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NCT Number: NCT07214506

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

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.

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Key information

Conditions

Uterine Cervical Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV Testing Neoplasms Neoplasms by Site Pap Smear Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms

Age range

30 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

El Rio Santa Cruz Neighborhood Health

Tucson, Arizona, 85713, United States

Location contact

Lisa Soltani, MD

CONTACT

[email protected]

520 670 3909

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women or transgender men with a cervix
  • Ages 30-64 years
  • Due for cervical cancer screening:
  • No Pap test in the past 3 years, or
  • 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

Treatment and study plan

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.

Other names: HPV self-sampling

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

Other names: Pap smear, HPV/PAP Co-test, Provider Sampling

Primary outcomes

  1. Cervical Cancer Screening Completion

    Time frame: From enrollment to the end of treatment at 8 weeks

    Cervical cancer screening completion will be defined as the completion of any form of cervical cancer screening permitted according to the U.S. Preventive Services Task Force (USPSTF) guidelines, including Pap tests, Pap tests with high-risk human papillomavirus tests (cotesting), or high-risk human papillomavirus testing alone. The primary outcome will be assessed within 2 months of the street medicine team's patient contact during the trial period to account for the time required for scheduling a clinic appointment.

Secondary outcomes

  1. Follow-up adherence

    Time frame: From identification of abnormal results to 6 months

    The secondary outcome will be follow-up adherence for abnormal screening results ascertained via electronic health record review within six months of the abnormal result

Study contacts

Contact information is provided by the study sponsor or research team.

Purnima Madhivanan, MBBS, MPH, PhD

CONTACT

[email protected]

520-621-5730

Rogelio Robles, MD

CONTACT

[email protected]

520 245 5844

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • El Rio Santa Cruz Neighborhood Health Center
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: HOPE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 9, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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