HPV Self-collection for Cervical Cancer

(HOPE Trial)

Overseen By Rogelio Robles, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Cervical cancer, HIV, Hysterectomy, Pregnancy

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

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 for people who are unhoused in Tucson, Arizona. Researchers are testing whether allowing participants to collect their own samples for HPV testing (a virus that can cause cervical cancer) can increase screening rates. The trial will compare this new approach, called HPV Self-collection, with usual care to determine which is more effective. Women or transgender men with a cervix who haven't had a Pap or HPV test in the last few years and are unstably housed might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve healthcare access for vulnerable populations.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that HPV self-collection is safe for cervical cancer screening?

Research has shown that collecting one's own sample for HPV (human papillomavirus) testing is a safe method for cervical cancer screening. Studies have found these self-collected samples effective for primary HPV screening, working well for individuals without symptoms and at average risk.

Additionally, past research indicates that women who haven't been regularly screened consider HPV self-collection a good option. This method is gaining popularity as it makes cervical cancer screening easier and more accessible.

Overall, evidence suggests that self-collection is a safe and well-accepted choice for HPV testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HPV self-collection for cervical cancer screening because it offers a more accessible and private way to test for the virus compared to traditional methods like Pap smears. This method allows individuals to collect samples themselves using a simple kit, which can be especially beneficial for those who face barriers to accessing regular healthcare services. By making it easier for people to test themselves, HPV self-collection could increase screening rates and early detection, potentially reducing cervical cancer cases and deaths.

What evidence suggests that HPV self-collection is effective for cervical cancer screening?

Research shows that allowing individuals to collect their own samples for HPV testing can increase cervical cancer screening rates. In this trial, one group will use HPV self-collection in a mobile health unit, while another will receive usual care. Studies have found this self-collection method both affordable and effective, particularly for those who don't regularly visit a doctor. By enabling individuals to collect their own samples, more people who are typically not screened can be reached. Evidence from various regions, both wealthy and less wealthy, supports that self-sampling for HPV is a promising way to increase screening. Overall, this method helps reach more people and can catch cervical cancer early, making it easier to treat. ^{6 7 8 9 10}

Who Is on the Research Team?

Dan Theodorescu, MD, PhD

Principal Investigator

University of Arizona

Purnima Madhivanan, MBBS, MPH, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for individuals who are unhoused and may not have regular access to cervical cancer screenings. Participants will be educated on cervical cancer, learn self-collection for HPV testing, and receive follow-up care as needed in Tucson, Arizona.

Inclusion Criteria

I am a woman or transgender man aged 30-64, due for cervical screening, and without stable housing.

Exclusion Criteria

HIV positive

Known pregnancy

I have a history of cervical cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive education about cervical cancer and learn how to self-collect samples for HPV testing using a mobile health unit

8 weeks

Visits at community locations using a mobile health unit

Follow-up

Participants are monitored for follow-up adherence for abnormal screening results

6 months

What Are the Treatments Tested in This Trial?

Interventions

• HPV Self-collection

Trial Overview The study is examining a new community-based approach using a mobile health unit to increase cervical cancer screening among the unhoused population. It involves education about cervical cancer and self-collected HPV testing.

How Is the Trial Designed?

Group I: Human papillomavirus self-collection for Cervical Cancer Screening Experimental Treatment 1 Intervention

The eight outreach sites will be randomized 1:1 to arm 1 (invitation to human papillomavirus self-collection in the mobile health unit) or arm 2 (usual care), stratifying on type of outreach site to ensure balance between shelter and encampment sites in both arms.

Group II: Usual Care Active Control 1 Intervention

The eight outreach sites will be randomized 1:1 to arm 1 (invitation to HPV self-collection in the MHU) or arm 2 (usual care), stratifying on type of outreach site to ensure balance between shelter and encampment sites in both arms

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

El Rio Santa Cruz Neighborhood Health Center

Collaborator

Trials

1

Recruited

1,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524653/

Cost-effectiveness of human papillomavirus (HPV) self ... Our findings show that employing HPV self-collection was both affordable and effective in increasing cervical cancer screening uptake among underscreened, ...

2. 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 ...

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

Effect of HPV self-collection kits on cervical cancer ... At-home HPV self-collection testing has the potential to increase screening uptake among under-screened women. Funding. National Cancer ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524001207

Performance of a vaginal self-collection device versus ... This study aims to validate the performance of the vaginal self-sampling device (Vitroveil®) to detect high risk human papillomavirus (hrHPV) in comparison to ...

5. gocm.bmj.com gocm.bmj.com/content/4/3/e000059

the promise and future of self-sampling HPV testing Evidence from both high-income and low-income areas suggests that self-sampling HPV testing can effectively increase cervical cancer screening ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144659/

Self-Collection for Cervical Cancer Screening in a Safety- ... This randomized clinical trial compares the effectiveness of mailed self-collection kits, with and without patient navigation, to telephone reminders to ...

7. dceg.cancer.gov dceg.cancer.gov/news-events/news/2025/self-collection-hpv-testing

New Guidelines for HPV Testing Using Self Collection - NCI Self-collected vaginal specimens are acceptable for primary HPV screening of asymptomatic average risk individuals. For patients with prior ...

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

Self-Sampling for Human Papillomavirus Testing Self-sampling for human papillomavirus testing is increasingly recognized as a strategy to expand cervical cancer screening access and utilization.

9. annemergmed.com annemergmed.com/article/S0196-0644(24)01117-X/fulltext

Self-Collection for Primary HPV Testing: Acceptability in a ... In summary, our data suggest that HPV self-collection was well accepted by underscreened women waiting to receive noncritical care at the safety ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11939108/

Self-Collected Vaginal Specimens for HPV Testing Clinician-collected cervical specimens are preferred and self-collected vaginal specimens are acceptable for primary HPV screening of asymptomatic average-risk ...