Neoplasms

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Infections

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Vaccines

Jason Wright, MD

Worldwide cervical cancer remains a major cause mortality among women. It is estimated that each year over 490,000 women are diagnosed with cervical cancer and more than 270,000 die from the disease. While the implementation of widespread screening programs has reduced the burden of cervical cancer, a large percentage of the population still remains unscreened or is underscreened. It is now recognized that human papillomavirus (HPV) is a necessary precursor for the development of cervical cancer. The first vaccine to prevent HPV was recently approved by the Food and Drug Administration and is now available at doctors offices. Despite the availability of a safe and effective means for the prevention of cervical cancer, widespread implementation of vaccination has been extremely difficult. Several potential issues have limited the development of widespread HPV vaccination programs, including cultural and religious beliefs, and limitations in the practicality of administering the vaccine. The overall goals of our work are to improve access to preventive strategies for cervical cancer. In this proposal we will examine the strategy of HPV vaccination for women who have just given birth. We believe that HPV vaccination of these women will be associated with a high level of patient satisfaction and acceptance. If successful, this strategy could play a major role in advancing the acceptance and implementation of HPV vaccination in the United States.

Primary Objective

1. To estimate compliance with the HPV vaccine series when initiated in postpartum women.

Secondary Objectives

1. To determine patient acceptance and satisfaction with HPV vaccination administered in the postpartum period.
2. To determine predictors of compliance with the HPV vaccination series.

Acceptance of Human Papillomavirus Vaccination in Postpartum Women

Merck Sharp & Dohme LLC

Columbia University

Assistant Professor of Gynecologic Oncology

Brief (47 second) animated informational video about vaccines recommended for all young adolescents.

Intervention includes the General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).

Intervention includes the General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".

General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.

Top Concern Tailored Intervention

General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.

All Concerns Tailored Intervention

Gregory D Zimet, PhD

The purpose of this study is to investigate mother's attitudes about vaccinating their 11-14 year old children against the human papillomavirus (HPV). Among mothers who do not plan to vaccinate their child, the investigators will assess the influence of brief videos tailored to mothers' questions and concerns. Mothers will be randomized to one of three arms: 1. General video message about vaccination; 2. General message plus a brief video addressing the mother's primary concern; or 3. General message plus videos address all of mother-indicated concerns. The outcome of interest is intention to vaccinate. Our hypothesis is that the tailored videos will lead to increased intention to vaccinate.

Attitudes will be assessed through a Web-based survey administered by Survey Sampling International (SSI). The projected sample size is approximately 3,500, comprising mothers or female guardians of at least one child aged 11-14 who live in the United States. The survey will take no more than 20 minutes to complete. Mothers who indicate that they do not plan to vaccinate their children in the next year will be randomized to view brief videos tailored to their questions or concerns about HPV vaccination. The outcome of interest is intention to vaccinate. Mothers who have vaccinated their child or intend to vaccinate their child will be asked a separate set of questions relevant to this information.

Mothers who indicate that they do not intend to vaccinate their child against HPV will be asked about their questions or concerns regarding HPV vaccination (from a pre-populated list of common concerns). Mothers will be randomized to one of three arms: 1. A general information video; 2. The general video plus a video addressing their top concern; or 3. The general video plus one or more videos addressing all of their concerns. Each video is less than 50 seconds in length.

Intervention videos delivered via anonymous online surveys through Survey Sampling International. Randomization to condition is built into the online survey. Participants will not know to which condition they will be randomized. Investigators are blinded by virtue of the built in randomization and anonymity of the survey.

Mothers or female guardians of children 11-14 years of age

An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination

"Keeping All Teens Healthy Study": An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination

Each parent will be asked to respond to this question. The response will be scaled from 1-10 in terms of parental intent regarding vaccination, with higher scores meaning greater parental intent to vaccinate children.

Indiana University

This study involved participants completing a 20 minute online survey. Therefore, there was zero risk for either mortality or serious adverse events.

General Vaccine Information

Intervention includes the General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above". For those indicating #6, they will receive the same video as those indicating #1 (need more information).

Top Concern Tailored Intervention: General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.

Intervention includes the General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. "I need more information about the vaccine"; 2. "My child is too young"; 3. "I am concerned about the long-term health effects or safety of the vaccine"; 4. "My child's health care provider did not recommend it or said my child could wait"; 5. "The vaccine is not required for school"; 6. "Other / none of the above".

All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.

Total

21-25 years old

25-30 years old

31-35 years old

36-40 years old

41-45 years old

46-50 years old

51-55 years old

56-60 years old

61-65 years old

66-70 years old

70-75 years old

Age, Customized

Female

Sex: Female, Male

Non-Hispanic White

Non-Hispanic Black

Non-Hispanic Other

Hispanic

Race/Ethnicity, Customized

Females

Males

Child's Sex: Female, Male

Child's Age, Continuous

A limitation of this trial is that the outcome is intention to vaccinate, rather than actual vaccination.

Dr. Gregory Zimet

Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acceptance of Human Papillomavirus Vaccination in Postpartum Women	NCT00730704	Human Papilloma... HPV Post Partum		18 Years - 26 Years	Columbia University
Acceptance of Human Papillomavirus Vaccination in Postpartum Women	NCT00730704	Human Papilloma... HPV Post Partum		18 Years - 26 Years	Columbia University
An Evaluation of Tailored Messages to Address Parental Questions About HPV Vaccination	NCT03628885	Human Papilloma... Attitude to Hea...	Top Concern Tai... All Concerns Ta...	18 Years -	Indiana University
Acceptance of Human Papillomavirus Vaccination in Postpartum Women	NCT00730704	Human Papilloma... HPV Post Partum		18 Years - 26 Years	Columbia University
Acceptance of Human Papillomavirus Vaccination in Postpartum Women	NCT00730704	Human Papilloma... HPV Post Partum		18 Years - 26 Years	Columbia University

Spots Global Cancer Trial Database for human papilloma virus vaccines