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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA178414 | U.S. NIH Grant/Contract | View source |
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Halted early due to poor accrual and lack of time to receive intervention procedures adjacent to a clinic visit post randomization.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Southern Methodist University | OTHER |
| Parkland Health and Hospital System | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-persuasion group | Experimental | HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) |
|
| Information only group | Active Comparator | HPV information only in a tablet-based application (HPV Informational Video) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project Voice | Behavioral | Project Voice tablet-based intervention plus informational video |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 months |
| Active Parent Participation During Clinical Encounter |
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Inclusion Criteria for the Parent-Adolescent Dyad:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jasmin A Tiro, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Austin S Baldwin, PhD | Southern Methodist University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390-8557 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26825137 | Derived | 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. |
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Parent-adolescent dyads were randomized to intervention arms. Parents were exposed to the intervention arm. Primary outcome measure (HPV vaccination) was assessed on the adolescent child via the electronic health record. The number started/completed represents the number of parent-adolescent dyads.
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-persuasion Group - Parent | HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video |
| FG001 | Self-persuasion Group - Adolescent | Adolescent's parent was exposed to HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video |
| FG002 | Information Only Group - Parent | HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only |
| FG003 | Information Group Only - Adolescent | HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-persuasion Group-Parent | HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video |
| BG001 | Self-persuasion Group- Adolescent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data were not collected due to early termination of the study | Posted | 30 days |
|
Day of visit (1 day)
Adverse event definitions are the same as clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-persuasion Group - Parents | HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jasmin Tiro | The University of Chicago | 773-834-4384 | jtiro@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2018 | Oct 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2018 | Oct 5, 2023 | ICF_001.pdf |
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| HPV Informational Video | Behavioral | Informational video only |
|
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. |
| 1 day |
Parent exposed to HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video |
| BG002 | Information Only Group - Parent | HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only |
| BG003 | Information Only Group - Adolescent | Parent exposed to HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Information Only Group - Parent | HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only |
| OG003 | Information Only Group - Adolescent | Parent exposed to HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only |
|
| Secondary | 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. | Data were not collected due to early termination of the study | Posted | 15 months |
|
|
| Secondary | 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. | Data were not collected due to early termination of the study | Posted | 1 day |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Self-persuasion Group - Adolescents | HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Information Only Group-Parents | HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | Information Only Group - Adolescents | HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only | 0 | 4 | 0 | 4 | 0 | 4 |
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