Human Papillomavirus Vaccines
Conditions
Brief 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. 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.
Interventions
Project Voice tablet-based intervention plus informational video
Informational video only
Sponsors
Study design
Eligibility
Inclusion criteria
for the Parent-Adolescent Dyad: * Parents: Undecided about the HPV vaccine * Adolescent child: 11-17 years old and has not begun the HPV vaccine series.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV Vaccination Behavior Documented in Electronic Health Record, Initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV Vaccination Behavior Documented in Electronic Medical Record, Completion | 15 months | 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. |
| Active Parent Participation During Clinical Encounter | 1 day | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| Self-persuasion Group- Adolescent 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 | 7 |
| Information Only Group - Parent HPV information only in a tablet-based application (HPV Informational Video)
HPV Informational Video: Informational video only | 4 |
| Information Only Group - Adolescent Parent exposed to HPV information only in a tablet-based application (HPV Informational Video)
HPV Informational Video: Informational video only | 4 |
| Total | 22 |
Baseline characteristics
| Characteristic | Self-persuasion Group-Parent | Self-persuasion Group- Adolescent | Information Only Group - Parent | Information Only Group - Adolescent | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 7 Participants | 0 Participants | 4 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 0 Participants | 4 Participants | 0 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 1 Participants | 1 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 1 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 4 Participants | 2 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 5 Participants | 0 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 30 days
Population: Data were not collected due to early termination of the study
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.
Time frame: 1 day
Population: Data were not collected due to early termination of the study
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.
Time frame: 15 months
Population: Data were not collected due to early termination of the study