021
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies 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
- None (open label)
- Enrolment
- 1,170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Xiaoli Nan, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856437
- Sponsor's protocol ID
- 1322177-1.1
- Other IDs
- R01CA219060
- Status last verified
- Mar 2024
- First submitted
- 17 Dec 2018
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination
- ClinicalTrials.gov ID
- NCT03856437
- Acronym / sponsor ID
- 1322177-1.1
- Conditions
- Cervical Cancer, Anal Cancer, Penile Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,170 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Posted 15 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants are randomized into gain and loss conditions in which they view either gain-framed or loss-framed HPV vaccination messages. Key outcome variables include parents' attitudes and intentions toward vaccinating their children against HPV.
Detailed description
The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants recruited from local communities and online panels will complete a computer-assisted survey. In the survey participants will first answer questions related to their beliefs about HPV and the HPV vaccine (e.g., perceived susceptibility, perceived severity, perceived efficacy, perceived safety, etc.), as well as other background information. Then they will be presented with either a gain-framed or loss-framed human papillomavirus vaccination message. After the message exposure, they will answer questions related to their attitudes toward HPV vaccination, intentions to vaccinate their children, as well as other message response measures. Eligible participants are at least 21 years old, self-identify as African American, and are custodial parents or caretakers of at least one child ages 9-17 who has not initiated the HPV vaccine series.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gain-framed messages | Experimental | Behavioral: HPV vaccination messagesParticipants in this arm receive gain-framed HPV vaccination messages. |
| Loss-framed messages | Experimental | Behavioral: HPV vaccination messagesParticipants in this arm receive loss-framed HPV vaccination messages. |
| Control messages | Active comparator | Behavioral: HPV vaccination messagesParticipants in this arm receive non-framed HPV vaccination messages. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Self-identify as African American
- Custodial parent or caretaker of at least one child under the age of 18 who has not been fully vaccinated against HPV.
- Has access to Internet to complete the study
Key exclusion criteria (4 listed)
- Younger than 18 years
- Does not self-identify as African American
- Not a custodial parent or caretaker of at least one child under the age of 18 who has not been fully vaccinated against HPV.
- Has no access to Internet to complete the study
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 |
|---|---|---|
| HPV vaccination messagesDigital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV, the costs of not being vaccinated against HPV, or neither benefits or costs but simply a call for action. | Behavioural | Control messages, Gain-framed messages, Loss-framed messages |
Primary outcome
Attitudes
Time frame: baseline posttest (test was approximately 5 minutes to complete)
Attitudes toward HPV vaccination for children Scale range: 1-7 (higher score indicates more positive attitude) Subscales were averaged.
Intention to Vaccinate Free of Cost
Time frame: baseline posttest (test was approximately 5 minutes to complete)
Intention to have children vaccinated against HPV free of cost Scale range: 1-6 (higher score indicates stronger intention) Subscales were averaged.
1 secondary outcome
Intention to Vaccinate With Cost
Time frame: baseline posttest (test was approximately 5 minutes to complete)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Xiaoli Nan principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV vaccination messages in people with Cervical Cancer and Anal Cancer, run by University of Maryland, College Park 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 15 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attitudes (time frame: baseline posttest (test was approximately 5 minutes to complete)). The study lists 2 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 15 Mar 2024.