Human Papillomavirus Infection Clinical Trial
Official title:
Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers in Adolescents
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.
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).
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