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Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination: Feasibility Trial

Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02535845
Enrollment
22
Registered
2015-08-31
Start date
2017-12-21
Completion date
2019-01-31
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus Vaccines

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

BEHAVIORALProject Voice

Project Voice tablet-based intervention plus informational video

BEHAVIORALHPV Informational Video

Informational video only

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Southern Methodist University
CollaboratorOTHER
Parkland Health and Hospital System
CollaboratorOTHER
University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
HPV Vaccination Behavior Documented in Electronic Health Record, Initiation30 daysNumber 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

MeasureTime frameDescription
HPV Vaccination Behavior Documented in Electronic Medical Record, Completion15 monthsNumber 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 Encounter1 dayInvestigators 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

ArmCount
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
Total22

Baseline characteristics

CharacteristicSelf-persuasion Group-ParentSelf-persuasion Group- AdolescentInformation Only Group - ParentInformation Only Group - AdolescentTotal
Age, Categorical
<=18 years
0 Participants7 Participants0 Participants4 Participants11 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
7 Participants0 Participants4 Participants0 Participants11 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants4 Participants1 Participants1 Participants10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants3 Participants3 Participants3 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants3 Participants3 Participants3 Participants12 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
4 Participants4 Participants1 Participants1 Participants10 Participants
Sex: Female, Male
Female
7 Participants2 Participants4 Participants2 Participants15 Participants
Sex: Female, Male
Male
0 Participants5 Participants0 Participants2 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 70 / 40 / 4
other
Total, other adverse events
0 / 70 / 70 / 40 / 4
serious
Total, serious adverse events
0 / 70 / 70 / 40 / 4

Outcome results

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.

Time frame: 30 days

Population: Data were not collected due to early termination of the study

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.

Time frame: 1 day

Population: Data were not collected due to early termination of the study

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.

Time frame: 15 months

Population: Data were not collected due to early termination of the study

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026