Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers

NCT01087164 | Unknown

• 1 other identifier: 0911-50
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Using health behavior theories and theories related to the effects of persuasive messages (i.e., inoculation theory), we plan to: 1. Systematically test the effects of brief persuasive message interventions on receipt of the first dose of HPV vaccine; and 2. evaluate the effects of the interventions on followup with subsequent doses of vaccine (using reminder notices with persuasive message content). One set of interventions will involve a comparison of a 1 sided message, which only emphasizes the positive aspects of a recommended behavior, with a 2 sided message, which presents negative aspects of the behavior followed by positive counterarguments. A second set of interventions will involve a test of a social compliance (foot-in-the-door technique, in which half of the parent participants will be asked to respond to a high compliance request (i.e., a request likely to generate high compliance, such as, "Do you want to protect your daughter from cancer? or for male children, "Do you want to protect your son from genital warts?"before subsequently being asked about actually having their adolescents vaccinated. The other half of the parents will not receive a high compliance request. Parents of 11-14 year old adolescents will be randomized to the two sets of interventions, resulting in a 2 X 2 design: message sidedness (1 sided; 2 sided) and social compliance request (yes; no). The specific aims of this proposal are to evaluate the 1) efficacy of 2 sided vs. 1 sided messages on rates of HPV vaccination; 2) the efficacy of a social compliance intervention on rates of HPV vaccination; and 3) potential moderators and mediators of message effect on vaccine acceptance.

Conditions

Human Papillomavirus Infection

Keywords

Vaccine acceptance; human papillomavirus; brief messages; social compliance; Message sidedness

Outcome Measures

Primary Outcomes (1)

• Gardasil immunization

  Parent signs vaccine information sheet and returns to school-based health center. Adolescent is vaccinated with first dose of Gardasil by licensed health care professional.

  One year

Secondary Outcomes (3)

• Completion of three dose series of Gardasil

  Three years

• Message type

  Two years

• Gender

  One year

Study Arms (2)

Compliance

EXPERIMENTAL

Parents will be randomized to receive high or no compliance condition where those in the experimental group will be asked about whether or not they will protect their daughter from cervical cancer or for males, their son from genital warts.

Behavioral: Compliance

Message sidedness

EXPERIMENTAL

Parents will be given either a one-sided verbal message or a two-sided verbal message about the HPV vaccine.

Behavioral: Message sidedness

Interventions

Compliance BEHAVIORAL

Parent will either receive a high or no compliance condition where each is asked to endorse the importance of prevention cervical cancer or genital warts depending on their teen's gender.

Compliance

Message sidedness BEHAVIORAL

Parent will receive either a one-sided or two-sided message about the HPV vaccine

Message sidedness

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The parents of adolescent males and females (aged 11-14 years) who have provided written consent for their adolescent to receive health care services through the Teen Health Center, Inc, a nonprofit organization that works in collaboration with the Department of Pediatrics at the University of Texas Medical Branch, Galveston, Texas and whose adolescents have not received their first dose of HPV vaccine, will be eligible to participate.

You may not qualify if:

• Having received one or more doses of the HPV vaccine Gardasil

Sponsors & Collaborators

• Indiana University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Teen Health Centers

Galveston, Texas, 77550, United States

Location

Related Publications (1)

• Rickert VI, Auslander BA, Cox DS, Rosenthal SL, Rickert JA, Rupp R, Zimet GD. School-based vaccination of young US males: impact of health beliefs on intent and first dose acceptance. Vaccine. 2014 Apr 7;32(17):1982-7. doi: 10.1016/j.vaccine.2014.01.049. Epub 2014 Jan 31.

  PMID: 24492015 RESULT

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Compliance

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Elasticity; Mechanical Phenomena; Physical Phenomena

Study Officials

• Vaughn I Rickert, PsyD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Section of Adolescent Medicine

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: March 16, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

US (1)