Human Papillomavirus (HPV) Self-Sampling Options to Promote Equity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-64
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women or transgender men with a cervix
Ages 30-64 years
No Pap test in the past 3 years, or
No human papillomavirus (HPV) test in the past 5 years
Disqualifiers
History of cervical cancer
HIV positive
History of total hysterectomy
Known pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Human papillomavirus Self-collection
Other interventionThe 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 interventionUsual 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
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Human papillomavirus self-collection for Cervical Cancer ScreeningExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Follow-up adherence
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
Time frame
From identification of abnormal results to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
National Cancer Institute (NCI)
Collaborator
El Rio Santa Cruz Neighborhood Health Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: