HPV Testing, Pap Smear, Uterine Cervical Neoplasms
Conditions
Keywords
Cervical cancer screening, HPV self-collection, HPV test, Mobile health unit, Unhoused individuals, Community outreach
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.
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, 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.
Interventions
OTHERHuman papillomavirus Self-collection
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.
OTHERUsual Care
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
Sponsors
University of Arizona
National Cancer Institute (NCI)
El Rio Santa Cruz Neighborhood Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Women or transgender men with a cervix * Ages 30-64 years * Due for cervical cancer screening: 1. No Pap test in the past 3 years, or 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Cancer Screening Completion | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTPurnima Madhivanan, MBBS, MPH, PhD
CONTACTRogelio Robles, MD
PRINCIPAL_INVESTIGATORDan Theodorescu, MD, PhD
University of Arizona
STUDY_CHAIRPurnima Madhivanan, MBBS, MPH, PhD
University of Arizona
Outcome results
None listed