Human Papillomavirus VaccinesNCT02535845
Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination: Feasibility Trial
A study testing Project Voice and HPV Informational Video 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 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccines
- What is being tested?
- Project Voice and HPV Informational Video
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2017to 31 Jan 2019
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents: Undecided about the HPV vaccine
- Adolescent child: 11-17 years old and has not begun the HPV vaccine series.
Who cannot join
- Parents: Having impairing hearing or speech
- Adolescents: pregnant at the time of the clinic visit
- Dyad: participated in Phase 1 and 2 of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-8557
About this study
Official title: Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination
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 third phase of the study (the second stage is also registered in clinical trials).
Read the detailed description
Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine coverage among adolescents age 13-17 is poor (60% for girls, 41.7% 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. In Stage 3, reported here, investigators will conduct a two-arm pilot randomized control trial in the safety-net clinics to assess feasibility of testing the self-persuasion intervention condition against standard of care (control group). Parent-adolescent child dyads will be enrolled. Parents will be exposed to the intervention and the primary outcome (HPV vaccination) will be assessed on the adolescent child via the electronic health record. Investigators will also examine the impact of the intervention on parent-provider discussions about HPV vaccination.
- Conditions
- Human Papillomavirus Vaccines
- Being tested
- Project Voice, HPV Informational Video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project VoiceBehavioural
Project Voice tablet-based intervention plus informational video
HPV Informational VideoBehavioural
Informational video only
| Study group | Role | What they receive |
|---|---|---|
| Self-persuasion group | Experimental | HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Receives: Behavioral: Project Voice |
| Information only group | Active comparator | HPV information only in a tablet-based application (HPV Informational Video) Receives: Behavioral: HPV Informational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Vaccination Behavior Documented in Electronic Health Record, Initiation
Number of parents who decided to start the HPV vaccine three dose series and got their child vaccinated within 30 days of the study appointment as evidenced by documentation in the child's electronic medical record.
Measured: 30 days
Secondary outcomes (2)
HPV Vaccination Behavior Documented in Electronic Medical Record, Completion
Number of doses received and the dates of those doses within 15 months of the study appointment as evidenced by documentation in the child's electronic medical record.
Measured: 15 months
Active Parent Participation During Clinical Encounter
Investigators will explore the factors associated with parent degree of participation in the discussion with the healthcare provider during the clinical encounter using Street coding scheme of 3 types of active communication.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study start21 Dec 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Why it stopped: Halted early due to poor accrual and lack of time to receive intervention procedures adjacent to a clinic visit post randomization.
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 22 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
- Principal investigator, Jasmin A. Tiro, University of Texas Southwestern Medical Center
- 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
- NCT02535845
- Sponsor's protocol ID
- 1R01CA178414-04;STU 022013-016
- Other IDs
- 1R01CA178414
- Status last verified
- Jan 2024
- First submitted
- 26 Aug 2015
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 30 Jan 2024. 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
- NCT02535845
- Acronym / sponsor ID
- 1R01CA178414-04;STU 022013-016
- Conditions
- Human Papillomavirus Vaccines
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted early due to poor accrual and lack of time to receive intervention procedures adjacent to a clinic visit post randomization.
- Enrolment
- 22 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
- 21 Dec 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Posted 30 Jan 2024
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 third phase of the study (the second stage is also registered in clinical trials).
Detailed description
Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine coverage among adolescents age 13-17 is poor (60% for girls, 41.7% 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. In Stage 3, reported here, investigators will conduct a two-arm pilot randomized control trial in the safety-net clinics to assess feasibility of testing the self-persuasion intervention condition against standard of care (control group). Parent-adolescent child dyads will be enrolled. Parents will be exposed to the intervention and the primary outcome (HPV vaccination) will be assessed on the adolescent child via the electronic health record. Investigators will also examine the impact of the intervention on parent-provider discussions about HPV vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-persuasion group | Experimental | Behavioral: Project VoiceHPV information plus self-persuasion intervention in a tablet-based application (Project Voice) |
| Information only group | Active comparator | Behavioral: HPV Informational VideoHPV information only in a tablet-based application (HPV Informational Video) |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents: Undecided about the HPV vaccine
- Adolescent child: 11-17 years old and has not begun the HPV vaccine series.
Key exclusion criteria (3 listed)
- Parents: Having impairing hearing or speech
- Adolescents: pregnant at the time of the clinic visit
- Dyad: participated in Phase 1 and 2 of 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 |
|---|---|---|
| Project VoiceProject Voice tablet-based intervention plus informational video | Behavioural | Self-persuasion group |
| HPV Informational VideoInformational video only | Behavioural | Information only group |
Primary outcome
HPV Vaccination Behavior Documented in Electronic Health Record, Initiation
Time frame: 30 days
Number of parents who decided to start the HPV vaccine three dose series and got their child vaccinated within 30 days of the study appointment as evidenced by documentation in the child's electronic medical record.
2 secondary outcomes
HPV Vaccination Behavior Documented in Electronic Medical Record, Completion
Time frame: 15 months
Active Parent Participation During Clinical Encounter
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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 and HPV Informational Video 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 Jan 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 30 Jan 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?
HPV Vaccination Behavior Documented in Electronic Health Record, Initiation (time frame: 30 days). 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 NCT02535845, 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 30 Jan 2024.