Human Papillomavirus InfectionNCT01087164
Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers
A study testing Compliance and Message sidedness in people with Human Papillomavirus Infection, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Compliance and Message sidedness
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Having received one or more doses of the HPV vaccine Gardasil
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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).
- 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).
- Conditions
- Human Papillomavirus Infection
- Being tested
- Compliance, Message sidedness
- Keywords
- Vaccine acceptance, human papillomavirus, brief messages, social compliance, Message sidedness
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComplianceBehavioural
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.
Message sidednessBehavioural
Parent will receive either a one-sided or two-sided message about the HPV vaccine
| Study group | Role | What they receive |
|---|---|---|
| Compliance | Experimental | 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. Receives: Behavioral: Compliance |
| Message sidedness | Experimental | Parents will be given either a one-sided verbal message or a two-sided verbal message about the HPV vaccine. Receives: Behavioral: Message sidedness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (3)
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.
Measured: Three years
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.
Measured: Two years
Gender
Determine if there are gender differences between male and female children relative to first dose administration
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Vaughn Rickert, Indiana University
- Investigators
- Vaughn I Rickert, PsyD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087164
- Sponsor's protocol ID
- 0911-50
- Status last verified
- Feb 2014
- First submitted
- 2 Feb 2009
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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. Epub 2014 Jan 31.
PubMed 24492015
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers in Adolescents
- ClinicalTrials.gov ID
- NCT01087164
- Acronym / sponsor ID
- 0911-50
- Conditions
- Human Papillomavirus Infection
- Keywords
- Vaccine acceptance, human papillomavirus, brief messages, social compliance, Message sidedness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compliance | Experimental | Behavioral: ComplianceParents 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. |
| Message sidedness | Experimental | Behavioral: Message sidednessParents will be given either a one-sided verbal message or a two-sided verbal message about the HPV vaccine. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Having received one or more doses of the HPV vaccine Gardasil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComplianceParent 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. | Behavioural | Compliance |
| Message sidednessParent will receive either a one-sided or two-sided message about the HPV vaccine | Behavioural | Message sidedness |
Primary outcome
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.
3 secondary outcomes
Completion of three dose series of Gardasil
Time frame: Three years
Message type
Time frame: Two years
Gender
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Results publication: PubMed 24492015Rickert 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. Epub 2014 Jan 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaughn I Rickert, PsyD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compliance and Message sidedness in people with Human Papillomavirus Infection, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gardasil immunization (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01087164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014; AzTrials last refreshed its copy on 1 Nov 2026.