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)

Trial Summary

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 data supports the effectiveness of the treatment PRECEDE-PROCEED in the clinical trial for cervical cancer?

Research shows that HPV vaccination, a key component of the treatment strategy, can prevent about 80% of cervical cancer precursors and significantly reduce new cancer cases when combined with screening. This suggests that the treatment could be effective in reducing cervical cancer incidence.12345

Is the HPV vaccine safe for humans?

The HPV vaccines, Gardasil® and Cervarix®, have been studied in over 60,000 women and are considered safe, with ongoing monitoring to ensure their safety. Some adverse events have been reported, but serious ones are rare, and the vaccines are important for preventing cervical cancer.678910

How does the HPV vaccine and screening strategy differ from other treatments for cervical cancer?

The HPV vaccine and screening strategy is unique because it combines vaccination to prevent HPV infections, which cause most cervical cancers, with a risk-based screening approach that reduces the frequency of tests needed. This strategy aims to nearly eradicate cervical cancer by preventing the development of precancerous lesions and reducing unnecessary treatments and anxiety associated with traditional screening methods.24111213

What is the purpose of this trial?

Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.

Research Team

JM

Jane Montealegre

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PRECEDE-PROCEEDExperimental Treatment1 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.

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+

Findings from Research

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

References

Performance of Cervical Screening a Decade Following HPV Vaccination: The Costa Rica Vaccine Trial. [2023]
The impact of HPV vaccination on future cervical screening: a simulation study of two birth cohorts in Denmark. [2018]
Characteristics of 44 cervical cancers diagnosed following Pap-negative, high risk HPV-positive screening in routine clinical practice. [2021]
HPV and cervical cancer. [2015]
Impact of 2-, 4- and 9-valent HPV vaccines on morbidity and mortality from cervical cancer. [2018]
[Human papillomavirus vaccine register]. [2013]
Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far. [2009]
Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. [2019]
[Safety of the bivalent human papillomavirus vaccine--results following administration of more than 192,000 doses]. [2009]
10.United Statespubmed.ncbi.nlm.nih.gov
Invasive and in situ cervical cancer reported to the vaccine adverse event reporting system (VAERS). [2022]
Cervical Cancer Screening Guidelines in the Postvaccination Era: Review of the Literature. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Screening and management of women and girls with human papillomavirus infection. [2022]
[Cervical cancer prevention: the impact of HPV vaccination]. [2007]
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