Clinical trial NCT02537756: Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination
Official title: Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2015-09-02
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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 second phase of the study. The results of the second phase will inform the third phase of the trial (also registered in clinical trials).

Detailed description: Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine 3 dose coverage among adolescents is poor (38% for girls, 14% 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. The current trial, Stage 2, is a four-arm randomized controlled trial (RCT), using a 2x2 factorial design, in which investigators will assign participants to one of four self-persuasion intervention conditions that vary by cognitive processing level (verbalize vs. listen to arguments) and choice of argument topics (parents choose vs. are assigned topics) to identify which intervention condition is optimal. Conducted in a laboratory setting, investigators will identify and select the optimal intervention condition through quantitative analysis of the effects on parents' vaccination intentions and qualitatively by exploring parental experiences with the self-persuasion tasks.

Eligibility criteria: Inclusion Criteria:

* Undecided parents (18 years and older) whose children are 11-17 year old patients who have not begun the HPV vaccine series.

Exclusion Criteria:

* Parents whose child is a pregnant adolescent
* Lack telephone access
* Having impairing hearing or speech
* Participants will be excluded from participation in future stages

Primary outcomes:
measure: Survey Items Measuring Parental Intentions to vaccinate
timeFrame: During the intervention visit (1 hr)
Secondary outcomes:
measure: HPV vaccination behavior documented in the electronic medical record, initiation
timeFrame: 12 months
measure: Change in Decision Stage
timeFrame: During the intervention visit (1 hr)
Other outcomes:
measure: HPV vaccination behavior documented in the electronic medical record, completion
timeFrame: 15 months
measure: Vaccination Concerns, qualitative
timeFrame: During the intervention visit (1 hr)
measure: Manipulation checks
timeFrame: During the intervention visit (1 hr)
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.