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


N/A
11 Years
15 Years
Open (Enrolling)
Both
Human Papillomavirus Infection

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Trial Information

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


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 Gardasilâ„¢, 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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Gardasil immunization

Outcome Description:

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.

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Vaughn I Rickert, PsyD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

0911-50

NCT ID:

NCT01087164

Start Date:

September 2010

Completion Date:

November 2013

Related Keywords:

  • Human Papillomavirus Infection
  • Vaccine acceptance
  • human papillomavirus
  • brief messages
  • social compliance
  • Message sidedness
  • Social compliance
  • Warts
  • Papillomavirus Infections

Name

Location

Teen Health Centers Galveston, Texas  77550