An interventional study of Viba collection brush in Human Papilloma Virus, sponsored by University of Virginia. Completed. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by University of Virginia · Not applicable, Interventional, and Screening
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.
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 several rural and remote areas around the world. 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 Virginia 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 was a Co-I on the NCI-funded project P30CA044579 (PI: Thomas Loughran, MD, 2014-2015). Through this work, the investigators developed 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 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. Dr. Smith and the research team have conducted multiple 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.
234 studies on the registry are indexed under Papilloma; 28 are open to participants now.
This study's enrollment of 45 is below the median of 100 across 159 interventional studies indexed under Papilloma.
Browse Papilloma studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
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.
Device: Viba collection brush
HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.
Acceptability of At-home Self-collection for HPV Testing Among Under-screened Women in Southwest Virginia.
ACCEPTABILITY was measured through: uptake of self-collection kit (yes/n).
Time frame: 1 month
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.
FEASIBILITY was measured by: uptake of self-collection kits (y/n), and whether that sample was sufficient for processing a result. If acceptability (uptake) was high but sufficiency of sample collection was low, there would be decreased feasibility of this approach.
Time frame: 1 month
| Milestone | HPV Home Testing Kit |
|---|---|
| Started | 45 |
| Completed | 45 |
| Not completed | 0 |
ACCEPTABILITY was measured through: uptake of self-collection kit (yes/n).
| Participants | HPV Home Testing Kit |
|---|---|
| Acceptability of At-home Self-collection for HPV Testing Among Under-screened Women in Southwest Virginia. | 45 |
FEASIBILITY was measured by: uptake of self-collection kits (y/n), and whether that sample was sufficient for processing a result. If acceptability (uptake) was high but sufficiency of sample collection was low, there would be decreased feasibility of this approach.
| Participants | HPV Home Testing Kit |
|---|---|
| HPV self-collection kit uptake, sufficient sample to process a result | 42 |
| HPV self-collection kit uptake, insufficient sample collected to process a result | 3 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HPV Home Testing Kit | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Age, Categorical(Participants) | HPV Home Testing Kit |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 45 |
| >=65 years | 0 |
| Age, Continuous(years) | HPV Home Testing Kit |
|---|---|
| Median | 44.8 (31 to 62) |
| Sex: Female, Male(Participants) | HPV Home Testing Kit |
|---|---|
| Female | 45 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | HPV Home Testing Kit |
|---|
| Smoking Status (Current Smoker)(Participants) | HPV Home Testing Kit |
|---|---|
| Current Smoker | 28 |
| Non-Smoker | 17 |
| Seen healthcare provider in last year (yes/no)(Participants) | HPV Home Testing Kit |
|---|---|
| Have seen a healthcare provider in the last year | 30 |
| Have not seen a healthcare provider in the last year | 11 |
| Missing | 4 |
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Plan to share: No
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