Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators (HPVhometest)
Primary Purpose
Human Papilloma Virus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Viba collection brush
Sponsored by
About this trial
This is an interventional screening trial for Human Papilloma Virus
Eligibility Criteria
Inclusion Criteria:
- 30-65 years old
- Female
- Live in southwest VA
- Not pregnant-self reported
Exclusion Criteria:
- History of Papanicolaou test in the last 3 years
- History of hysterectomy or pelvic radiation
- Co-testing (pap test and HPV test at the same time) in the last 5 years
- English speaking
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HPV home testing kit
Arm Description
The procedures will be recruitment of under-screened women in Health Districts 1, 2 and 3 of Southwest Virginia to complete HPV home testing using self-collection kits distributed by lay navigators. Regardless of HPV positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.
Outcomes
Primary Outcome Measures
Acceptability of at-home self-collection for HPV testing among under-screened women in Southwest Virginia.
Number of participants completing home testing kit, and result of survey evaluating participant acceptability.
Secondary Outcome Measures
Feasibility of utilizing lay navigators to offer at-home HPV self-collection as a strategy to increase cervical cancer screening among under-screened women in Southwest Virginia.
Measured by enrollment and through participant survey results.
Full Information
NCT ID
NCT03139669
First Posted
January 27, 2016
Last Updated
September 13, 2022
Sponsor
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT03139669
Brief Title
Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Acronym
HPVhometest
Official Title
Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Invasive cervical cancer incidence and mortality can be dramatically reduced through early detection and treatment, but many women do not complete screening at recommended intervals. Many low-income women in Virginia remain uninsured and are at significant risk of being medically underserved and failing to complete regular cervical cancer screening. At-home self-collection of specimens for HPV testing is an innovative approach that may increase access to cervical cancer screening in populations that do not participate in traditional clinic-based screening. The proposed community based participatory study aims to determine whether offering at-home self-collection for HPV testing through a lay navigator network is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in the Tobacco Footprint in rural far Southwest Virginia (Health Districts 1, 2 and 3). The procedures will be recruitment of under-screened women in Health Districts 1, 2 and 3 of Southwest Virginia to complete HPV testing using self-collection kits distributed by lay navigators. Regardless of HPV positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.
Detailed Description
The catchment area for the University of Virginia Health System and Emily Couric Clinical Cancer Center (EC4) extends throughout Southwest Virginia and into neighboring West Virginia, encompassing a portion of Appalachia. State-wide incidence of cervical cancer was 6.6 cases per 100,000 from 2005-2009, but variation exists county by county: Cumberland (Health District 2), Roanoke, and Southside were among those with the highest incidence. The significant decrease in cervical cancer incidence and mortality rates in the US and in Virginia since 1950 is directly attributed to increased early detection and screening. The Virginia Department of Health's Comprehensive Cancer Control Program found that patient level barriers to screening for women in this region include lower education, lower income, and lack of health insurance. Systems-level barriers in this region include decreased access to screening services, financial barriers, and transportation barriers. This study will assess a novel approach to addressing patient level and systems-level barriers to accessing cervical cancer screening in Virginia Health Districts 1, 2 and 3, and utilizes an innovative technology (self-collection for HPV testing) and delivery model (distributed by lay navigators).
Self-collection for HPV testing paired with a community health worker program is a model that has been found to have great utility in accessing at risk women in Little Haiti, South Florida, as well as in rural Haiti. Community health workers often have training in a variety of health issues and conditions. Patient navigators trained in cervical cancer screening and treatment specifically have been utilized to understand patient barriers to in-clinic screening. The lay navigator program the investigators will work with in Health Districts 1, 2 and 3 involves cancer-specific training (including but not limited to cervical cancer training), and training on facilitating access to screening and treatment resources available in Health Districts 1, 2 and 3, as well as at the University of Virginia Health System. Lay navigators are therefore uniquely poised to provide education to women around the use of HPV self-collection, and to navigate women to in-clinic Pap screening, treatment, and support services as needed.
Reach of Current Lay Navigators Trained using the "Understanding Cancer" curriculum (developed by partners listed above), lay navigators in Russell County (Cumberland Health District) reported 312 encounters between 2/10/14 and 12/17/14 classified as "preventative" specific to breast cancer. Between 1/23/14 and 9/24/14, navigators across Lenowisco Health District provided 233 cancer-related encounters, including navigation services for 4 women diagnosed with cervical cancer. The lay navigator program has the potential to be a rich resources for community based research in Southwest Virginia.
Protocol Development Dr. Mitchell is currently a Co-I on the NCI-funded project P30CA044579 (PI: Thomas Loughran, MD, 2014-2015). Through this work, the investigators are developing a list of key stakeholders, which will be consulted in Phases I and II of this study. Additionally, the community advisory board (CAB) of the Cancer Center Without Walls initiative will be consulted throughout protocol development.
Dr. Mitchell has developed a collaboration with Dr. Jennifer S. Smith, Associate Professor of Epidemiology at the University of North Carolina at Chapel Hill. Dr. Smith and her research team have extensive experience and expertise with HPV screening and prevention, specifically exploring delivery models for HPV self-collection in medically underserved areas of North Carolina. The investigators are planning to collaborate on this pilot study, and based on these findings, to develop a proposal for an NIH/NCI R01 grant as co-PIs. Dr. Smith and the research team have conducted two previous studies assessing the acceptability, feasibility, and validity of HPV self-collection. Through these studies, the investigators have identified brush designs that are minimally invasive, well-accepted, and effective for self-collection and sample preservation media that is non-toxic, safe for mailing, and stable at a range of temperatures; and have developed well-validated, field-tested illustrated instructions for self-collection that are comprehensible to low-literacy women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV home testing kit
Arm Type
Experimental
Arm Description
The procedures will be recruitment of under-screened women in Health Districts 1, 2 and 3 of Southwest Virginia to complete HPV home testing using self-collection kits distributed by lay navigators. Regardless of HPV positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.
Intervention Type
Device
Intervention Name(s)
Viba collection brush
Intervention Description
HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.
Primary Outcome Measure Information:
Title
Acceptability of at-home self-collection for HPV testing among under-screened women in Southwest Virginia.
Description
Number of participants completing home testing kit, and result of survey evaluating participant acceptability.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Feasibility of utilizing lay navigators to offer at-home HPV self-collection as a strategy to increase cervical cancer screening among under-screened women in Southwest Virginia.
Description
Measured by enrollment and through participant survey results.
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
30-65 years old
Female
Live in southwest VA
Not pregnant-self reported
Exclusion Criteria:
History of Papanicolaou test in the last 3 years
History of hysterectomy or pelvic radiation
Co-testing (pap test and HPV test at the same time) in the last 5 years
English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Mitchell, PhD
Organizational Affiliation
Faculty
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17970859
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
24433684
Citation
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Results Reference
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PubMed Identifier
23618210
Citation
Racey CS, Withrow DR, Gesink D. Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. Can J Public Health. 2013 Feb 11;104(2):e159-66. doi: 10.1007/BF03405681.
Results Reference
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PubMed Identifier
21384341
Citation
Gravitt PE, Belinson JL, Salmeron J, Shah KV. Looking ahead: a case for human papillomavirus testing of self-sampled vaginal specimens as a cervical cancer screening strategy. Int J Cancer. 2011 Aug 1;129(3):517-27. doi: 10.1002/ijc.25974.
Results Reference
background
PubMed Identifier
20592553
Citation
Balasubramanian A, Kulasingam SL, Baer A, Hughes JP, Myers ER, Mao C, Kiviat NB, Koutsky LA. Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples. J Low Genit Tract Dis. 2010 Jul;14(3):185-95. doi: 10.1097/LGT.0b013e3181cd6d36.
Results Reference
background
PubMed Identifier
22619675
Citation
Kobetz E, Kish JK, Campos NG, Koru-Sengul T, Bishop I, Lipshultz H, Barton B, Barbee L. Burden of Human Papillomavirus among Haitian Immigrants in Miami, Florida: Community-Based Participatory Research in Action. J Oncol. 2012;2012:728397. doi: 10.1155/2012/728397. Epub 2012 Mar 15.
Results Reference
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PubMed Identifier
25468050
Citation
Mandigo M, Frett B, Laurent JR, Bishop I, Raymondville M, Marsh S, Kobetz E. Pairing community health workers with HPV self-sampling for cervical cancer prevention in rural Haiti. Int J Gynaecol Obstet. 2015 Mar;128(3):206-10. doi: 10.1016/j.ijgo.2014.09.016. Epub 2014 Nov 11.
Results Reference
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Citation
Ely GE, White C, Jones K, Feltner F, Gomez M, Shelton B, Slone S, Van Meter E, Desimone C, Schoenberg N, Dignan M. Cervical cancer screening: exploring Appalachian patients' barriers to follow-up care. Soc Work Health Care. 2014;53(2):83-95. doi: 10.1080/00981389.2013.827149.
Results Reference
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Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
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