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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Human 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.
• Другое Usual 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

Первичные конечные точки

• Cervical Cancer Screening Completion [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (1)

• Follow-up adherence [Срок оценки: From identification of abnormal results to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• El Rio Santa Cruz Neighborhood Health — Tucson

Публикации

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• Sabatino SA, Thompson TD, White MC, Shapiro JA, Clarke TC, Croswell JM, Richardson LC. Cancer Screening Test Use-U.S., 2019. Am J Prev Med. 2022 Sep;63(3):431-439. doi: 10.1016/j.amepre.2022.02.018. Epub 2022 Apr 22. PMID 35469700
• Christian NJ, Havlik J, Tsai J. The Use of Mobile Medical Units for Populations Experiencing Homelessness in the United States: A Scoping Review. J Gen Intern Med. 2024 Jun;39(8):1474-1487. doi: 10.1007/s11606-024-08731-9. Epub 2024 Mar 25. PMID 38528232
• Degife EA, Oliveira CR, Znamierowski E, Meyer JP, Sheth SS. Uptake of Cervical Cancer Screening Among Female Patients Using a Mobile Medical Clinic. Am J Prev Med. 2023 Nov;65(5):835-843. doi: 10.1016/j.amepre.2023.05.013. Epub 2023 May 21. PMID 37220860

Идентификаторы

NCT: NCT07214506 · STUDY00007058 · 5P30CA023074-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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