Mailed HPV Self-Sampling Kits for Cervical Cancer Screening

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: No valid phone, Non-English/Vietnamese/Spanish, Pregnant, Cervical dysplasia, others

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

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

Trial Summary

What is the purpose of this trial?

Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.

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.

What data supports the effectiveness of the treatment Mailed HPV Self-Sampling Kit for cervical cancer screening?

Research shows that mailing HPV self-sampling kits can increase participation in cervical cancer screening, especially among women who are overdue for screening. This approach helps overcome barriers to clinic-based screening and has been found to be cost-effective in some international settings. ^{1 2 3 4 5}

Is the Mailed HPV Self-Sampling Kit safe for use in humans?

The Mailed HPV Self-Sampling Kit is generally considered safe for use, as it has been used by thousands of people without significant safety issues reported. The process is simple and efficient, with a high rate of successful sample collection and return. ^{1 4 6 7 8}

How does the Mailed HPV Self-Sampling Kit treatment differ from other cervical cancer screening methods?

The Mailed HPV Self-Sampling Kit allows women to collect samples at home for HPV testing, which can increase participation in cervical cancer screening by overcoming barriers like clinic visits. This approach is unique because it provides a convenient, private alternative to traditional in-clinic Pap smears, potentially improving screening rates among women who might otherwise not participate. ^{1 2 4 9 10}

Eligibility Criteria

This trial is for Asian and Asian American women who find it difficult or unacceptable to attend regular Pap test screenings in a clinic. It aims to increase cervical cancer screening participation among underserved minority women within a safety-net health system.

Inclusion Criteria

Be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months

No Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years

Patient of Harris Health System in Harris County (Houston), Texas

Exclusion Criteria

No valid telephone contact information

Currently pregnant

I have had cervical dysplasia in the last 3.5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a scripted telephone recall and may receive mailed self-sampling kits for HPV testing

6 months

Telephone contact and mail interaction

Follow-up

Participants are monitored for screening test results and clinical follow-up

12 months

Treatment Details

Interventions

• Mailed HPV Self-Sampling Kit

Trial Overview The PRESTIS trial is testing whether mailing self-sampling kits for HPV can effectively encourage more frequent screening for cervical cancer, compared to traditional methods like telephone recalls or patient navigation services.

Participant Groups

Group I: Mailed HPV Self-Sampling Kit + Patient Navigation Experimental Treatment 3 Interventions

Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.

Group II: Mailed HPV Self-Sampling Kit Experimental Treatment 2 Interventions

Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a prepaid return envelope

Group III: Telephone Recall Active Control 1 Intervention

Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

Over half of the 233 women surveyed reported discomfort with traditional clinic-based cervical cancer screenings, citing feelings of embarrassment and discomfort with male providers, particularly among Spanish speakers.

The majority of women who used the at-home HPV self-sampling kits found them to be less embarrassing, less stressful, and more convenient than traditional Pap tests, suggesting that these kits could effectively reduce barriers to screening for under-screened populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey. Parker, S., Deshmukh, AA., Chen, B., et al.[2023]

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]

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]

References

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

Economic Evaluation of Mailed Home-Based Human Papillomavirus Self-sampling Kits for Cervical Cancer Screening. [2023]

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

Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program. [2022]

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

Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Women's experience with home-based self-sampling for human papillomavirus testing. [2018]

6. China pubmed.ncbi.nlm.nih.gov

[Construction and application of home self-sampling processes for cervical human papillomavirus detection]. [2021]

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

Acceptability and Feasibility of Human Papilloma Virus Self-Sampling for Cervical Cancer Screening. [2023]

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

Randomized Comparison of Two Vaginal Self-Sampling Methods for Human Papillomavirus Detection: Dry Swab versus FTA Cartridge. [2018]

9. 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]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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