Cervical Cancer
Conditions
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. 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
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.
Interventions
DEVICEHPV self collection
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.
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* not pregnant
Exclusion criteria
* history of hysterectomy or pelvic RT non English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Self-Collection Paired With Mobile Mammography | 1 month (to allow for time to process samples and communicate results) | Assess the cultural acceptability of self-collection for HPV testing among under-screened women in Southwest Virginia specifically who were seeking a mammogram at an episodic clinic. The outcome measure of ACCEPTABILITY was measured through: participants who opted in, or uptake of HPV self collection (yes/no); and intention to follow up upon learning of result. |
| Feasibility of Self-Collection for HPV Paired With Mobile Mammography | 1 month (to allow for time to process samples and communicate results) | 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. FEASIBILITY was measured through: participant uptake of HPV self collection (yes/no); observations of clinic flow (i.e. how did this additional screening fit in with existing mammography services); and quality of samples collected (were any collected inaccurately or in a way that was impossible to detect). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HPV Self Collection Pairing self-collection of HPV samples for DNA testing with women seeking mobile mammography.
HPV self collection: 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. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | HPV Self Collection | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 33 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 33 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Acceptability of Self-Collection Paired With Mobile Mammography
Assess the cultural acceptability of self-collection for HPV testing among under-screened women in Southwest Virginia specifically who were seeking a mammogram at an episodic clinic. The outcome measure of ACCEPTABILITY was measured through: participants who opted in, or uptake of HPV self collection (yes/no); and intention to follow up upon learning of result.
Time frame: 1 month (to allow for time to process samples and communicate results)
Population: Participants seeking mobile mammography at an episodic clinic in far Southwest Virginia (Planning Districts 1 and 2) were screened for eligibility and recruited for this study. Acceptability was measured by participant's uptake of self-collection (y/n). Of the 33 participants, 100% participated in self-collection of samples for HPV testing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV Self Collection | Acceptability of Self-Collection Paired With Mobile Mammography | 33 Participants |
Primary
Feasibility of Self-Collection for HPV Paired With Mobile Mammography
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. FEASIBILITY was measured through: participant uptake of HPV self collection (yes/no); observations of clinic flow (i.e. how did this additional screening fit in with existing mammography services); and quality of samples collected (were any collected inaccurately or in a way that was impossible to detect).
Time frame: 1 month (to allow for time to process samples and communicate results)
Population: Participants seeking mobile mammography at an episodic clinic in far Southwest Virginia (Planning Districts 1 and 2) were screened for eligibility and recruited for this study. Feasibility was measured by participant's uptake of self-collection (y/n) and quality of samples collected for testing. Of the 33 participants, 100% of samples collected yielded results.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV Self Collection | Feasibility of Self-Collection for HPV Paired With Mobile Mammography | 33 Participants |