HPV Self-Collection Kits for Cervical Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to simplify cervical cancer screening for women by using at-home HPV self-collection kits. Researchers seek to determine the most effective method for distributing these kits to women who haven't been screened in the last three years. Participants will receive either standard instructions or standard instructions with additional in-person guidance. Women aged 25 to 65, who haven't had a cervical cancer screening in the last three years and have a smartphone with internet access, may be suitable for the trial. As an unphased trial, this study provides a unique opportunity to enhance accessibility to cervical cancer screening.
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. It seems focused on cervical cancer screening, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.
What prior data suggests that HPV Self-Collection Kits are safe for cervical cancer screening?
Research shows that HPV self-collection kits are safe and effective for cervical cancer screening. Studies have found these kits to be as accurate as the traditional method where a doctor collects the sample. They reliably detect high-risk types of HPV linked to cervical cancer.
The FDA has approved some of these kits, enhancing confidence in their safety and effectiveness. Reports indicate that most people find the self-collection process easy, with over 97% feeling comfortable using it. No major safety issues have been reported, indicating the kits are well-tolerated.
These kits not only help identify high-risk HPV but also make testing more accessible, especially for those who might avoid clinic visits. Overall, studies support using HPV self-collection kits as a safe option for cervical cancer screening.12345Why are researchers excited about this trial?
Researchers are excited about the HPV self-collection kits for cervical cancer because they offer a unique approach that empowers individuals to collect samples themselves at home. Unlike traditional methods, which require a visit to a healthcare provider for a Pap smear or HPV test, these kits provide a more convenient and private alternative. This method could increase screening rates by making it easier for people to participate in regular testing, especially in underserved communities. The trial is also exploring whether adding in-person guidance makes this process even more effective, potentially improving user confidence and test accuracy.
What evidence suggests that HPV Self-Collection Kits are effective for cervical cancer screening?
This trial will evaluate the effectiveness of HPV self-collection kits for cervical cancer screening. Studies have shown that these kits increase screening rates, particularly among those who don't get regular check-ups. Research indicates that women using these kits are twice as likely to get screened. These kits are also cost-effective, offering good value for the money spent. Additionally, self-collection accurately and reliably detects HPV, the virus that can cause cervical cancer. Overall, evidence supports that self-collection kits can help catch potential issues early and improve health outcomes. Participants in this trial will receive either standard instructions or standard instructions with in-person guidance to assess the impact on screening rates.56789
Who Is on the Research Team?
Michelle Silver, PhD, ScM
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for women ages 25-65 who haven't had cervical cancer screening in the past 3 years, have a smartphone and internet access, can use English well, and still have their cervix. People with certain health conditions or recent pregnancy can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive at-home HPV testing kits and complete a sociodemographic questionnaire. They receive either standard instructions or standard instructions with in-person guidance.
Follow-up
Participants are monitored for the return of HPV samples and participate in qualitative interviews to assess thematic findings related to capability, opportunity, motivation, and behavior.
What Are the Treatments Tested in This Trial?
Interventions
- HPV Self-Collection Kits
Trial Overview
The study is testing different ways to give at-home HPV self-collection kits for cervical cancer screening. It compares virtual instructions alone versus virtual plus in-person help, using interviews and mobile app support.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will complete a sociodemographic questionnaire and will receive the standard instructions and in-person navigation for registering for a consult to receive the at-home testing kit. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.
Participants will complete a sociodemographic questionnaire and will receive the standard instructions. After approximately 8 weeks, participants will be asked to participate in the qualitative interview.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Teal Health, Inc.
Industry Sponsor
Citations
Cost-effectiveness of human papillomavirus (HPV) self ... - PMC
Our findings show that employing HPV self-collection was both affordable and effective in increasing cervical cancer screening uptake among underscreened, ...
2.
mdanderson.org
mdanderson.org/newsroom/mailed-self-collection-hpv-tests-boost-cervical-cancer-screening.h00-159777234.htmlMailed self-collection HPV tests boost cervical cancer ...
Real-world study found self-collection tests were effective at increasing cervical cancer screening participation in underserved U.S. ...
Cost-Effectiveness of HPV Self-Testing Options for Cervical ...
This economic evaluation examines the cost-effectiveness of mailed human papillomavirus (HPV) self-sampling kits among members of a US ...
Effect of HPV self-collection kits on cervical cancer ...
Mailed HPV self-collected samples have the potential for even greater effects if the US Food and Drug Administration approve them for primary ...
Self‐collected vaginal specimens for human papillomavirus ...
When clinician-collected cervical specimens are used for HPV testing, repeat screening is recommended every 5 years for those with a negative ...
summary of safety and effectiveness data (ssed)
This test identifies high-risk (HR) HPV types 16, 18, 45, while reporting the concurrent detection of the other HR genotypes (31/33/52/58) and ( ...
Self-Collection for Cervical Cancer Screening in a Safety-Net ...
Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness ...
Clinical Validation of a Vaginal Cervical Cancer Screening ...
Meaning This study found that the SC device is a safe and accurate method for primary HPV cervical cancer screening, offering a preferred ...
9.
contemporaryobgyn.net
contemporaryobgyn.net/view/fda-clears-onclarity-hpv-self-collection-kit-approves-bd-onclarity-hpv-assay-cervical-cancer-screeningFDA clears Onclarity HPV self-collection kit, approves BD ...
The FDA cleared the Onclarity HPV Self-Collection Kit, allowing patients to collect samples at home for processing via the FDA-cleared BD ...
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