Human Papillomavirus Infection Clinical Trial
Official title:
Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers in Adolescents
Verified date | February 2014 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Unknown status |
Enrollment | 600 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 15 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Teen Health Centers | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Merck Sharp & Dohme Corp. |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Completion of three dose series of Gardasil | We will identify all enrolled parents to determine whether their adolescent received all three required Gardasil immunization across a three year period. | Three years | |
Secondary | Message type | Determine whether the type of message delivered to parent, i.e., one-sided or two-sided, increases the number of first dose immunizations. | Two years | |
Secondary | Gender | Determine if there are gender differences between male and female children relative to first dose administration | One year |
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