HPV Vaccination Promotion for Young Adults in Texas
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Pregnancy, Life-threatening allergy, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?This clinical trial studies how to improve the human papillomavirus (HPV) vaccination rate in young adults in Texas. This trial aims to learn more about how researchers and health care providers can increase HPV vaccination among college students.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug Gardasil 9 for HPV prevention?
Research shows that the HPV vaccine, including Gardasil 9, is effective in preventing HPV-related diseases like cervical cancer and genital warts. It is recommended for young adults as a catch-up vaccination to protect against HPV infections.
12345Is the HPV vaccine, Gardasil 9, safe for humans?
The HPV vaccine, Gardasil 9, has been shown to be generally safe and well-tolerated in humans, with local reactions like swelling being the most common side effect. It has a safety profile similar to earlier versions of the vaccine, and any adverse events reported are monitored through systems like the Vaccine Adverse Event Reporting System (VAERS).
36789How is the HPV vaccine (Gardasil 9) different from other HPV treatments?
The HPV vaccine, Gardasil 9, is unique because it protects against nine types of HPV, including those responsible for about 90% of cervical cancers and genital warts, unlike earlier versions that covered fewer types. It is administered as a preventive measure, not a treatment for existing infections, and is approved for both males and females.
310111213Eligibility Criteria
This trial is for young adults aged 18-26 in Texas who haven't had the HPV vaccine yet. They must read English, have internet access via a smart device, and be enrolled in a participating school for at least 9 months. Pregnant individuals or those with severe allergies to vaccine ingredients cannot join.Inclusion Criteria
I am between 18 and 26 years old.
I am currently enrolled in a participating school and will be for at least 9 months.
Ability to read and understand English
+2 more
Exclusion Criteria
Being pregnant
Having a life-threatening allergy to any component of the HPV vaccine
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants are randomized to receive various interventions including CDC information, video narratives, written narratives, and enhanced access to vaccination
Varies
Follow-up
Participants are monitored for vaccination initiation and completion rates at 3 and 9 months
9 months
2 visits (virtual)
Participant Groups
The study is testing different ways to increase HPV vaccination rates among young adults using a randomized controlled trial (RCT). Participants will be randomly placed into one of five experimental groups to see which method works best over the course of nine months.
6Treatment groups
Experimental Treatment
Active Control
Group I: Group VI (enhanced access to vaccine, written narratives)Experimental Treatment4 Interventions
Participants receive enhanced access to vaccination and written narratives about HPV vaccination.
Group II: Group V (enhanced access to vaccine, video narratives)Experimental Treatment4 Interventions
Participants receive enhanced access to vaccination and video narratives about HPV vaccination.
Group III: Group IV (enhanced access to vaccine, CDC information)Experimental Treatment4 Interventions
Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.
Group IV: Group III (written narratives)Experimental Treatment3 Interventions
Participants receive written narratives about HPV vaccination.
Group V: Group II (video narratives)Experimental Treatment3 Interventions
Participants receive video narratives about HPV vaccination.
Group VI: Group I (standard CDC information)Active Control3 Interventions
Participants receive standard CDC information about HPV vaccination.
HPV Vaccine is already approved in United States, European Union, Canada, Australia, Switzerland for the following indications:
🇺🇸 Approved in United States as Gardasil 9 for:
- Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11
🇪🇺 Approved in European Union as Gardasil 9 for:
- Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11
🇨🇦 Approved in Canada as Gardasil 9 for:
- Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11
🇦🇺 Approved in Australia as Gardasil 9 for:
- Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11
🇨🇭 Approved in Switzerland as Gardasil 9 for:
- Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Public Health Benefits of Routine Human Papillomavirus Vaccination for Adults in the Netherlands: A Mathematical Modeling Study. [2018]Expanding routine human papillomavirus (HPV) vaccination to adults could be an effective strategy to improve prevention of HPV infection and cervical cancer.
Committee opinion no. 467: human papillomavirus vaccination. [2021]The U.S. Food and Drug Administration has approved both a bivalent and quadrivalent human papillomavirus (HPV) vaccine. The Advisory Committee on Immunization Practices has recommended that HPV vaccination routinely be given to girls when they are 11 years or 12 years old. The vaccine can be given to individuals as young as 9 years; catch-up vaccination is recommended in females aged 13 years through 26 years. The American College of Obstetricians and Gynecologists endorses these recommendations. Although obstetrician-gynecologists are not likely to care for many girls in the initial vaccination target group, they are critical to the catch-up vaccination period. Both HPV vaccines are most effective if given before any exposure to HPV infection (ie, before sexual activity). However, sexually active girls and women can receive some benefit from the vaccination because exposure to all HPV types prevented by the vaccines is unlikely in females aged 13 years through 26 years. Vaccination with either HPV vaccine is not recommended for pregnant women. It can be provided to women who are breastfeeding. The need for booster vaccination has not been established but appears unnecessary. Health care providers are encouraged to discuss with their patients the benefits and limitations of the HPV vaccine and the need for routine cervical cytology screening for those aged 21 years and older.
Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]The nine-valent human papillomavirus vaccine (HPV9, Gardasil®9) was licensed in the USA in December 2014. This study was a multiyear post-licensure study to assess HPV9 safety following routine administration.
"My mom said it wasn't important": A case for catch-up human papillomavirus vaccination among young adult women in the United States. [2018]The human papillomavirus (HPV) vaccine prevents HPV-related diseases, including anogenital cancers and genital warts. In the United States, while it is recommended to adolescents ages 11 to 12, catch-up vaccination is available for those previously unvaccinated until age 26. Parental decisions or lack of provider recommendation during adolescence are barriers to on-time vaccination. Young adult women, ages 18 to 26, are a key catch-up vaccination population as this is a period for autonomous decision-making, high healthcare utilization, and other recommended prevention behaviors. Additional intervention research is required to promote HPV vaccine uptake among young adult women. Evidence-based and theory-informed interventions need to be developed and evaluated to reach a large number of women. In order to improve HPV vaccination among young adult women, future research should integrate the themes of health literacy, alternative healthcare settings, and OB/GYN providers to facilitate improved access and shared decision-making for the vaccine. This last chance for HPV-related cancer prevention should not be forgotten in public health efforts.
Therapeutic human papilloma virus vaccination in patients at risk for cervical dysplasia. [2022]Shared decision making between patients and their healthcare providers is recommended for use of the human papillomavirus (HPV) vaccine Gardasil 9 (9v-HPV) in women ages 27-45 years. We studied HPV vaccination as a treatment modality for patients undergoing colposcopy older than age 26 years who tested positive for high-risk subtypes of HPV (HR-HPV).
Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. [2019]The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age.
Spotlight on the 9-valent HPV vaccine. [2018]Starting in 2006, vaccination against human papillomavirus (HPV) has been progressively implemented in most developed countries. Two vaccines have been successfully used, a bivalent vaccine targeting HPV-related cancers (bHPV) and a quadrivalent vaccine (qHPV) targeting both HPV-related cancers and genital warts. Between December 2014 and June 2015, a new nonavalent HPV vaccine (9vHPV) was granted marketing authorization in the USA and Europe. The 9vHPV was developed from the qHPV and includes five additional HPV types that should increase the level of protection toward HPV-related cancers. Efficacy and/or immunogenicity of 9vHPV has been assessed in eight clinical studies. The 9vHPV vaccine induced a very robust immune response against all vaccine types, with seroconversion rates close to 100%. The safety profile of 9vHPV is comparable to that of qHPV. Local reactions, especially swelling, have been more frequently reported after 9vHPV than qHPV, and this slightly increases when the 9vHPV is coadministered with other vaccines. The additional coverage offered by the 9vHPV may prevent a significant proportion of HPV-related cancers (variable between 8% and 18%) depending on the local distribution of high-risk HPV types in the population. It is impossible, at present, to anticipate the actual impact of the wide use of the 9vHPV in comparison with the bHPV or the qHPV, since it depends on many variables including duration of protection, potential cross-protection toward nonvaccine types, and herd immunity effect.
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]Three licensed human papillomavirus (HPV) vaccines (Cervarix, Gardasil, and Gardasil 9) have been effectively used to prevent infection with oncogenic HPV types; however, many adverse events (AEs) have also been reported following their vaccinations. We assessed AE profiles after receiving the HPV vaccines based on the reported data from Vaccine Adverse Event Reporting System (VAERS).
Human papillomavirus 9-valent vaccine for cancer prevention: a systematic review of the available evidence. [2022]In 2014, the Food and Drug Administration approved a new human papillomavirus 9-valent vaccine (9vHPV), targeting nine HPV types: HPV types 6, 11, 16, and 18, which are also targeted by the quadrivalent HPV vaccine (qHPV), plus five additional high cancer risk HPV types (HPV types 31, 33, 45, 52, and 58). The aim of the current study was to systematically retrieve, qualitatively and quantitatively pool, as well as critically appraise all available evidence on 9vHPV from randomized controlled trials (RCTs). We conducted a systematic review of the literature on 9vHPV efficacy, immunogenicity and safety, as well as a systematic search of registered, completed, and ongoing RCTs. We retrieved and screened 227 records for eligibility. A total of 10 publications reported on RCTs' results on 9vHPV and were included in the review. Sixteen RCTs on 9vHPV have been registered on RCT registries. There is evidence that 9vHPV generated a response to HPV types 6, 11, 16 and 18 that was non-inferior to qHPV. Vaccine efficacy against five additional HPV type-related diseases was directly assessed on females aged 16-26 years (risk reduction against high-grade cervical, vulvar or vaginal disease = 96·7%, 95% CI 80·9%-99·8%). Bridging efficacy was demonstrated for males and females aged 9-15 years and males aged 16-26 years (the lower bound of the 95% CIs of both the geometric mean titer ratio and difference in seroconversion rates meeting the criteria for non-inferiority for all HPV types). Overall, 9vHPV has been proved to be safe and well tolerated. Other RCTs addressed: 9vHPV co-administration with other vaccines, 9vHPV administration in subjects that previously received qHPV and 9vHPV efficacy in regimens containing fewer than three doses. The inclusion of additional HPV types in 9vHPV offers great potential to expand protection against HPV infection. However, the impact of 9vHPV on reducing the global burden of HPV-related disease will greatly depend on vaccine uptake, coverage, availability, and affordability.
Prevention of cervical cancer: journey to develop the first human papillomavirus virus-like particle vaccine and the next generation vaccine. [2022]In 2006, the first human papillomavirus (HPV) virus-like particle (VLP) vaccine was licensed. Gardasil(®), the quadrivalent HPV 6, 11, 16 and 18 recombinant VLP vaccine (4vHPV), developed by Merck demonstrated remarkable efficacy in prevention of important clinical pre-cursors to cervical cancer and genital warts. The vaccine was designed to protect against HPV 16 and 18 that cause ∼70% of cervical cancers and HPV 6 and 11 that cause ∼90% of genital warts. Initially, Gardasil(®) was indicated in the United States for women 9-26 years of age for the prevention of HPV 16 and 18-related cervical, vulvar and vaginal cancer, HPV 6, 11, 16 and 18-related genital intraepithelial neoplasia and the prevention of HPV 6 and 11-related genital warts. Subsequently, a bivalent HPV 16 and 18 VLP vaccine, Cervarix (2vHPV) developed by GlaxoSmithKline was licensed. Since the original licensures, the indications for Gardasil(®) have been expanded to include males and a vaccine with extended HPV coverage, Gardasil 9 (9vHPV), licensed in 2014.
Evaluation of Human Papillomavirus Vaccination After Pharmacist-Led Intervention: A Pilot Project in an Ambulatory Clinic at a Large Academic Urban Medical Center. [2020]Despite the safety and efficacy of the human papillomavirus (HPV) vaccine, many persons are still not receiving it. The purpose of this pilot project was to evaluate the number of first doses of the 9-valent HPV (9vHPV) vaccination administered after a pharmacist-led intervention in the Adult Family Planning Clinic at Grady Health System (GHS), a large academic urban medical center in Atlanta, Georgia.
A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. [2017]A nine-valent human papilloma virus (9vHPV) vaccine has been developed to prevent infections and diseases related to HPV 6/11/16/18 (as per the licensed quadrivalent HPV (qHPV) vaccine) as well as to five additional oncogenic HPV types (HPV 31/33/45/52/58). The 9vHPV vaccine has the potential to prevent 90% of cervical cancers, HPV-related anal, vaginal and vulval cancers and anogenital warts. We compared the immunogenicity and safety of the 9vHPV vaccine versus the qHPV vaccine in 16-26-year-old men.
Human Papilloma Virus Vaccination Knowledge, Prevalence, Risk Factors, and HPV Detection in 18-26 and 27-45-year-old Men and Women. [2023]The US Food and Drug Administration approved a supplemental application for HPV 9-valent vaccine for 27-45-year-old women and men. The Advisory Committee on Immunization Practices did not recommend catch-up vaccination of adults aged 27-45 years, but recognized that some adults who were not previously vaccinated may be at risk for new HPV infection and might benefit from vaccination in this age range. We decided to compare HPV vaccination knowledge, prevalence, risk factors, and history of HPV detection in cohorts with ages of 18-26 and 27-45 years. Men and women aged 18-45 years were asked to complete an anonymous internet survey about HPV infection and vaccination. Valid answers were received from 524 respondents. HPV vaccination rates were low (from 0.00 to 5.56%). All women aged 27-45 years bought the vaccine at their own cost and were vaccinated after sexual debut. Knowledge on existence of the HPV vaccine was better in women (P