Clinical trial NCT02535845: Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination: Feasibility Trial
Official title: Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Human Papillomavirus Vaccines
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Southern Methodist University
name: Parkland Health and Hospital System
First posted: 2015-08-31
Enrollment: 22
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HPV Vaccination Behavior Documented in Electronic Health Record, Initiation
timeFrame: 30 days
Secondary outcomes:
measure: HPV Vaccination Behavior Documented in Electronic Medical Record, Completion
timeFrame: 15 months
measure: Active Parent Participation During Clinical Encounter
timeFrame: 1 day
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Jasmin A Tiro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Methodist University
name: Austin S Baldwin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.