HPV Self-Sampling Options to Promote Equity

Not Applicable

Not yet recruiting

• Conditions: Uterine Cervical Neoplasms; HPV Testing; Pap Smear

• Registration Number: NCT07214506
• Lead Sponsor: University of Arizona

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, we will bring screening to community locations in Tucson, Arizona, using a mobile health unit (MHU) from the University of Arizona 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, we will see if this community-based approach helps more people complete cervical cancer screening.

* Second, we will ask participants, clinicians, and outreach staff what they think about the program and whether it is practical and acceptable.

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

Detailed Description

Cervical cancer can often be prevented if it is found early, but many unhoused people don't get regular screening. Through this project, we 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 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 CxCa screening, information on how to perform HPV self-collection, and follow-up as needed. We 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, 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-10-07
• Study First Submitted QC: 2025-10-07
• Last Update Submitted: 2025-10-07
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2026-01-01
• Primary Completion: 2026-10-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women or transgender men with a cervix, aged 30-64 years, due for cervical cancer screening (who have not had a Pap test in the last three years or an HPV test in the previous five years), who are unhoused or unstably housed

Exclusion Criteria

• History of Cervical Cancer, HIV positive, History of total hysterectomy, Known pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cervical Cancer Screening Completion	From enrollment to the end of treatment at 8 weeks	CxCa screening completion will be defined as completion of any form of CxCa screening permitted according to USPSTF guidelines: Pap test, Pap test with high-risk HPV test (cotesting), or high-risk HPV 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 Outcome Measures

Name	Time	Method
Follow-up adherence	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

Trial Locations

Locations (1)

El Rio Santa Cruz Neighborhood Health; 🇺🇸 Tucson, Arizona, United States