Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers
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|ClinicalTrials.gov Identifier: NCT01087164|
Recruitment Status : Unknown
Verified February 2014 by Vaughn Rickert, Indiana University.
Recruitment status was: Active, not recruiting
First Posted : March 16, 2010
Last Update Posted : February 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus Infection||Behavioral: Compliance Behavioral: Message sidedness||Not Applicable|
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).
- A greater proportion of girls as compared to boys will receive a first dose of vaccine.
- Among both girls and boys who receive a first dose of Gardasil™, no differences in completion rates will be detected.
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers in Adolescents|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
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.
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
- Gardasil immunization [ Time Frame: One year ]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.
- Completion of three dose series of Gardasil [ Time Frame: Three years ]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 ]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 ]Determine if there are gender differences between male and female children relative to first dose administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087164
|United States, Texas|
|Teen Health Centers|
|Galveston, Texas, United States, 77550|
|Principal Investigator:||Vaughn I Rickert, PsyD||Indiana University School of Medicine|