Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01087164
Study type Interventional
Source Indiana University
Contact
Status Unknown status
Phase N/A
Start date September 2010
Completion date June 2014

See also
  Status Clinical Trial Phase
Completed NCT05458869 - Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma
Completed NCT01932697 - Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer Phase 2
Completed NCT03265743 - HPV Vaccination in Women With Cystic Fibrosis N/A
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A
Completed NCT06199128 - Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients
Active, not recruiting NCT01824537 - Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study Phase 4
Terminated NCT01082861 - Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination Phase 4
Completed NCT01265212 - Prevalence of Human Papillomavirus in Men Living in the Northern Plains N/A
Completed NCT00572832 - Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting N/A
Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Recruiting NCT05210348 - Clinical Evaluation of Detection of High Risk HPV in Urine
Completed NCT05680454 - A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine Phase 1
Completed NCT04133610 - HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs N/A
Completed NCT00988884 - A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005) Phase 3
Not yet recruiting NCT05981807 - HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population
Recruiting NCT03302858 - A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand Phase 2
Completed NCT01694875 - Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System N/A
Completed NCT01205412 - An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain N/A
Completed NCT01158209 - An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt N/A