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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07214506
Status
Not Yet Recruiting

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Conditions

  • HPV Testing
  • Pap Smear
  • Uterine Cervical Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Human papillomavirus Self-collection — OTHER
    The individual will receive both verbal instruction on self-collection from trained health educators in the mobile health unit, as well as adapted educational materials on human papillomavirus self-collection and information about follow-up care in the case of abnormal results. Individuals will be provided with a safe and private space in the Mobile Health Unit to self-collect.
  • Usual Care — OTHER
    Usual care, will involve reminders about overdue Cervical Cancer screening and support with scheduling clinic appointments for screening, arranging for transportation, and addressing other barriers to attendance

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Human papillomavirus self-collection for Cervical Cancer Screening
    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.
  • Active Comparator: Usual Care
    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

Primary Outcome Measure

Cervical Cancer Screening Completion [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
El Rio Santa Cruz Neighborhood HealthTucsonArizona85713
Lisa Soltani, MD
[email protected]
520 670 3909

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By research site
El Rio Santa Cruz Neighborhood Health· Tucson, AZ

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