Self-Sampling Methods for Cervical Cancer

(Unidos Trial)

Overseen By Yanneth Rivera, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Hysterectomy, Cervical cancer history

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

735 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to make cervical cancer screening easier and more comfortable, especially for those who can't easily visit a clinic. It compares three methods: taking a urine sample at home, using a vaginal swab at home, and the traditional Pap smear and HPV test at a clinic. The goal is to determine which method people prefer and which increases screening completion rates. Called Unidos Contra El VPH, this trial suits individuals with a cervix who have not had a Pap test in the last three years and have no history of cervical cancer. As an unphased trial, it offers a unique opportunity to contribute to research that could simplify and improve access to cervical cancer screening.

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 prior data suggests that these self-sampling methods for cervical cancer screening are safe?

Research shows that collecting a urine sample independently to test for HPV is a safe and effective method for cervical cancer screening. Studies have found that individuals can easily and accurately perform this test at home, making it a suitable option for those unable to visit a clinic.

Similarly, using a vaginal swab for self-collection is also safe and effective. Research has confirmed that this method accurately screens for HPV and has received FDA approval. Many prefer this option because it can be done at home, eliminating the need for a clinic visit.

Both methods have undergone testing and approval for self-collection, offering safe and convenient options for cervical cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores self-sampling methods for cervical cancer screening, which could make testing more accessible and convenient. Unlike the traditional in-clinic Pap smear and HPV co-testing, these new methods allow participants to collect samples themselves at home. The urine self-sampling and swab self-sampling methods provide privacy and flexibility, potentially increasing the likelihood of women participating in regular screenings. This could lead to earlier detection and treatment of cervical cancer, ultimately improving health outcomes.

What evidence suggests that these self-sampling methods are effective for cervical cancer screening?

This trial will compare different self-sampling methods for cervical cancer screening. Research has shown that testing for HPV (human papillomavirus) using urine samples, which participants in Group 1 will use, offers a promising alternative to traditional screening methods. Studies indicate that urine tests can identify high-risk HPV types with about 80% accuracy in detecting significant changes in cervical cells, making it a strong option for those who prefer to collect samples at home.

Similarly, participants in Group 2 will use a vaginal swab at home. Research has found this method to be as reliable as traditional exams conducted in a clinic for HPV screening. Self-sampling can effectively identify potential issues and increase screening rates, especially for those who find it difficult to visit a clinic. Both methods provide convenient options for early detection and prevention of cervical cancer. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

The Unidos Contra El VPH study is for individuals who need cervical cancer screening. It's designed to compare the effectiveness of at-home testing methods (using a vaginal swab or urine sample) with traditional in-clinic Pap/HPV co-testing. Participants will be randomly assigned to one of these three groups and will complete surveys about their preferences.

Inclusion Criteria

I am between 30-65 years old and haven't had a Pap test in over three years.

Exclusion Criteria

I have had a hysterectomy.

I have had cervical cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of three cervical cancer screening methods: in-home urine self-sampling, in-home vaginal swab self-sampling, or in-clinic Pap smear and HPV test

8 weeks

1 visit (in-person) for in-clinic group; no visits for in-home groups

Follow-up

Participants complete surveys to assess beliefs and preferences regarding the screening methods

2 weeks

2 surveys (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Unidos Contra El VPH

Trial Overview This trial is testing how well people complete cervical cancer screenings using different methods: self-sampling at home with a vaginal swab, self-sampling at home with urine, or traditional in-clinic Pap/HPV co-testing. The goal is to find out which method has better completion rates and what participants think about each option.

How Is the Trial Designed?

Group I: Group 2: Swab Self-Sampling Experimental Treatment 1 Intervention

Participants in this group receive a kit with a vaginal swab and collection tube to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the sample to the lab.

Group II: Group 1: Urine Self-Sampling Experimental Treatment 1 Intervention

Participants in this group receive a kit with a urine sample cup to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the urine sample to the lab.

Group III: Group 3: In-Clinic Co-Testing Active Control 1 Intervention

Participants in this group are scheduled for an in-clinic Pap smear/HPV co-testing appointment.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Texas Tech University Health Sciences Center, El Paso

Collaborator

Trials

51

Recruited

5,800+

Published Research Related to This Trial

A study involving 215 women showed that self-sampling for HPV testing is effective, with 81% of samples analyzable and a significant detection of high-risk HPV infections in 24% of cases.

The majority of women (98%) reported a positive experience with self-sampling, indicating that this method could increase participation in cervical cancer screening programs and potentially lower the incidence of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Utilization of self-sampling kits for HPV testing in cervical cancer screening - pilot study]. Ondryášová, H., Koudeláková, V., Drábek, J., et al.[2022]

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-sampling for HPV testing significantly increased attendance rates for cervical cancer screening, with 33.4% of women in the intervention group participating compared to 23.2% in the control group, demonstrating its effectiveness as a policy change.

The self-sampling method was well-received by participants, with a high follow-up attendance rate of 94.1% among women who tested positive for high-risk HPV, indicating that self-sampling is a feasible and acceptable alternative to traditional screening methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Sampling for Human Papillomavirus Testing among Non-Attenders Increases Attendance to the Norwegian Cervical Cancer Screening Programme. Enerly, E., Bonde, J., Schee, K., et al.[2022]

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]

An educational intervention significantly improved women's knowledge about HPV and cervical cancer among 302 participants, indicating that tailored information can enhance understanding of health issues.

Despite the increase in knowledge, the intervention did not significantly affect women's confidence or acceptability of the Self-HPV method, suggesting that further research is needed to explore long-term impacts on screening behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an educational intervention on women's knowledge and acceptability of human papillomavirus self-sampling: a randomized controlled trial in Cameroon. Sossauer, G., Zbinden, M., Tebeu, PM., et al.[2021]

In a study involving 7999 women, vulvar specimens showed a higher rate of high-risk HPV (22.32%) compared to cervical specimens (17.38%), indicating that vulvar sampling could be an effective method for detecting HPV related to cervical cancer.

Vulva-based HPV screening demonstrated diagnostic accuracy comparable to traditional cervix-based screening for detecting cervical intraepithelial neoplasia (CIN3+), suggesting it could be a viable option for increasing cervical cancer screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology Characteristics and Potential Clinical Value of Vulvar Human Papillomavirus in Chinese Women: A Multicenter Cross-Sectional Study. Li, X., Xie, H., Fu, Y., et al.[2023]

Self-sampling for HPV detection in cervical cancer screening was found to be less effective than physician-collected samples, with significant differences in results (P < 0.03).

The study revealed that self-sampling missed 50% more cases of cervical cancer compared to physician sampling, indicating that it is not a safe or reliable method for primary cervical cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus detection for cervical cancer prevention with polymerase chain reaction in self-collected samples. Lorenzato, FR., Singer, A., Ho, L., et al.[2019]

HPV self-sampling has been shown to be an effective and acceptable alternative for cervical cancer screening among women in Latin America and the Caribbean, with a review of 20 studies involving 163,787 participants.

This self-sampling method is particularly beneficial for increasing screening rates among underrepresented groups, including rural, indigenous, and transgender women, addressing barriers to access in regions with limited screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent HPV self-sampling use for cervical cancer screening in Latin America and Caribbean: a systematic review. Dartibale, CB., Prado, GC., Carobeli, LR., et al.[2022]

A study involving 25 women (12 premenopausal and 13 postmenopausal) showed that daily self-sampling for high-risk HPV (HR-HPV) resulted in consistent detection of the virus, with 98% of samples showing stable results over the sampling period.

The findings indicate that a single self-sample is reliable for detecting ongoing HR-HPV infections, regardless of the menstrual cycle phase, suggesting that self-sampling could be an effective method for cervical cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily self-sampling for high-risk human papillomavirus (HR-HPV) testing. Sanner, K., Wikström, I., Gustavsson, I., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10046242/

HPV-Based Self-Sampling in Cervical Cancer Screening In conclusion, HPV-based self-collection techniques can effectively address limited uptake alongside other conventional cervical screening ...

2. michiganmedicine.org michiganmedicine.org/health-lab-podcast/self-sampling-hpv-screening-found-be-effective-speculum-exams

Self-sampling for HPV screening found to be as effective as ... Researchers have found that self-sampling is equally reliable to speculum exams for HPV screening in people aged 25 to 65.

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2835169

Self-Collection for Cervical Cancer Screening in a Safety ... Mailed self-collection was effective for increasing CCS in a safety-net health setting; additional modest increases were attained by pairing self-collection ...

4. journals.asm.org journals.asm.org/doi/10.1128/jcm.00767-24

Self-collection for primary HPV screening using dry swabs HPV DNA has been shown to remain stable on self-collected dry swabs even when challenged with extreme temperatures (24). Collectively, these ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352578924001000

Variables that impact HPV test accuracy during vaginal self ... Vaginal self collection (SC) is safe and effective for human papillomavirus (HPV) testing and can increase cervical cancer screening coverage for ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834245

Clinical Validation of a Vaginal Cervical Cancer Screening ... This study found that the SC device is a safe and accurate method for primary HPV cervical cancer screening, offering a preferred alternative to in-clinic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12090030/

Clinical Validation of a Vaginal Cervical Cancer Screening ... This study found that the SC device is a safe and accurate method for primary HPV cervical cancer screening, offering a preferred alternative to ...

8. getteal.com getteal.com/teal-wand

Teal Wand The first FDA-authorized self-collection device for at-home cervical cancer screening in the US, the Teal Wand is an alternative to the in-person Pap smear ...

9. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/fda-hpv-test-self-collection-health-care-setting

HPV Tests with Self-Collection in a Health Setting Approved People can now be offered the option to collect a vaginal sample themselves for HPV testing if they cannot have or do not want a pelvic exam.

10. mdanderson.org mdanderson.org/cancerwise/hpv-tests-with-self-collection-what-to-know.h00-159697545.html

HPV tests with self-collection: What to know The Food and Drug Administration (FDA) recently approved self-collection to test for HPV, the virus that causes cervical cancer.