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

The University of Texas System (UT)

Status: Terminated

Conditions: Human Papillomavirus Vaccines

Treatments: Behavioral: Project Voice; Behavioral: HPV Informational Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02535845

1R01CA178414-04 STU 022013-016;

1R01CA178414 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 11+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Self-persuasion group

Experimental group

Description:

HPV information plus self-persuasion intervention in a tablet-based application (Project Voice)

Treatment:

Behavioral: Project Voice

Information only group

Active Comparator group

Description:

HPV information only in a tablet-based application (HPV Informational Video)

Treatment:

Behavioral: HPV Informational Video