Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

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.

Parents will be given either a one-sided verbal message or a two-sided verbal message about the HPV vaccine.

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.

Compliance

Parent will receive either a one-sided or two-sided message about the HPV vaccine

Message sidedness

Vaughn I Rickert, PsyD

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.

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).

Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers

Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers in Adolescents

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.

We will identify all enrolled parents to determine whether their adolescent received all three required Gardasil immunization across a three year period.

Determine whether the type of message delivered to parent, i.e., one-sided or two-sided, increases the number of first dose immunizations.

Determine if there are gender differences between male and female children relative to first dose administration

Merck Sharp & Dohme LLC

Indiana University

Professor and Director, Section of Adolescent Medicine

Neoplasms

Papilloma

Vaccine-Preventable Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The intervention condition will present narrative-focused messages about HPV and the HPV vaccine that includes important parent focused exemplar language and cultural norms on Twitter told through stories and characters (i.e., pseudo-parents).

The non-narrative condition will present scientific-focused messages about HPV and the HPV vaccine that includes important information relayed with numbers and facts.

This study will evaluate the efficacy of social media messages through Twitter, using a randomized controlled trial to determine what types of messages resonate with parents. The investigators will examine narrative messages (i.e., stories). The central hypothesis is that parents who read narrative-focused messages will be more likely to report narrative engagement, intention to vaccinate their child, and self-reported vaccination compared to parents who read non-narrative messages.

HPV Twitter Education Program - Narrative

This study will evaluate the efficacy of social media messages through Twitter, using a randomized controlled trial to determine what types of messages resonate with parents. The investigators will examine non-narrative messages (i.e., scientific information - numbers and facts). The central hypothesis is that parents who read narrative-focused messages will be more likely to report narrative engagement, intention to vaccinate their child, and self-reported vaccination compared to parents who read non-narrative messages.

HPV Twitter Education Program - Non-Narrative

Philip M Massey, PhD, MPH

Parents use social media as an important parenting tool and source for health information. Using social media data to examine public opinion has had an early impact in public health and in cancer control and prevention efforts, including about the human papillomavirus (HPV) vaccine. A next step in this area of research is to develop and share messages on social media with parents to help inform and educate them about the HPV vaccine - ultimately assisting them with their decision to vaccinate their child. This study will evaluate the efficacy of social media messages through Twitter, using a randomized controlled trial to determine what types of messages resonate with parents. The investigators will examine differences between two types of messages - narrative messages (i.e., stories) and non-narrative messages (i.e., numbers and facts).

Approximately 80 million people in the United States - or about one in four - are infected with human papillomavirus (HPV). HPV can cause cancer and there are vaccines that protect against cancer-related strains. Evidence supporting vaccine efficacy and safety is robust, and vaccine availability is widespread; however coverage rates continue to fall short of the national goal of 80% (48.6% in 2017). Understanding the barriers to vaccine acceptance, particularly related to parent resistance and their informational needs, is key to strengthening vaccine uptake among adolescents. Communicating evidence to parents and engaging them through narrative strategies may address some of the barriers during the decision-making process. Parents use social media as an important parenting tool and useful source for health information. In 2015, 75% of all parents used social media, and of these 1 in 4 used Twitter - equating to millions of parent users. The investigators know that using social media data for surveillance has had early impact in public health. However, what is not known is the effectiveness of using large-scale social media data to inform a targeted social media intervention to support HPV vaccine uptake. This study will advance the growing field by evaluating the efficacy of an innovative narrative-focused intervention designed to communicate evidence and information about the HPV vaccine for parents who use social media as a health information source. The approach is informed by narrative engagement theory that posits narratives strengthen knowledge and promote engagement through storytelling by tapping into feelings of empathy, identification, and transportation. The investigators will evaluate the efficacy of our Twitter-based pilot intervention in a randomized controlled trial that will enroll 600 parents/caregivers of children ages 9-14, whose child(ren) has not started the vaccine series. Our central hypothesis is that exposure to narrative-focused exemplar messages will lead to greater intention to vaccinate, and subsequently increased rates of vaccination in the intervention group compared to parents in the comparison group, who receive non-narrative HPV vaccine information (i.e., existing HPV vaccine information developed for Twitter). The investigators will use a Twitter-based Community Advisory Board, virtual focus groups, and existing Twitter messages developed by the HPV Roundtable to inform narrative-focused message development. The proposed study will address three specific aims: 1) Develop narrative-focused scientific exemplars for HPV vaccine communication utilizing existing online messages and community engagement on Twitter; 2) Quantify differences in engagement, intention to vaccinate, and self-reported vaccination between parents exposed to the narrative-focused scientific exemplars and parents exposed to non-narrative scientific messages; 3) Collect and analyze longitudinal participant metadata to measure Twitter activity during the study period. This study will impact the field of cancer prevention generally and HPV vaccination specifically by establishing the efficacy of narrative-focused health messaging campaign on social media, using a Twitter-based parent-engagement strategy.

This 4-year study will evaluate the efficacy of a Twitter-based pilot intervention through a randomized controlled trial that will enroll a total of 600 parents/caregivers of children ages 9-14, whose child(ren) has not started the vaccine series. The intervention will consist of 2 arms and 12 monthly cohorts. After enrollment in the project, 300 participants will be randomized into the intervention arm and 300 participants will be enrolled into the control arm. Participants will be presented the intervention one month before their child's next wellcare visit.

Hashtag HPV: HPV Vaccine Twitter Education Program

Hashtag HPV: Engaging Parents Through Social Media to Increase HPV Vaccination

There is not a plan to make IPD available.

dependent variable; measure collects date of vaccination and number of vaccine doses to date

dependent variable; measures readiness and likeliness to receive HPV vaccination

Thomas Jefferson University

University at Albany

National Cancer Institute (NCI)

University of California, Los Angeles

University of Arkansas, Fayetteville

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Antibodies

Immunoglobulins

Immunologic Factors

Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months

Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months

Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses

Gardasil

Neal Halsey, MD

The primary objectives of this study are to determine the acceptance and potential for the effective use of HPV vaccine in the standard and a modified schedule in female sex workers. Secondary objectives include ascertaining the prevalence of HPV types among female sex workers by age and sexual experience.

FSWs are at higher risk of HPV infection and presumably cervical cancer, and the recently available vaccine has been shown to protect against persistent infection from these types. If this study gives evidence showing the vaccine is acceptable in preventing cervical HPV infection by types 16 and 18 in this population, then the burden of cervical cancer and cancer precursors could be drastically decreased through widespread vaccination of this target group. Vaccination at the point of entry of brothel based sex work may become a requirement to lower the burden of cervical cancer among FSWs and also among all other sex partners of clients of FSWs. A modified schedule may prove beneficial for FSWs in Peru to complete the vaccine regimen.

Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers

Acceptability and Feasibility of a Modified HPV Vaccine Schedule in Brothel Based Female Sex Workers in Peru

We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.

Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.

Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.

Listed doubts about the HPV vaccine. Participants were asked if they had any doubts about the vaccine prior to learning about it from the health professional. Herein we present the total number of participants who reported doubts by study arm.

NGO Via Libre

Universidad Peruana Cayetano Heredia

Johns Hopkins Bloomberg School of Public Health

Professor of International Health

Regular Schedule

Modified Schedule

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Peru

Region of Enrollment

Small time difference between study arms (0,2,6 and 0,3,6 months); We cannot distinguish between antibodies resulting from vaccination and antibodies resulting from natural HPV infection;

Dr. Brandon Brown

The null hypothesis is that both schedules will provide an equivalent antibody response.

HPV 6

HPV11

HPV16

HPV18

All participants who returned for the final blood draw considered in the final antibody analysis. The analysis applies to antibody levels after vaccination for HPV6, HPV11, HPV16, and HPV18. This is done for each study arm, namely the regular schedule and the modified schedule.

Antibody Response to HPV Vaccine for HPV 6,11,16,18.

Completion rates compared in the 2 study arms

Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule.

comparison of differences in HPV DNA prevalence by study arm.

All participants were included in the analysis for baseline HPV DNA prevalence

Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers

All participants who listed doubts about the vaccine are counted here.

Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers

Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age

Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers	NCT01087164	Human Papilloma...	Compliance Message sidedne...	11 Years - 15 Years	Indiana University
Hashtag HPV: HPV Vaccine Twitter Education Program	NCT05204030	Human Papilloma... Vaccine-Prevent...	HPV Twitter Edu... HPV Twitter Edu...	18 Years -	University of Arkansas, Fayetteville
Hashtag HPV: HPV Vaccine Twitter Education Program	NCT05204030	Human Papilloma... Vaccine-Prevent...	HPV Twitter Edu... HPV Twitter Edu...	18 Years -	University of Arkansas, Fayetteville
Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers	NCT00925288	Human Papilloma...	Gardasil	18 Years - 26 Years	Johns Hopkins Bloomberg School of Public Health

Spots Global Cancer Trial Database for vaccine acceptance