920 Participants Needed

HPV Vaccine and Screening Strategy for Cervical Cancer

Recruiting at 1 trial location
JM
Overseen ByJane Montealegre, M D
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.13678

Who Is on the Research Team?

JM

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.
See 4 more

Exclusion Criteria

Vulnerable Populations
I cannot communicate in English or Spanish.
Lack valid telephone contact information
See 1 more

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?
1Treatment groups
Experimental Treatment
Group I: PRECEDE-PROCEEDExperimental Treatment1 Intervention

Find a Clinic Near You

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.
[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.
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.
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]

Citations

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