Self-Sampling Methods for Cervical Cancer

(Unidos Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas at Austin

Disqualifiers: Hysterectomy, Cervical cancer history

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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 6 7 8 9}

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Unidos Contra El VPH (Cancer Vaccine)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Project Vida Health Center El Paso, TX

Who Is Running the Clinical Trial?

University of Texas at Austin Lead Sponsor

Texas Tech University Health Sciences Center, El Paso Collaborator

References

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] Label="Objective" NlmCategory="UNASSIGNED">Cervical cancer is one of the deadliest cancers among women in Latin America and Caribbean (LAC), where most of the countries have not been successful in implementing population-level cytology-based screening programs. An increasing body of evidence supports the validity of self-sampling as an alternative to clinician collection for primary Human papillomavirus (HPV) screening. Therefore, this work aims to summarize recent HPV self-sampling approaches in LAC.

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

[Utilization of self-sampling kits for HPV testing in cervical cancer screening - pilot study]. [2022] To get initial experience with alternative sampling (self-sampling) for HPV testing as the means of cervical cancer screening program.

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

Daily self-sampling for high-risk human papillomavirus (HR-HPV) testing. [2017] Self-sampling for HPV as part of primary screening is a well-tolerated method for women not attending organized Pap smear screening and could increase coverage of cervical cancer screening.

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] Increasing attendance to screening offers the best potential for improving the effectiveness of well-established cervical cancer screening programs. Self-sampling at home for human papillomavirus (HPV) testing as an alternative to a clinical sampling can be a useful policy to increase attendance. To determine whether self-sampling improves screening attendance for women who do not regularly attend the Norwegian Cervical Cancer Screening Programme (NCCSP), 800 women aged 25-69 years in the Oslo area who were due to receive a 2nd reminder to attend regular screening were randomly selected and invited to be part of the intervention group. Women in this group received one of two self-sampling devices, Evalyn Brush or Delphi Screener. To attend screening, women in the intervention group had the option of using the self-sampling device (self-sampling subgroup) or visiting their physician for a cervical smear. Self-sampled specimens were split and analyzed for the presence of high-risk (hr) HPV by the CLART® HPV2 test and the digene® Hybrid Capture (HC)2 test. The control group consisted of 2593 women who received a 2nd reminder letter according to the current guidelines of the NCCSP. The attendance rates were 33.4% in the intervention group and 23.2% in the control group, with similar attendance rates for both self-sampling devices. Women in the self-sampling subgroup responded favorably to both self-sampling devices and cited not remembering receiving a call for screening as the most dominant reason for previous non-attendance. Thirty-two of 34 (94.1%) hrHPV-positive women in the self-sampling subgroup attended follow-up. In conclusion, self-sampling increased attendance rates and was feasible and well received. This study lends further support to the proposal that self-sampling may be a valuable alternative for increasing cervical cancer screening coverage in Norway.

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] Human papillomavirus (HPV) self-sampling (Self-HPV) may be used as a primary cervical cancer screening method in a low resource setting. Our aim was to evaluate whether an educational intervention would improve women's knowledge and confidence in the Self-HPV method.

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] Self-sampling as a method of screening for cervical cancer and its precursors is an attractive option for low-resource settings. However, to allow successful integration of self-sampling into national screening programmes, it is necessary to understand women's perceptions and beliefs surrounding this method of sampling the cervix.

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] Self sampling is considered an adjuvant tool to facilitate the participation of women in cervical cancer screening programmes. This study aimed to evaluate whether cervicovaginal lavage could be an alternative for the cervical smear in cytology and human papillomavirus (HPV) testing and to assess the acceptance of the self sampling device by women.

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] Noninvasive self-sampling is a convenient option that may be highly accepted by women for home-based detection, which could increase the screening rate for cervical cancer (CC) and reduce its incidence and mortality.

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

Human papillomavirus detection for cervical cancer prevention with polymerase chain reaction in self-collected samples. [2019] We studied the usefulness of self-sampling in cervical cancer prevention.