Self-Sampling Device for Cervical Cancer Screening

Recruiting at 15 trial locations

Overseen By Courtney Parsons

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Teal Health, Inc.

Disqualifiers: Hysterectomy, Cervical surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

870 Participants Needed

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. It is best to discuss this with the trial coordinator or your doctor.

What data supports the effectiveness of the Teal Wand Self-Collection Device for cervical cancer screening?

Research shows that self-sampling for cervical cancer screening is highly accepted and increases participation, especially when women receive initial training. This suggests that self-collection devices like the Teal Wand could be effective in encouraging more women to participate in screening. ^{1 2 3 4 5}

Is the self-sampling device for cervical cancer screening safe for humans?

The research articles reviewed focus on the acceptability and feasibility of self-sampling devices for cervical cancer screening, but they do not provide specific safety data. However, the studies suggest that self-sampling is generally well-accepted by women, which may imply a level of safety and comfort with the method. ^{2 4 6 7 8}

How does the self-sampling device for cervical cancer screening differ from other treatments?

The self-sampling device for cervical cancer screening is unique because it allows women to collect their own samples at home, making it more convenient and accessible compared to traditional methods where a healthcare provider collects the sample. This approach can increase participation in screening programs, especially in low-resource settings or for women who are unscreened. ^{8 9 10 11 12}

What is the purpose of this trial?

The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays. Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.

Eligibility Criteria

This trial is for women aged 25-65 with an intact cervix, who can consent to participate. It includes those previously diagnosed with high-risk HPV or abnormal Pap results within the last 6 months, and those undergoing certain cervical procedures.

Inclusion Criteria

Group 2: Inclusion Criteria - Enriched Population Group

I have an intact cervix.

I am between 25 and 65 years old and agree to participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Self-Collection and Clinician Collection

Participants use the Teal Wand for self-collection followed by a healthcare provider collection for hrHPV testing

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sample collection

2 weeks

1 follow-up contact (virtual or phone)

Treatment Details

Interventions

• Teal Wand Self-Collection Device

Trial Overview The study compares the effectiveness of a self-collection device called Teal Wand for detecting high-risk HPV (hrHPV) against samples collected by healthcare providers using standard HPV testing methods.

Participant Groups

Group I: Self-Collection / Clinician Collection Experimental Treatment 1 Intervention

Patient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection.

Who Is Running the Clinical Trial?

Teal Health, Inc.

Lead Sponsor

Trials

2

Recruited

1,100+

Findings from Research

A study involving 822 women in South Africa found that most participants had a positive attitude towards self-sampling for cervical cancer screening, with 93.6% not feeling embarrassed and 89.4% reporting no discomfort during the process.

Despite their positive perceptions, 64.7% of women felt more confident when samples were taken by clinicians, mainly due to concerns about the quality of self-collected samples and the financial burden of returning to the clinic with the sample.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

South African women's perspectives on self-sampling for cervical cancer screening: A mixed-methods study. Saidu, R., Moodley, J., Tergas, A., et al.[2019]

Self-collected cervicovaginal lavage for HPV testing showed high concordance (93%) with results from traditional cervical smears, indicating it could be a reliable alternative for cervical cancer screening.

While 88% of women found the self-sampling device acceptable, the concordance for cytology results was lower (54% with doctor and 41% with patient), suggesting that self-sampling is more effective for HPV testing than for cytology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary screening for high risk HPV by home obtained cervicovaginal lavage is an alternative screening tool for unscreened women. Nobbenhuis, MA., Helmerhorst, TJ., van den Brule, AJ., et al.[2022]

Cervicovaginal self-sampling using the Evalyn Brush for hr-HPV testing showed a 97.5% agreement with physician-collected samples, indicating it is a reliable method for detecting high-risk HPV.

The self-sampling method identified hr-HPV in 93.5% of patients with cervical intraepithelial neoplasia grade 3 or worse, demonstrating its effectiveness in identifying significant cervical disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. Chen, K., Ouyang, Y., Hillemanns, P., et al.[2017]

References

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

Clinician and Patient Acceptability of Self-Collected Human Papillomavirus Testing for Cervical Cancer Screening. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Self-sampling in cervical cancer screening: comparison of a brush-based and a lavage-based cervicovaginal self-sampling device. [2022]

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

HPV self-sampling among cervical cancer screening users in Spain: A randomized clinical trial of on-site training to increase the acceptability. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Acceptability of human papillomavirus self-sampling for cervical-cancer screening in under-screened Māori and Pasifika women: a pilot study. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Preferences and Experiences Regarding the Use of the Self-Sampling Device in hrHPV Screening for Cervical Cancer. [2022]

6. Thailand pubmed.ncbi.nlm.nih.gov

Self-collection tools for routine cervical cancer screening: a review. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Understanding the Acceptability and Uptake of HPV Self-Sampling Amongst Women Under- or Never-Screened for Cervical Cancer in Toronto (Ontario, Canada): An Intervention Study Protocol. [2021]

8. South Africa pubmed.ncbi.nlm.nih.gov

South African women's perspectives on self-sampling for cervical cancer screening: A mixed-methods study. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Primary screening for high risk HPV by home obtained cervicovaginal lavage is an alternative screening tool for unscreened women. [2022]

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

Validation of a new HPV self-sampling device for cervical cancer screening: The Cervical and Self-Sample In Screening (CASSIS) study. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. [2017]

12. New Zealand pubmed.ncbi.nlm.nih.gov

A comparison of cotton and flocked swabs for vaginal self-sample collection. [2022]