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Vaccines

Patients at study clinics who consent to have their HPV vaccination history verified with the Georgia Registry of Immunization Transactions and Services (GRITS).

The background HPV update rate among PLWH will be obtained by using the electronic medical record (EMR) and GRITS to identify HPV vaccination uptake 18 months prior to the intervention. These data are collected retrospectively and no study participants are prospectively assigned to this study arm.

The CDC's 4 Pillars Transformation Program (4 Pillars Program) is a robust and empirically supported strategic approach that promotes the uptake of adult vaccinations and addresses facilitators and barriers at the patient, provider, and clinic level. This multi-level, evidence-based intervention has been successfully utilized to increase HPV vaccination in the general population and is primed to be tested in the high-risk HIV population, particularly PLWH in the rural South. This proposal seeks to expand the success of the 4 Pillars Program and tailor, refine, and implement in the HIV positive population who are at extraordinarily high risk for HPV-related cancers and can obtain the most benefit from the vaccine.

CDC 4 Pillars Program

Jessica Wells, PhD, RN

Robert Knott

Jessica Wells, PhD

People living with HIV (PLWH) are 28 times more likely to be diagnosed with Human Papillomavirus (HPV) - associated anal cancer than the general population. The HPV vaccine is an effective and safe approach to prevent and reduce the risk of HPV-related disease among PLWH. HPV vaccine programs tailored and implemented in the HIV population are lagging for this high-risk group. The CDC's 4 Pillars Transformation Program is a multi-level, evidence-based intervention that has been successfully used to increase HPV vaccination in the general population and is ready to be tested in the high-risk HIV population, particularly PLWH in the rural South. This program offers providers and clinic staff evidence-based strategies to increase HPV vaccination uptake via training and educational resources. This study proposes to tailor and refine the 4 Pillars Program and do this project in three HIV clinics in Georgia (AID Atlanta, AID Newnan, and Albany Model Rural HIV Clinic) and enroll n=365 PLWH who are age 18-45 years from those clinics.

People living with HIV (PLWH) are 28 times more likely to be diagnosed with HPV- associated anal cancer than the general population. The HPV vaccine is an effective and safe approach to prevent and reduce the risk of HPV-related disease among PLWH. However, in previous pilot studies, there were significant gaps found in knowledge and awareness of the HPV vaccine as well as low receipt of the HPV vaccine (13.5%) in our population of rural PLWH.

HPV vaccine programs tailored and implemented in the HIV population are lagging for this high-risk group. The Center for Disease Control's (CDC) 4 Pillars Transformation Program is a multi-level, evidence-based intervention successfully used to increase HPV vaccination in the general population and is ready to be tested in the high-risk HIV population, particularly PLWH in the rural South. Thus, this study proposes to tailor and refine the 4 Pillars Program and do this project in four HIV clinics in Georgia (AID Atlanta, AHF Midtown, AHF Lithonia, and Albany Model Rural HIV Clinic).

The 4 Pillars Program offers providers and clinic staff evidence-based strategies to increase HPV vaccination uptake via training and educational resources. Providers and clinic staff interested in participating will "enroll" online and complete an electronic informed consent before participating in the focus groups and completing the evaluation surveys. Providers and clinic staff will be offered an opportunity to participate in in-service training (CE units will be available) that will provide education and resources on the 4 Pillars program and will learn more about HPV, HPV vaccination, and HPV-associated cancers. Providers and clinic staff will be asked to recommend and administer the HPV vaccine during each routine clinic visit. Consenting providers and clinic staff will be asked to complete pre-intervention evaluations, an intervention evaluation every 3 months, a post-evaluation, and post-intervention evaluations.

For patient enrollment, the research coordinator, with assistance from a clinic-designated Immunization Champion (IC), will review the clinic's appointment schedule to call patients in the target age range (18- 45 years of age) one week in advance of their appointments to inform them of the study and to determine eligibility. If eligible and interested in the proposed study, the individual will be given an overview of the research study, including its purpose, what participation entails, potential risks and benefits of participation, and measures that will be used to ensure confidentiality. Participants will be assured participation is completely voluntary and they may withdraw from the study at any time without consequences. If the individual volunteers to participate in the study, an electronic informed consent will be obtained by the research assistant(s) via REDCap. Participants will be asked to consent to have their HPV vaccination status confirmed via electronic medical records and GRITS. Participants will then watch a short video on HPV and HPV vaccines that can be viewed on their phones (or the clinic's iPad) while waiting to be seen. Potential participants will be asked to "follow" the study's private Facebook page which will offer additional educational information tailored towards individuals with HIV on HPV-related disease and general health promotion and risk reduction tips. A post-intervention evaluation will be provided after the third immunization is given or due (if missed).

The study will be implemented at the clinic, Provider, and Patient levels. Every level will receive a different intervention or none in the case of the control. Clinic and Provider level will receive training on recommending and administering the vaccine at the clinic. Patient level will accept or decline the recommendation for the HPV vaccine. The Control arm will be collected from EMR and the GRITS database from patients not receiving the vaccine before the intervention period.

Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study

Implementing an Evidence-Based, Multilevel Intervention to Promote HPV Vaccination Among HIV Positive Adults

Individual data that underlie the results of the study's specific aims. All reported data including text, tables, figures, and appendices will be de-identified.

Initiation of the HPV vaccine is defined as receiving the first or second immunization from the series. This variable will be measured by electronic medical records and GRITS at 24 months post baseline.

Completion is defined as receiving all 3 immunizations from the series, regardless of time. This variable will be measured by electronic medical records and GRITS 24 months post baseline.

The team will calculate the percent change in initiation of the vaccine and percent change in completion of the vaccine from the control phase and 24 months post intervention, after adjusting for demographics differences in population.

National Institute of Nursing Research (NINR)

Emory University

Assistant Professor

Symptoms and General Pathology

Vaccine-Preventable Diseases

Communicable Diseases

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

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Those getting Gardasil vaccination for low grade Pap abnormality.

Historical group that did not get Gardasil.

Subjects are those getting gradasil vaccination already. This is really not an intervention

human papillomavirus vaccine L1, type 6,11,16,18

Dean A. Seehusen, MD, MPH

This project will compare the rate of regression of minimally abnormal Pap smears to normal in women who receive Gardasil to a historical control group.

Research hypothesis: Women with low grade cervical dysplasia on Papanicolaou (Pap) smear that receive Gardasil vaccination will revert to a normal within one year at a rate 33% higher than historical controls that did not receive Gardasil vaccination.

This study is looking for additional clinical outcomes in women who are already getting the Gardasil vaccination. We are not giving the vaccination as part of the research protocol. This point will be stressed to patients. Their participation or non-participation will not impact their ability to receive the vaccine series. Their participation only impacts whether or not we will contact them in the future and whether or not we will review their medical records.

Subjects will be enrolled into the study at the time of their presentation for colposcopy in the EAMC Family Medicine Clinic. Subjects will be screened for inclusion and exclusion criteria. Those found eligible will be consented for enrollment by one of the study investigators. Colposcopy records will also be searched for patients seen in the colposcopy clinic between the availability of Gardasil and the beginning of this study. Any patients who meet enrollment criteria will be contacted by phone and invited to participate in the study. These patients will be followed in the exact same way as patients enrolled upon presenting for the first time to the colposcopy clinic.

Patients will be given their first vaccination at the time of their colposcopy appointment unless they have already begun the vaccine series. Phone and email will be used to remind patients when they are due for their second and third vaccinations. Any study subject that does not receive the their 2nd or 3rd vaccine will be considered "partially vaccinated". They will not be removed from the protocol, however, because an intention-to-treat analysis is planned.

Study subjects will be followed prospectively for up to 15 months. 15 months was chosen because some patients may be late getting their one-year follow ups. AHLTA records and colposcopy clinic convenience files will be reviewed for each patient periodically. Patients who meet criteria to return to routine annual Pap smear, based on ASCCP guidelines, during the next 11 to 15 months will be considered as "reversion". Those patients who have ASCUS, + HPV, LGSIL, or HGSIL on Pap smear at 11 to 15 months past their original Pap smear will be considered "persistent". Historical control subjects will also be grouped into "reversion" and "persistent" using the same criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study	NCT05065840	Human Papilloma... Human Papilloma...	CDC 4 Pillars P...	18 Years - 45 Years	Emory 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
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities	NCT00501189	Papillomavirus ...	human papilloma...	18 Years - 26 Years	Eisenhower Army Medical Center
Advancing HPV Vaccination Among HIV Positive Adults: The CHAMPS Study	NCT05065840	Human Papilloma... Human Papilloma...	CDC 4 Pillars P...	18 Years - 45 Years	Emory University
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities	NCT00501189	Papillomavirus ...	human papilloma...	18 Years - 26 Years	Eisenhower Army Medical Center

Spots Global Cancer Trial Database for human papilloma virus vaccine