Human Papillomavirus (HPV) Self-Sampling Options to Promote Equity (HOPE)

University of Arizona

Status: Not yet enrolling

Conditions: Uterine Cervical Neoplasms; Pap Smear; HPV Testing

Treatments: Other: Usual Care; Other: Human papillomavirus Self-collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07214506

STUDY00007058

5P30CA023074-43 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is testing a new way to help people who are unhoused get screened for cervical cancer. Cervical cancer can often be prevented if it is found early. Many people who lack stable housing usually do not receive regular screenings.

Through this project, the investigators will bring screening to community locations in Tucson, Arizona, using a mobile health unit (MHU) from the University of Arizona (UA) and El Rio Health. At these sites, participants will receive easy-to-understand education about cervical cancer, learn how to collect their own sample for human papillomavirus (HPV) testing, and get follow-up care if needed.

The study has two goals:

• First, the investigators will see if this community-based approach helps more people complete cervical cancer screening.
• Second, the investigators will ask participants, clinicians, and outreach staff for their opinions about the program and its practicality and acceptability.

By testing this approach, the investigators hope to find a way to make cervical cancer screening more accessible and effective for unhoused individuals.

Full description

Cervical cancer can often be prevented if it is found early, but many unhoused people don't get regular screening. Through this project, the investigators are offering cervical cancer screening in community settings, such as our mobile health units, to make access easier.

Our proposal aims to design and pilot test an human papillomavirus (HPV) self-sampling program run through an MHU (operated by the UA) throughout El Rio's established outreach sites to people who are unhoused and residing in shelters and outdoor encampments. The proposed intervention, delivered through a clinic-community linkage, will include tailored education about the importance of cervical cancer screening, information on how to perform HPV self-collection, and follow-up as needed. The investigators propose the following Aims:

Aim 1. In a pragmatic pilot trial, assess the preliminary effectiveness of a community-driven, resource-efficient MHU-delivered program to distribute HPV DNA self-collection test kits to eligible unhoused individuals in Tucson, Arizona.

The primary outcome will be the completion of screening among eligible individuals. Secondary outcomes will be (1) screening modality selected (self-collected HPV, clinician-collected HPV, Pap smear, or co-test) and (2) follow-up of abnormal initial screening results within 6 months after the initial result.

Aim 2. Evaluate the feasibility and acceptability of the MHU-based HPV self-collection program through in-depth interviews with individuals who completed self-collection, clinicians, and outreach staff in the HOPE program.

Interview domains will be informed by the COM-B (capability, opportunities, motivation - behavior) framework, and outcomes will be analyzed using thematic analysis with a combination of inductive and deductive coding.

Enrollment: 100 estimated patients

Sex: Female

Ages: 30 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women or transgender men with a cervix

• Ages 30-64 years

• Due for cervical cancer screening:

  1. No Pap test in the past 3 years, or
  2. No human papillomavirus (HPV) test in the past 5 years

• Unhoused or unstably housed

Exclusion criteria

• History of cervical cancer
• HIV positive
• History of total hysterectomy
• Known pregnancy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Human papillomavirus self-collection for Cervical Cancer Screening

Experimental group

Description:

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.

Treatment:

Other: Human papillomavirus Self-collection

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care