HPV Self-Collection for Human Papillomavirus

Recruiting in Palo Alto (17 mi)

Overseen by Deanna Kepka, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Utah

Disqualifiers: No cervix, Hospice, Palliative, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The objective of the study is to develop, pilot, and analyze the effectiveness of HPV self-collection programs which will be used to follow up among women overdue for cervical cancer screening. The investigators will develop protocols for in-clinic and home-based HPV-self-collection programs and follow-up system for HPV-positive tests for community health centers and/or clinics. The program is meant to mail HPV-self-collection kits to women who are due and/or overdue for cervical cancer screening and the program is also meant to present women seen in clinic with a self-collection option for screening alongside a Pap test option. The research team will develop related informational resources on how to complete the test as well as information on screening options. The study will neither experiment nor test the effectiveness of the self-collection process nor the assay of specimens for HPV and high-risk HPV strains. It is not a clinical investigation to assess the safety or effectiveness of a medical device. The study is implementation science and seeks to find optimal ways to implement this World Health Organization recommended screening option.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on screening methods rather than medication use.

What data supports the effectiveness of the treatment HPV Self-Collection for Human Papillomavirus?

Research shows that HPV testing on self-collected samples is as effective as testing on samples collected by healthcare providers. It is well accepted by patients, cost-effective, and can increase screening rates for cervical cancer.

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Is HPV self-collection safe for humans?

The research does not specifically address safety concerns, but HPV self-collection is generally considered safe as it involves collecting a sample from the body without invasive procedures.

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How does HPV self-collection differ from other treatments for HPV detection?

HPV self-collection allows individuals to collect their own samples at home for HPV testing, which can be more convenient and accessible compared to traditional methods where a clinician collects the sample during a pelvic exam. This method can help increase participation in cervical cancer screening by reducing barriers such as the need for a clinical visit.

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Eligibility Criteria

The HPV Self-Collection Program is for women and individuals with a cervix, aged 24-64 who haven't had a Pap test in the last 3.5 years or those aged 30-65 without an HPV test in the past 5.5 years. Participants must be overdue for cervical cancer screening and have visited a participating clinic.

Inclusion Criteria

Qualifying visit to the participating clinic

I am between 25 and 65 years old.

I have missed my scheduled cervical cancer screening.

Exclusion Criteria

I do not have a cervix.

I am receiving comfort care for my illness.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of HPV self-collection program at clinics and homes, including protocol development and educational material distribution

12 months

Ongoing visits as needed for implementation

Follow-up

Participants with positive HPV tests are followed up for recommended care and further evaluation

12 months

Evaluation

Evaluation of the HPV self-collection program effectiveness, including surveys and interviews with healthcare team members and analysis of patient-level data

12 months

Participant Groups

This study aims to evaluate the effectiveness of mailing out HPV self-collection kits to women overdue for cervical cancer screening and offering them as an option at clinics. It focuses on implementing these programs rather than testing medical devices or safety.

Group I: HPV Self-Collection Experimental Treatment 1 Intervention

Patients at partnering clinics who are enrolled in the clinics' HPV self-collection program(s). The requirements for being enrolled in the program are based off of the American Cancer Society's recommendation for cervical cancer screening.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences Salt Lake City, UT

Who Is Running the Clinical Trial?

University of Utah Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

HPV self-collection: what are we waiting for? Exploration of attitudes from frontline healthcare providers. [2023] Polymerase chain reaction based human papilloma virus (HPV) self-collection for cervical cancer screening is well established. It is utilized worldwide, accepted by patients, is cost-effective, has comparable sensitivity to provider-collected samples, and increases screening rates, however clinical practice in the United States has not shifted to include HPV self-collection. This study sought to examine provider knowledge and attitudes to better understand why HPV self-collection is not being utilized.

2. United States pubmed.ncbi.nlm.nih.gov

Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing. [2022] Self-collected human papillomavirus (HPV) testing could reduce barriers to cervical cancer screening, with performance comparable to clinician-collected specimens. The ability of self-collected specimens to cross-sectionally and prospectively detect precursor lesions was investigated in an HPV vaccine randomized trial in Costa Rica.

3. Germany pubmed.ncbi.nlm.nih.gov

[Self-collection of test material. Supplement to cervical cancer screening]. [2022] Recent studies have reported high sensitivity of human papillomavirus (HPV) testing from self-collected vaginal specimens. These results suggest the possibility of introducing self-collection of samples for cervical cancer screening to increase overall participation. The current study compared test results from self-collected and physician-collected specimens.

4. England pubmed.ncbi.nlm.nih.gov

Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial. [2022] Human papillomavirus (HPV) testing on self-collected samples is a potential alternative to HPV testing on clinician-collected samples, but non-inferiority of its clinical accuracy remains to be assessed in the regular screening population. The IMPROVE study was done to evaluate the clinical accuracy of primary HPV testing on self-collected samples within an organised screening setting.

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of the applicability of internal controls on self-collected samples for high-risk human papillomavirus is needed. [2023] Self-collection of cervical samples to detect high-risk human papillomavirus (hr-HPV) is a trending topic in primary cervical cancer screening. This study evaluates the applicability of a self-sampling device to routine molecular procedures for hr-HPV detection.

6. Australia pubmed.ncbi.nlm.nih.gov

Accuracy of self-collected human papillomavirus samples from Japanese women with abnormal cervical cytology. [2017] The aim of this study was to assess the accuracy of self-collected vaginal samples compared with physician-collected cervical samples for high-risk human papillomavirus (HPV) testing in Japanese women with abnormal cervical cytology. We also assessed the acceptability of self-collected HPV (sHPV) testing using a questionnaire.

7. England pubmed.ncbi.nlm.nih.gov

Clinical performance of high-risk HPV testing on self-samples versus clinician samples in routine primary HPV screening in the Netherlands: An observational study. [2022] High-risk human papillomavirus (hrHPV) testing on self-collected samples has potential as a primary screening tool in cervical screening, but real-world evidence on its accuracy in hrHPV-based screening programmes is lacking.

8. United States pubmed.ncbi.nlm.nih.gov

Collection devices for human papillomavirus. [2006] Human papillomavirus (HPV) testing has relied to date on samples collected by experienced health professionals. Self-administered testing devices could allow HPV testing to occur in large-scale epidemiologic studies of primary care screening populations. The purpose of this study is to determine whether a self-collection device for cervicovaginal HPV infection could be developed.

9. United States pubmed.ncbi.nlm.nih.gov

Cervical Human Papillomavirus Testing With Two Home Self-Collection Methods Compared With a Standard Clinically Collected Sampling Method. [2020] The purpose of this study was to compare the outcomes of 2 self-collection methods to detect cervical human papillomavirus (HPV) DNA with outcomes from a standard clinical method. The standard method samples were collected by a clinician at a routine pelvic examination. Self-samples were taken at home and mailed to the clinical laboratory.