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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Vaughn Rickert, Indiana University
ClinicalTrials.gov Identifier:
NCT01087164
First received: February 2, 2009
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Human Papillomavirus Infection
Behavioral: Compliance
Behavioral: Message sidedness

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers in Adolescents

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Gardasil immunization [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Completion of three dose series of Gardasil [ Time Frame: Three years ] [ Designated as safety issue: No ]
    We will identify all enrolled parents to determine whether their adolescent received all three required Gardasil immunization across a three year period.

  • Message type [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Determine whether the type of message delivered to parent, i.e., one-sided or two-sided, increases the number of first dose immunizations.

  • Gender [ Time Frame: One year ] [ Designated as safety issue: No ]
    Determine if there are gender differences between male and female children relative to first dose administration


Estimated Enrollment: 600
Study Start Date: September 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compliance
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
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.
Experimental: Message sidedness
Parents will be given either a one-sided verbal message or a two-sided verbal message about the HPV vaccine.
Behavioral: Message sidedness
Parent will receive either a one-sided or two-sided message about the HPV vaccine

Detailed Description:

The proposed study will employ a randomized, full factorial experimental design to examine the effects of brief message interventions on parents' acceptance of the first dose of HPV vaccine for their adolescents aged 11-14 years, as well as follow through with subsequent doses. Specifically, the study will employ a 2 x 2 experimental design, in which participants will be assigned randomly to one of two different message sidedness conditions (1 sided vs. 2 sided) and two social compliance conditions (high compliance request [HCR] vs. noHCR). The interventions will be administered by a bilingual research assistant who will read, verbatim, scripts provided to them. Computer assisted telephone interview (CATI) will be used to gather demographic and background information as well as parental health beliefs regarding preexisting worries about HPV vaccine leading to safety concerns (moderator variable) prior to administration of the interventions. After the interventions, additional health beliefs will be assessed (mediators).

  1. A greater proportion of girls as compared to boys will receive a first dose of vaccine.
  2. Among both girls and boys who receive a first dose of Gardasil™, no differences in completion rates will be detected.
  3. The social compliance intervention to be more effective with parents of girls as compared to parents of boys. This prediction of a differential effect is based on the fact that cervical cancer will be seen as a more serious and less stigmatizing condition than genital warts.

In summary, the implementation of this protocol will allow us to systematically examine the use of two different interventions on parents of both boys and girls. Thus, parents (n=800) of 11-14 year old girls and boys will be randomized to the two sets of interventions, resulting in a 2 X 2 design: message sidedness (1-sided; 2-sided) and HCR (yes; no).

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Having received one or more doses of the HPV vaccine Gardasil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087164

Locations
United States, Texas
Teen Health Centers
Galveston, Texas, United States, 77550
Sponsors and Collaborators
Indiana University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Vaughn I Rickert, PsyD Indiana University School of Medicine
  More Information

Publications:
Responsible Party: Vaughn Rickert, Professor and Director, Section of Adolescent Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01087164     History of Changes
Other Study ID Numbers: 0911-50
Study First Received: February 2, 2009
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Vaccine acceptance
human papillomavirus
brief messages
social compliance
Message sidedness
Social compliance

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on August 26, 2014