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Compliance for Human Papillomavirus

N/A
Waitlist Available
Led By Vaughn I Rickert, PsyD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Human Papillomavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gardasil immunization
Secondary study objectives
Completion of three dose series of Gardasil
Gender
Message type

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Message sidednessExperimental Treatment1 Intervention
Parents will be given either a one-sided verbal message or a two-sided verbal message about the HPV vaccine.
Group II: ComplianceExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Compliance
2006
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,036 Previous Clinical Trials
1,218,398 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,001 Previous Clinical Trials
5,184,311 Total Patients Enrolled
Vaughn I Rickert, PsyDPrincipal InvestigatorIndiana University School of Medicine
~40 spots leftby Nov 2025