Human Papillomavirus VaccinesNCT02537756
Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination
A study testing Project Voice in people with Human Papillomavirus Vaccines, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true among traditionally underserved adolescents. Few parent-targeted interventions have focused on the parental decision-making process. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccines
- What is being tested?
- Project Voice
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 737 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2016to 26 Oct 2019
- 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
- Undecided parents (18 years and older) whose children are 11-17 year old patients who have not begun the HPV vaccine series.
Who cannot join
- Parents whose child is a pregnant adolescent
- Lack telephone access
- Having impairing hearing or speech
- Participants will be excluded from participation in future stages
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-8557
About this study
HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true among traditionally underserved adolescents. Few parent-targeted interventions have focused on the parental decision-making process. Self-persuasion, generating one's own arguments for engaging in a behavior, may be an effective means to influence parents' motivation to vaccinate their children. In a three-phase study, investigators are using quantitative and qualitative research methods to develop and refine a tablet-based self-persuasion intervention for parents who are undecided about the HPV vaccine. This clinical trial submission focuses on the second phase of the study. The results of the second phase will inform the third phase of the trial (also registered in clinical trials).
Read the detailed description
Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine 3 dose coverage among adolescents is poor (38% for girls, 14% for boys). HPV-related cancers are a significant burden on the US healthcare system and could be prevented through adolescent vaccination. Rates of vaccination are suboptimal among underserved populations (uninsured, low-income, racial and ethnic minorities) often seen in safety-net clinics. Few interventions have been designed that target decision-making among parents of unvaccinated adolescents. Self-persuasion, generating of one's own arguments for a health behavior, may be an effective means of influencing HPV vaccination behaviors among undecided or ambivalent parents. Through three stages, investigators will identify and develop a self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. The current trial, Stage 2, is a four-arm randomized controlled trial (RCT), using a 2x2 factorial design, in which investigators will assign participants to one of four self-persuasion intervention conditions that vary by cognitive processing level (verbalize vs. listen to arguments) and choice of argument topics (parents choose vs. are assigned topics) to identify which intervention condition is optimal. Conducted in a laboratory setting, investigators will identify and select the optimal intervention condition through quantitative analysis of the effects on parents' vaccination intentions and qualitatively by exploring parental experiences with the self-persuasion tasks.
- Conditions
- Human Papillomavirus Vaccines
- Being tested
- Project Voice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project VoiceBehavioural
A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition
| Study group | Role | What they receive |
|---|---|---|
| 1- Verbalize, Choice | Experimental | Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics they choose Receives: Behavioral: Project Voice |
| 2- Listen, Choice | Experimental | Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics they choose Receives: Behavioral: Project Voice |
| 3- Verbalize, Assigned | Experimental | Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics assigned to them Receives: Behavioral: Project Voice |
| 4- Listen, Assigned | Experimental | Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics assigned to them Receives: Behavioral: Project Voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey Items Measuring Parental Intentions to vaccinate
Change in intentions of the parent to vaccinate from baseline survey to exit survey using measures adapted from Gerend \& Shepherd (2012). Intentions Likert Scale responses range from 1-very likely to 5-very unlikely.
Measured: During the intervention visit (1 hr)
Secondary outcomes (2)
HPV vaccination behavior documented in the electronic medical record, initiation
Number of parents who initiated the series by vaccinating their child within 12 months of the study appointment as evidenced by documentation in the child's electronic medical record.
Measured: 12 months
Change in Decision Stage
Change in decision stage response of parents from baseline survey to post-educational video to post-intervention tasks.
Measured: During the intervention visit (1 hr)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start5 Apr 2016
- Primary completion26 Jul 2018
- Study completion26 Oct 2019
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 Human Papillomavirus VaccinesStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Southern Methodist University, Parkland Health and Hospital System
- Responsible party
- Sponsor
- Investigators
- Jasmin A Tiro, PhD, Principal investigator, University of Texas Southwestern Medical CenterAustin S Baldwin, PhD, Principal investigator, Southern Methodist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537756
- Sponsor's protocol ID
- STU 022013-016
- Other IDs
- 1R01CA178414-01
- Status last verified
- May 2020
- First submitted
- 26 Aug 2015
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal and sign a data use agreement. Proposals should be submitted to Dr. Jasmin Tiro (jasmin.tiro@utsouthwestern.edu).
Publications
Tiro JA, Lee SC, Marks EG, Persaud D, Skinner CS, Street RL, Wiebe DJ, Farrell D, Bishop WP, Fuller S, Baldwin AS. Developing a Tablet-Based Self-Persuasion Intervention Promoting Adolescent HPV Vaccination: Protocol for a Three-Stage Mixed-Methods Study. JMIR Res Protoc. 2016 Jan 29;5(1):e19. doi: 10.2196/resprot.5092.
PubMed 26825137
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination
- ClinicalTrials.gov ID
- NCT02537756
- Acronym / sponsor ID
- STU 022013-016
- Conditions
- Human Papillomavirus Vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 737 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Southern Methodist University, Parkland Health and Hospital System
- Study start
- 5 Apr 2016 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Oct 2019 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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.
HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true among traditionally underserved adolescents. Few parent-targeted interventions have focused on the parental decision-making process. Self-persuasion, generating one's own arguments for engaging in a behavior, may be an effective means to influence parents' motivation to vaccinate their children. In a three-phase study, investigators are using quantitative and qualitative research methods to develop and refine a tablet-based self-persuasion intervention for parents who are undecided about the HPV vaccine. This clinical trial submission focuses on the second phase of the study. The results of the second phase will inform the third phase of the trial (also registered in clinical trials).
Detailed description
Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine 3 dose coverage among adolescents is poor (38% for girls, 14% for boys). HPV-related cancers are a significant burden on the US healthcare system and could be prevented through adolescent vaccination. Rates of vaccination are suboptimal among underserved populations (uninsured, low-income, racial and ethnic minorities) often seen in safety-net clinics. Few interventions have been designed that target decision-making among parents of unvaccinated adolescents. Self-persuasion, generating of one's own arguments for a health behavior, may be an effective means of influencing HPV vaccination behaviors among undecided or ambivalent parents. Through three stages, investigators will identify and develop a self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. The current trial, Stage 2, is a four-arm randomized controlled trial (RCT), using a 2x2 factorial design, in which investigators will assign participants to one of four self-persuasion intervention conditions that vary by cognitive processing level (verbalize vs. listen to arguments) and choice of argument topics (parents choose vs. are assigned topics) to identify which intervention condition is optimal. Conducted in a laboratory setting, investigators will identify and select the optimal intervention condition through quantitative analysis of the effects on parents' vaccination intentions and qualitatively by exploring parental experiences with the self-persuasion tasks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1- Verbalize, Choice | Experimental | Behavioral: Project VoiceParents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics they choose |
| 2- Listen, Choice | Experimental | Behavioral: Project VoiceParents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics they choose |
| 3- Verbalize, Assigned | Experimental | Behavioral: Project VoiceParents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics assigned to them |
| 4- Listen, Assigned | Experimental | Behavioral: Project VoiceParents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics assigned to them |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undecided parents (18 years and older) whose children are 11-17 year old patients who have not begun the HPV vaccine series.
Key exclusion criteria (4 listed)
- Parents whose child is a pregnant adolescent
- Lack telephone access
- Having impairing hearing or speech
- Participants will be excluded from participation in future stages
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 |
|---|---|---|
| Project VoiceA tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition | Behavioural | 1- Verbalize, Choice, 2- Listen, Choice, 3- Verbalize, Assigned, 4- Listen, Assigned |
Primary outcome
Survey Items Measuring Parental Intentions to vaccinate
Time frame: During the intervention visit (1 hr)
Change in intentions of the parent to vaccinate from baseline survey to exit survey using measures adapted from Gerend \& Shepherd (2012). Intentions Likert Scale responses range from 1-very likely to 5-very unlikely.
2 secondary outcomes
HPV vaccination behavior documented in the electronic medical record, initiation
Time frame: 12 months
Change in Decision Stage
Time frame: During the intervention visit (1 hr)
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 18 May 2020.
- Derived from this study: PubMed 26825137Tiro JA, Lee SC, Marks EG, Persaud D, Skinner CS, Street RL, Wiebe DJ, Farrell D, Bishop WP, Fuller S, Baldwin AS. Developing a Tablet-Based Self-Persuasion Intervention Promoting Adolescent HPV Vaccination: Protocol for a Three-Stage Mixed-Methods Study. JMIR Res Protoc. 2016 Jan 29;5(1):e19. doi: 10.2196/resprot.5092.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal and sign a data use agreement. Proposals should be submitted to Dr. Jasmin Tiro (jasmin.tiro@utsouthwestern.edu).
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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.
Jasmin A Tiro, PhD principal investigator
University of Texas Southwestern Medical Center
Austin S Baldwin, PhD principal investigator
Southern Methodist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Voice in people with Human Papillomavirus Vaccines, run by University of Texas Southwestern Medical Center 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 1 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 18 May 2020. 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?
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?
Survey Items Measuring Parental Intentions to vaccinate (time frame: During the intervention visit (1 hr)). 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 NCT02537756, 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 18 May 2020.