100 Participants NeededMy employer runs this trial

HPV Self-Collection Kits for Cervical Cancer

MS
Overseen ByMichelle Silver, PhD, ScM
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Washington University School of Medicine
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 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.12345

Why 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?

MS

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

Self-reports not being screened for cervical cancer within the last 3 years
Has a smartphone
I am between 25 and 65 years old.
See 3 more

Exclusion Criteria

I have been exposed to DES in the past.
Currently pregnant or within 6 weeks of giving birth
I have had cancer of my reproductive organs.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

8 weeks
1 visit (in-person or virtual)

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.

8 weeks

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

Group I: Aim 1: Standard instructions + in-person guidanceExperimental Treatment2 Interventions
Group II: Aim 1: Standard instructionsActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Teal Health, Inc.

Industry Sponsor

Trials
2
Recruited
1,100+

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, ...

Mailed 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 ...

FDA 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 ...