HPV DNA Testing Through Mobile Mammography Unit

Study Overview
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Brief Summary
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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. 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. Innovative delivery models are needed to reach at-risk populations. This study seeks to explore the acceptability and feasibility of pairing self-collection of HPV samples for DNA testing with mobile mammography in women living in rural Virginia.

Detailed Description
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The proposed study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in rural Virginia. The procedures will be recruitment of under-screened women in rural Virginia to complete HPV testing using self-collection kits distributed through the mobile mammography unit. 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.

Official Title
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Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by the Mobile

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: HPV self collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: not pregnant Exclusion Criteria: history of hysterectomy or pelvic RT non English speaking

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HPV self collection<br>Pairing self-collection of HPV samples for DNA testing with women seeking mobile mammography. | Device: HPV self collection<br>* The proposed community based participatory study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in Southwest Virginia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cultural Acceptability of Self-Collection for HPV among women seeking a mammogram at a mobile mammogram unit | Assess the cultural acceptability of self-collection for HPV testing among under-screened women in Southwest Virginia who were seeking a mammogram at an episodic clinic. Variables therefore include: uptake of HPV self collection (yes/no); and intention to follow up upon learning of result. | 4 Years | 
| Feasibility of Self-Collection for HPV among women seeking a mobile mammogram | Assess the feasibility of self-collection for HPV testing among under-screened women in Southwest Virginia who were seeking a mammogram at an episodic clinic. Variables therefore include: uptake of HPV self collection (yes/no); and intention to follow up upon learning of result. | 4 Years |