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

NCT07214506 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY000070585P30CA023074-43
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Cervical Neoplasms; HPV Testing; Pap Smear

Keywords

Cervical cancer screening; HPV self-collection; HPV test; Mobile health unit; Unhoused individuals; Community outreach

Outcome Measures

Primary Outcomes (1)

• Cervical Cancer Screening Completion

  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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

• Follow-up adherence

  From identification of abnormal results to 6 months

Study Arms (2)

Human papillomavirus self-collection for Cervical Cancer Screening

EXPERIMENTAL

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.

Other: Human papillomavirus Self-collection

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

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.

Also known as: HPV self-sampling

Human papillomavirus self-collection for Cervical Cancer Screening

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

Also known as: Pap smear, HPV/PAP Co-test, Provider Sampling

Usual Care

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator
• El Rio Santa Cruz Neighborhood Health Center: collaborator

Study Sites (1)

El Rio Santa Cruz Neighborhood Health

Tucson, Arizona, 85713, United States

Location

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MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Papanicolaou Test

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dan Theodorescu, MD, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Purnima Madhivanan, MBBS, MPH, PhD

  University of Arizona

  STUDY CHAIR

Central Study Contacts

Purnima Madhivanan, MBBS, MPH, PhD

CONTACT

520-621-5730; pmadhivanan@arizona.edu

Rogelio Robles, MD

CONTACT

520 245 5844; rroblesmd@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed trial will randomize eight of the street medicine team's outreach sites 1:1 to either the intervention (invitation to Human Papillomavirus self-collection for cervical cancer screening in the mobile health unit plus usual care from the street medicine team) or usual care alone

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months after publication, with no end date
• Access Criteria: Any researcher seeking access to HOPE data who submits a written request describing the purpose, planned analyses, and data security measures

Locations

US (1)