Trial Outcomes & Findings for HPV DNA Testing Through Mobile Mammography Unit (NCT NCT03551028)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

1 month (to allow for time to process samples and communicate results)

Results posted on

2024-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HPV Self Collection n=33 Participants 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.
Age, Categorical <=18 years	0 Participants n=33 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=33 Participants
Age, Categorical >=65 years	0 Participants n=33 Participants
Sex: Female, Male Female	33 Participants n=33 Participants
Sex: Female, Male Male	0 Participants n=33 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	HPV Self Collection n=33 Participants 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.
Acceptability of Self-Collection Paired With Mobile Mammography	33 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	HPV Self Collection n=33 Participants 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.
Feasibility of Self-Collection for HPV Paired With Mobile Mammography	33 Participants

Adverse Events

HPV Self Collection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emma Mitchell

University of Virginia

Phone: 4342433962

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place