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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to make cervical cancer screening easier and more accessible by sending HPV self-sampling kits to participants. It focuses on Asian and Asian American women who might find it hard to attend regular Pap tests at a clinic. The study tests whether these mailed kits, combined with patient support calls, can boost screening rates in underserved communities. Asian individuals who have not had a recent Pap or HPV test and are patients at Harris Health System in Houston, Texas, might be eligible to participate.

As an unphased trial, this study offers a unique opportunity to contribute to research that could make cervical cancer screening more accessible for everyone.

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 prior data suggests that the Mailed HPV Self-Sampling Kit is safe for cervical cancer screening?

Research shows that mailed HPV self-sampling kits are safe to use. Studies have found that people generally tolerate these kits well, with no serious side effects reported. Most users find the self-sampling process easy and comfortable. Designed for home use, these kits offer convenience for those unable to visit a clinic regularly for screening. Overall, mailed HPV self-sampling kits provide a safe and effective way to increase cervical cancer screening for those who might otherwise skip it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mailed HPV Self-Sampling Kits because they offer a unique and convenient way for cervical cancer screening. Unlike traditional methods that require a visit to a healthcare facility for a Pap smear, this approach allows women to collect samples at home, reducing barriers such as time, travel, and discomfort. By including a patient navigator who provides education and support via phone, the process becomes even more accessible and empowering for participants, potentially increasing screening rates and early detection of cervical cancer.

What evidence suggests that mailed HPV self-sampling kits could be effective for increasing cervical cancer screening participation?

Research has shown that mailing HPV self-sampling kits can increase cervical cancer screening rates among women. In this trial, participants may receive a Mailed HPV Self-Sampling Kit, with or without additional patient navigation support. Studies have found these kits to be affordable and effective in reaching women who might not attend regular screenings. For instance, one study discovered that these kits encouraged more women who hadn't been screened recently to participate. Most women who used the kits reported a positive experience, finding them convenient and easy to use. This approach has proven cost-effective while maintaining effectiveness, making it a promising method to expand cervical cancer screening. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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

I have visited a Harris Health System clinic at least twice in the last 5 years.

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 can communicate in English, Vietnamese, or Spanish.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839517

Cost-Effectiveness of HPV Self-Testing Options for Cervical ... This economic evaluation examines the cost-effectiveness of mailed human papillomavirus (HPV) self-sampling kits among members of a US ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10034577/

Economic Evaluation of Mailed Home-Based Human ... Mailing human papillomavirus self-sampling kits to individuals who are overdue for cervical cancer screening is cost-effective and may be an efficient outreach ...

3. thelancet.com thelancet.com/journals/lanpub/article/PIIS2468-2667(23)00076-2/fulltext

Effect of HPV self-collection kits on cervical cancer ... Mailed HPV self-collection testing has potential to increase uptake of cervical cancer screening among under-screened women. Mailed at-home HPV ...

4. cidrap.umn.edu cidrap.umn.edu/human-papillomavirus-hpv/study-mailing-hpv-tests-women-effective-cost-saving-regardless-cervical

Study: Mailing HPV tests to women effective, cost-saving ... Direct mailing human papillomavirus (HPV) self-testing kits to women's homes was cost-effective for those who regularly undergo cervical cancer ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0749379723004415

Self-Sampling for Human Papillomavirus Testing Among participants who reported using the mailed kit (n=164), most reported good experiences (84.8%). Most reported self-sampling as more/equally convenient ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7580009/

Mailed self-sample HPV testing kits to improve cervical cancer ... The aim is to assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among patients in a safety net ...

7. 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 ...

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04790-5

Mailed self-sample HPV testing kits to improve cervical ... - Trials The current manuscript describes the rationale and design of a hybrid type 2 trial of self-sample HPV testing in a safety net health system.