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?

The purpose of the Unidos Contra el VPH study is to help find options to screen, or check, for cervical cancer that individuals can do at home to help prevent and detect cervical cancer early. Usually, people get screened for cervical cancer with a Pap smear and human papillomavirus (HPV) test by a health care provider. This is not always easy for individuals who are not able to get to a clinic or feel uncomfortable having the procedure done. That is why we want to find other ways that may be easier and more comfortable for people to be screened for cervical cancer. The two main questions the study aims to answer are: 1. How do the following three cervical cancer screening methods compare for improving screening completion rates? o In-home HPV self-sampling with a vaginal swab * In-home HPV self-sampling with urine testing * In-clinic traditional Pap smear with HPV test 2. What are participant beliefs and preferences regarding these three screening methods? Participants in the study will be randomly assigned to one of three groups. This means each person has an equal chance of being placed in any group. They will also complete two surveys as part of the study. The three screening method groups are described below: Group 1: Urine Self-Sampling * Participants in this group will 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 2: Vaginal Swab Self-Sampling o Participants in this group will 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 3: In-Clinic Screening * An in-clinic co-testing appointment is scheduled for a Pap smear and HPV test done together at Project Vida Health Center. By comparing these approaches, this study aims to improve access to cervical cancer screening and provide better options for those who face barriers to clinic-based 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.

How is the Unidos Contra El VPH treatment different from other cervical cancer treatments?

Unidos Contra El VPH is unique because it involves self-sampling methods for cervical cancer screening, allowing women to collect samples at home, which can increase participation in screening programs, especially in low-resource settings. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Unidos Contra El VPH for cervical cancer?

The research shows that self-sampling for HPV testing increases attendance for cervical cancer screening, which is crucial for early detection and treatment. This method is well-received and effective in reaching women who might not otherwise participate in regular screenings. ^{5 6 7 8 9}

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

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 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 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]

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]

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]

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]

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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Recent HPV self-sampling use for cervical cancer screening in Latin America and Caribbean: a systematic review. [2022]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

[Utilization of self-sampling kits for HPV testing in cervical cancer screening - pilot study]. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Daily self-sampling for high-risk human papillomavirus (HR-HPV) testing. [2017]

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

Self-Sampling for Human Papillomavirus Testing among Non-Attenders Increases Attendance to the Norwegian Cervical Cancer Screening Programme. [2022]

5. United States 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. [2021]

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

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

7. 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]

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

Epidemiology Characteristics and Potential Clinical Value of Vulvar Human Papillomavirus in Chinese Women: A Multicenter Cross-Sectional Study. [2023]

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

Human papillomavirus detection for cervical cancer prevention with polymerase chain reaction in self-collected samples. [2019]