Behavior, Information SeekingNCT05206669
Testing Messages to Promote HPV Vaccination
A study testing Health Messages in people with Behavior, Information Seeking and Intention, run by University of Colorado, Denver.
Trial summary
Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Hispanic women have the highest rates of HPV-related cervical cancer compared to all other groups in the U.S. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Information Seeking, Intention, Vaccine Hesitancy
- What is being tested?
- Health Messages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 784 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2016to 5 Mar 2017
- 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
- For parents eligibility criteria were being: 1) of Hispanic or Latino origin, 2) 18 years or older, 3) a parent or guardian of a child ages 11-17 who had not been vaccinated for HPV.
- For young adults eligibility were being: 1) of Hispanic or Latino origin, 2) 18-26 years of age (vaccine eligibility at the time of data collection, and 3) having not been vaccinated for HPV.
Who cannot join
- Being under 18 years of age
- Not identifying as Hispanic or Latino
- For parents, having no children ages 11-17 or having only children already vaccinated for HPV
- For young adults, having already been vaccinated for HPV or no longer being eligible due to age (>26)
About this study
Official title: TESTING MESSAGES TO PROMOTE USE OF AN HPV ONLINE INTERVENTION
Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Hispanic women have the highest rates of HPV-related cervical cancer compared to all other groups in the U.S. Previous research has delineated several unique barriers to HPV vaccination among Hispanic women, suggesting that interventions that focus on addressing these barriers may improve HPV vaccination compliance in this population. To address some of these unique barriers, an online tailored messaging intervention was developed and tested. Initial analyses demonstrate that participants exposed to an online intervention demonstrated higher intentions to vaccinate for HPV after viewing the informational materials. The next phase of the project will be comprised of promoting use of the online intervention to the general public through the use of theory-based, pretested messages delivered via advertisements on Facebook and Twitter. Specifically, messages will be targeted based on differences between Hispanic parents of adolescents and Hispanic young adults. Previous research has explored the use of the Extended Parallel Processing Model as a theory to guide messages designed to promote health behaviors. The current study extends this work in the area of HPV prevention. Specifically, it seeks to examine the use of this theory as a means to stimulate information seeking behavior in the form of use of the previously developed online intervention that provides information about HPV. We also hope to make a significant contribution to research demonstrating the importance of targeting messages based on differences in population characteristics. Additionally, this study seeks to build on research examining the use of social media sites as a means for implementing health interventions and promoting positive health outcomes. Ultimately, the current study seeks to improve both the HPV vaccination decision-making process and HPV vaccination rates. If this was achieved among the Hispanic population it could substantially decrease disparities in cervical cancer and other HPV-related diseases.
- Conditions
- Behavior, Information Seeking, Intention, Vaccine Hesitancy
- Being tested
- Health Messages
- Keywords
- HPV vaccine, Vaccine intention
- Medical subject headings
- Information Seeking Behavior, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health MessagesBehavioural
Brief messages providing information about the effectiveness of HPV vaccines. Messages included embedded links where participants could find more information.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Messages - Young Adults | Experimental | Messages providing information about the use of HPV vaccines to prevent cancer. Receives: Behavioral: Health Messages |
| Cancer Messages - Parents of Adolescents | Experimental | Messages providing information about the use of HPV vaccines for their adolescent children to prevent cancer. Receives: Behavioral: Health Messages |
| Genital Wart Messages - Young Adults | Experimental | Messages providing information about the use of HPV vaccines to prevent genital warts. Receives: Behavioral: Health Messages |
| Genital Wart Messages - Parents of Adolescents | Experimental | Messages providing information about the use of HPV vaccines or their adolescent children to prevent genital warts. Receives: Behavioral: Health Messages |
| Control Messages - Young Adults | Active comparator | Messages providing information about HPV vaccines that did not mention prevention of other diseases or conditions. Receives: Behavioral: Health Messages |
| Control Messages - Parents of Adolescents | Active comparator | Messages providing information about HPV vaccines for their adolescent children that did not mention prevention of other diseases or conditions. Receives: Behavioral: Health Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to Seek Information - 1
Hyperlinks were embedded in intervention messages where participants were told they could find more information about HPV. A click on the link was considered intention to seek information. Not clicking on the link was considered no intention to seek information.
Measured: 1 day (one time while participants viewed the brief intervention.)
Intention to Seek Information - 2
Intention to Seek Information survey items measure participants likelihood to seek information about HPV. Survey items included a Yes-No response to the statement "I intend to look for more information about the HPV vaccination within the next 30 days." Those who answer "Yes" were then shown a series of questions prompting them to indicate their likelihood of seeking more information about the HPV vaccination from their "doctor or healthcare provider," "a friend of family member," "the Internet," and "other sources." Responses were measured on a 7-point Likert-type scale that ranged from Very Likely to Very Unlikely. Those who answered "No" were shown the question "Which of the following best represents your reason for not seeking information about the HPV vaccine?". Responses included 1) low interest in the topic, 2) already well informed on the topic, 3) topic is not relevant to me, and 4) information on this topic is upsetting to me.
Measured: Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention.
Secondary outcomes (1)
Intention to Vaccinate for HPV
Intention to Vaccinate for HPV measures participants willingness to vaccinate for HPV. It was measured using a single item stating "I intend to get vaccinated against HPV within the next 6 months." Reponses were measured on a 7-point scale ranging from "Strongly agree" to "Strongly disagree."
Measured: Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start18 Nov 2016
- Primary completion5 Mar 2017
- Study completion5 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior, Information SeekingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- The current study employed a 2 x 3 mixed factorial design. Participants consisted of two groups: 1) Hispanic or Latino parents of adolescents (age 11-17), and 2) Hispanic or Latino young adults (age 18-26). Participants were randomly assigned to one of three message conditions: cancer, genital warts, or control messages.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206669
- Sponsor's protocol ID
- 16-0447
- Status last verified
- Jan 2022
- First submitted
- 17 Dec 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reno JE, Dempsey AF. Promoting HPV vaccination among Latinx: an application of the extended parallel processing model. J Behav Med. 2023 Apr;46(1-2):324-334. doi: 10.1007/s10865-022-00293-7. Epub 2022 Feb 18.
PubMed 35178652
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TESTING MESSAGES TO PROMOTE USE OF AN HPV ONLINE INTERVENTION
- ClinicalTrials.gov ID
- NCT05206669
- Acronym / sponsor ID
- 16-0447
- Conditions
- Behavior, Information Seeking, Intention, Vaccine Hesitancy
- Keywords
- HPV vaccine, Vaccine intention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 5 Mar 2017 (actual)
- Study completion
- 5 Mar 2017 (actual)
- First posted
- 25 Jan 2022 (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.
Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Hispanic women have the highest rates of HPV-related cervical cancer compared to all other groups in the U.S. Previous research has delineated several unique barriers to HPV vaccination among Hispanic women, suggesting that interventions that focus on addressing these barriers may improve HPV vaccination compliance in this population. To address some of these unique barriers, an online tailored messaging intervention was developed and tested. Initial analyses demonstrate that participants exposed to an online intervention demonstrated higher intentions to vaccinate for HPV after viewing the informational materials. The next phase of the project will be comprised of promoting use of the online intervention to the general public through the use of theory-based, pretested messages delivered via advertisements on Facebook and Twitter. Specifically, messages will be targeted based on differences between Hispanic parents of adolescents and Hispanic young adults. Previous research has explored the use of the Extended Parallel Processing Model as a theory to guide messages designed to promote health behaviors. The current study extends this work in the area of HPV prevention. Specifically, it seeks to examine the use of this theory as a means to stimulate information seeking behavior in the form of use of the previously developed online intervention that provides information about HPV. We also hope to make a significant contribution to research demonstrating the importance of targeting messages based on differences in population characteristics. Additionally, this study seeks to build on research examining the use of social media sites as a means for implementing health interventions and promoting positive health outcomes. Ultimately, the current study seeks to improve both the HPV vaccination decision-making process and HPV vaccination rates. If this was achieved among the Hispanic population it could substantially decrease disparities in cervical cancer and other HPV-related diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- The current study employed a 2 x 3 mixed factorial design. Participants consisted of two groups: 1) Hispanic or Latino parents of adolescents (age 11-17), and 2) Hispanic or Latino young adults (age 18-26). Participants were randomly assigned to one of three message conditions: cancer, genital warts, or control messages.
| Arm | Type | Receives |
|---|---|---|
| Cancer Messages - Young Adults | Experimental | Behavioral: Health MessagesMessages providing information about the use of HPV vaccines to prevent cancer. |
| Cancer Messages - Parents of Adolescents | Experimental | Behavioral: Health MessagesMessages providing information about the use of HPV vaccines for their adolescent children to prevent cancer. |
| Genital Wart Messages - Young Adults | Experimental | Behavioral: Health MessagesMessages providing information about the use of HPV vaccines to prevent genital warts. |
| Genital Wart Messages - Parents of Adolescents | Experimental | Behavioral: Health MessagesMessages providing information about the use of HPV vaccines or their adolescent children to prevent genital warts. |
| Control Messages - Young Adults | Active comparator | Behavioral: Health MessagesMessages providing information about HPV vaccines that did not mention prevention of other diseases or conditions. |
| Control Messages - Parents of Adolescents | Active comparator | Behavioral: Health MessagesMessages providing information about HPV vaccines for their adolescent children that did not mention prevention of other diseases or conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For parents eligibility criteria were being: 1) of Hispanic or Latino origin, 2) 18 years or older, 3) a parent or guardian of a child ages 11-17 who had not been vaccinated for HPV.
- For young adults eligibility were being: 1) of Hispanic or Latino origin, 2) 18-26 years of age (vaccine eligibility at the time of data collection, and 3) having not been vaccinated for HPV.
Key exclusion criteria (4 listed)
- Being under 18 years of age
- Not identifying as Hispanic or Latino
- For parents, having no children ages 11-17 or having only children already vaccinated for HPV
- For young adults, having already been vaccinated for HPV or no longer being eligible due to age (>26)
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 |
|---|---|---|
| Health MessagesBrief messages providing information about the effectiveness of HPV vaccines. Messages included embedded links where participants could find more information. | Behavioural | Cancer Messages - Parents of Adolescents, Cancer Messages - Young Adults, Control Messages - Parents of Adolescents, Control Messages - Young Adults, Genital Wart Messages - Parents of Adolescents, Genital Wart Messages - Young Adults |
Primary outcome
Intention to Seek Information - 1
Time frame: 1 day (one time while participants viewed the brief intervention.)
Hyperlinks were embedded in intervention messages where participants were told they could find more information about HPV. A click on the link was considered intention to seek information. Not clicking on the link was considered no intention to seek information.
Intention to Seek Information - 2
Time frame: Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention.
Intention to Seek Information survey items measure participants likelihood to seek information about HPV. Survey items included a Yes-No response to the statement "I intend to look for more information about the HPV vaccination within the next 30 days." Those who answer "Yes" were then shown a series of questions prompting them to indicate their likelihood of seeking more information about the HPV vaccination from their "doctor or healthcare provider," "a friend of family member," "the Internet," and "other sources." Responses were measured on a 7-point Likert-type scale that ranged from Very Likely to Very Unlikely. Those who answered "No" were shown the question "Which of the following best represents your reason for not seeking information about the HPV vaccine?". Responses included 1) low interest in the topic, 2) already well informed on the topic, 3) topic is not relevant to me, and 4) information on this topic is upsetting to me.
1 secondary outcome
Intention to Vaccinate for HPV
Time frame: Outcome was measured one time immediately post-intervention via the post-survey items described to assess their degree of intention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 35178652Reno JE, Dempsey AF. Promoting HPV vaccination among Latinx: an application of the extended parallel processing model. J Behav Med. 2023 Apr;46(1-2):324-334. doi: 10.1007/s10865-022-00293-7. Epub 2022 Feb 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Health Messages in people with Behavior, Information Seeking and Intention, run by University of Colorado, Denver.
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 2 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intention to Seek Information - 1 (time frame: 1 day (one time while participants viewed the brief intervention.)). 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?
On the ClinicalTrials.gov record for NCT05206669, which also lists 1 linked publication.
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 25 Jan 2022.