Clinical trial · Interventional
Human Papillomavirus (HPV) Self-Sampling Options to Promote Equity
Human Papillomavirus Self-Sampling Options to Promote Equity (HOPE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Testing | — | UNRESOLVED | — |
| Pap Smear | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human papillomavirus Self-collection | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Human papillomavirus self-collection for Cervical Cancer Screening
- description
- 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.
- interventionNames
- Other: Human papillomavirus Self-collection
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- 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
- interventionNames
- Other: Usual Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (22)
- BACKGROUNDBrown AW, Li P, Bohan Brown MM, Kaiser KA, Keith SW, Oakes JM, Allison DB. Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials. Am J Clin Nutr. 2015 Aug;102(2):241-8. doi: 10.3945/ajcn.114.105072. Epub 2015 May 27. PMID 26016864
- BACKGROUNDLi P, Redden DT. Small sample performance of bias-corrected sandwich estimators for cluster-randomized trials with binary outcomes. Stat Med. 2015 Jan 30;34(2):281-96. doi: 10.1002/sim.6344. Epub 2014 Oct 24. PMID 25345738
- BACKGROUNDHeintzman J, Hatch B, Coronado G, Ezekiel D, Cowburn S, Escamilla-Sanchez O, Marino M. Role of Race/Ethnicity, Language, and Insurance in Use of Cervical Cancer Prevention Services Among Low-Income Hispanic Women, 2009-2013. Prev Chronic Dis. 2018 Feb 22;15:E25. doi: 10.5888/pcd15.170267. PMID 29470167
- BACKGROUNDUS Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 21;320(7):674-686. doi: 10.1001/jama.2018.10897. PMID 30140884
- BACKGROUNDMichie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42. PMID 21513547
- BACKGROUNDSabatino 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
- BACKGROUNDChristian 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.