HPV Vaccine and Screening Strategy for Cervical Cancer

Recruiting at 1 trial location

Overseen By Jane Montealegre, M D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Language barrier, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

920 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore strategies for preventing cervical cancer by encouraging HPV (human papillomavirus) vaccination and improving screening methods. Participants will help researchers understand what influences women's decisions to participate in self-sample HPV testing and follow-up diagnostics. Women aged 25 and older who haven't had a Pap test in the last 3.5 years or a Pap/HPV co-test in the last 5.5 years, and who live in low-resource areas in Texas, might be a good fit.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could shape future cervical cancer prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this screening strategy is safe for cervical cancer prevention?

Research has shown that the PRECEDE-PROCEED model improves health programs, such as those for preventing cervical cancer. Safety is not a primary concern because this model focuses on planning and evaluating health programs, not on testing new drugs or vaccines. It ensures that health programs, like HPV screening, are effective and meet quality standards.

The PRECEDE-PROCEED approach has been used in many health projects, with no direct safety issues reported. Instead, it identifies factors that might encourage or discourage people from using health services like HPV testing. As a method to enhance health strategies rather than a treatment, it carries no known safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to cervical cancer prevention through the PRECEDE-PROCEED model. Unlike traditional methods that focus solely on medical interventions, this strategy looks at the bigger picture by identifying behavioral and environmental factors that influence women's decisions to participate in HPV self-sampling and follow-up diagnostics. This comprehensive approach has the potential to empower women, increase participation in early screening, and ultimately improve cervical cancer prevention outcomes.

What evidence suggests that this trial's treatments could be effective for cervical cancer?

Research has shown that the PRECEDE-PROCEED model, tested in this trial, increases cervical cancer screening. One study found that this model identifies factors that encourage women to participate in HPV testing and follow-up care. Another study demonstrated that educational programs using this model improved women's knowledge and habits for preventing cervical cancer. Additionally, mailing HPV testing kits, guided by this model, increased screening participation. Overall, this approach helps more women get screened, which is crucial for preventing cervical cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Jane Montealegre

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women aged 30 or older living in RGV who haven't had a Pap test in the last 3.5 years or a Pap/HPV co-test in the past 5.5 years, and have not been diagnosed with cervical cancer or severe cervical dysplasia. Participants must be able to understand English or Spanish, are not pregnant, and do not belong to vulnerable populations.

Inclusion Criteria

I am a woman aged 30 or older.

I have not had a hysterectomy that removed my cervix.

Have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years.

Exclusion Criteria

Vulnerable Populations

I cannot communicate in English or Spanish.

Lack valid telephone contact information

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Community-Based Intervention

Community Health Workers (CHW) deliver self-sample HPV testing to increase cervical cancer screening among women

8 weeks

Follow-up

Participants who test positive for HR-HPV are monitored for clinical follow-up and further diagnostic procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PRECEDE-PROCEED

Trial Overview The study tests a community-based strategy called PRECEDE-PROCEED aimed at improving access to cervical cancer screening for early detection of potential disease caused by HPV.

How Is the Trial Designed?

Group I: PRECEDE-PROCEED Experimental Treatment 1 Intervention

To identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study involving 12,066 women aged 9 to 26 years who received the HPV vaccines Gardasil® and Cervarix® over three years, 61% reported experiencing mild and transient adverse events after the first dose.

The high rate of reported adverse events is attributed to the study's design, which encouraged participants to document all occurrences, highlighting the importance of ongoing surveillance for vaccine safety, especially for newly marketed vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. Spila-Alegiani, S., Da Cas, R., Giambi, C., et al.[2013]

The two available HPV vaccines have been shown to be safe and effective in preventing cervical cancer, based on trials involving over 60,000 women before their approval.

Post-licensure surveillance confirms the safety of these vaccines, and ongoing monitoring is essential to ensure continued confidence in their use for women's health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far. Agorastos, T., Chatzigeorgiou, K., Brotherton, JM., et al.[2009]

A review of VAERS reports identified four cases of cervical cancer and three cases of carcinoma in situ among women who received the quadrivalent HPV vaccine, indicating that some cervical cancer cases can still occur post-vaccination.

The findings emphasize the importance of continued cervical cancer screening for vaccinated women, as the vaccine does not eliminate the risk of cervical cancer or precancerous conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Invasive and in situ cervical cancer reported to the vaccine adverse event reporting system (VAERS). Wong, C., Krashin, J., Rue-Cover, A., et al.[2022]

Cervical cancer is the second most common cancer among women, primarily caused by persistent infection with human papillomavirus (HPV), but it is highly preventable through HPV vaccination and effective screening methods.

Shifting to HPV screening for women aged 30 and older could reduce new cervical cancer cases by 70-80%, especially when combined with HPV vaccination, which prevents about 80% of precursor lesions, potentially leading to the near eradication of cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV and cervical cancer. Petry, KU.[2015]

As HPV vaccination rates increase, the prevalence of cervical precancers and cancers is expected to decrease significantly, leading to a need for updated screening guidelines.

New risk-based management guidelines for cervical cancer screening are being developed to reduce the number of tests women undergo while maximizing benefits and minimizing potential harms like overdiagnosis and overtreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical Cancer Screening Guidelines in the Postvaccination Era: Review of the Literature. Liverani, CA., Di Giuseppe, J., Giannella, L., et al.[2023]

Cervical cancer-related mortality in the US has significantly decreased over the past 50 years due to effective screening programs, with guidelines recommending screening to start around age 21 or three years after sexual activity begins.

Combining HPV testing with cytology screening every three years for women aged 30 and older is not only as sensitive as annual screenings but also more cost-effective, highlighting the importance of tailored screening strategies for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and management of women and girls with human papillomavirus infection. Spitzer, M.[2022]

A study of 44 women diagnosed with cervical cancer after a Pap-negative, high-risk HPV-positive screen showed that most cases were early-stage and potentially curable, highlighting the importance of HPV testing in early detection.

The majority of cancers were adenocarcinomas, which are often missed by cytology, suggesting that immediate triage to colposcopy after a Pap-/HPV+ result may be more effective than the current recommendation of retesting in one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of 44 cervical cancers diagnosed following Pap-negative, high risk HPV-positive screening in routine clinical practice. Kinney, W., Fetterman, B., Cox, JT., et al.[2021]

Prophylactic HPV vaccines have shown to provide over 90% protection against persistent HPV 16 and 18 infections, which are responsible for 70% of cervical cancers, with minimal side effects reported in clinical trials.

Vaccination against HPV 16 and 18 could significantly reduce the incidence of abnormal Pap tests by 90% and overall abnormal Pap results by about 50%, potentially decreasing the need for invasive procedures and reducing cervical cancer mortality by over 95%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cervical cancer prevention: the impact of HPV vaccination]. Monsonégo, J.[2007]

In a study of 4632 women aged 25-36, HPV vaccination did not significantly change the sensitivity and specificity of cervical screening methods for detecting high-grade precancers, indicating that vaccinated women still benefit from regular screening.

While HPV-based screening led to lower colposcopy referral rates in vaccinated women, the positive predictive value remained similar between vaccinated and unvaccinated groups, suggesting that non-vaccine HPV types may still contribute to high-grade lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of Cervical Screening a Decade Following HPV Vaccination: The Costa Rica Vaccine Trial. Hu, SY., Kreimer, AR., Porras, C., et al.[2023]

A total of 3174 adverse events (AEs) were reported in children and adolescents aged 6-17 after receiving the HPV vaccine, with 191 (6%) classified as serious.

While these serious AEs raise concerns, further research is necessary to establish a direct link between these events and the HPV vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. Borja-Hart, NL., Benavides, S., Christensen, C.[2019]

HPV vaccination in sexually naïve women is expected to reduce the proportion of positive cervical screening tests from 8.7% to 6.5%, indicating a modest improvement in screening outcomes.

The reduction in false-positive rates is also minimal, decreasing from 5.5% to 4.3% for CIN2+ and from 6.2% to 4.7% for CIN3+, suggesting that while vaccination has benefits, the overall impact on screening effectiveness remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of HPV vaccination on future cervical screening: a simulation study of two birth cohorts in Denmark. Hestbech, MS., Lynge, E., Kragstrup, J., et al.[2018]

In a study involving 192,119 girls aged 13-16, the bivalent HPV vaccine showed a safety profile with no unexpected serious side effects, indicating it is generally safe for this age group.

While side effects were reported, with 92.1% experiencing local effects and 91.7% systemic effects, most were mild and short-lived, aligning with findings from other studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety of the bivalent human papillomavirus vaccine--results following administration of more than 192,000 doses]. van der Maas, NA., Kemmeren, JM., de Melker, HE.[2009]

All three HPV vaccines (bivalent, quadrivalent, and 9vHPV) show high efficacy in preventing infections from specific HPV types and associated high-grade cervical dysplasia in women who have not been previously exposed to HPV.

While the bivalent and quadrivalent vaccines have demonstrated early clinical effectiveness in reducing HPV 16 and 18 prevalence, the overall benefits of HPV vaccination in reducing cervical cancer are still largely theoretical, highlighting the need for large-scale studies to confirm long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of 2-, 4- and 9-valent HPV vaccines on morbidity and mortality from cervical cancer. Luckett, R., Feldman, S.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11506358/

Impact of PRECEDE–PROCEED Model Audits in Cancer ... Results: The 2019 audit showed strengths in participation and quality standards but identified challenges in cervical cancer screening coverage ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04790-5

Mailed self-sample HPV testing kits to improve cervical ... - Trials The aim is to assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among patients ...

3. researchgate.net researchgate.net/publication/367406683_Efficacy_of_precede_model-based_educational_program_on_women's_knowledge_and_practice_regarding_cervical_cancer_prevention

Efficacy of precede model-based educational program on ... Aim: To determine the effect of PRECEDE Model-based educational program on women's Knowledge and practice regarding cervical cancer prevention.

4. digitalcommons.unmc.edu digitalcommons.unmc.edu/cgi/viewcontent.cgi?article=1375&context=coph_slce

Utilizing the Health Belief Model to Design a Community ... The PRECEDE-PROCEED. Model places the goal of increasing cervical cancer screening rates at the heart of project planning. The first four steps comprise the ...

5. liebertpub.com liebertpub.com/doi/10.1089/jwh.2023.0635

A Systematic Review of the Effectiveness of Cervical ... The aim of our review is to evaluate the effectiveness of cervical cancer screening and prevention interventions for African American women living in the United ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7580009/

Mailed self-sample HPV testing kits to improve cervical cancer ... The aim is to assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among patients in a safety net ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0033350622002682

Features of human papillomavirus vaccination education ... We aimed to describe studies on human papillomavirus (HPV) vaccination education strategies from low- and middle-income countries in the published literature

8. researchgate.net researchgate.net/publication/345871584_Mailed_Self-Sample_HPV_Testing_Kits_to_Improve_Cervical_Cancer_Screening_in_a_Safety_Net_Health_System_Protocol_for_a_Hybrid_Effectiveness-Implementation_Randomized_Controlled_Trial

(PDF) Mailed Self-Sample HPV Testing Kits to Improve ... The aim is to assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among patients in a safety net ...