Trial Outcomes & Findings for Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators (NCT NCT03139669)

NCT ID: NCT03139669

Last Updated: 2024-09-24

Results Overview

ACCEPTABILITY was measured through: uptake of self-collection kit (yes/n).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2024-09-24

Participant Flow

Participant milestones

Measure	HPV Home Testing Kit 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. Viba collection brush: HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.
Overall Study STARTED	45
Overall Study COMPLETED	45
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

Measure	HPV Home Testing Kit n=45 Participants 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. Viba collection brush: HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.
Age, Categorical <=18 years	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=45 Participants
Age, Continuous	44.8 years n=45 Participants
Sex: Female, Male Female	45 Participants n=45 Participants
Sex: Female, Male Male	0 Participants n=45 Participants
Smoking Status (Current Smoker) Current Smoker	28 Participants n=45 Participants
Smoking Status (Current Smoker) Non-Smoker	17 Participants n=45 Participants
Seen healthcare provider in last year (yes/no) Have seen a healthcare provider in the last year	30 Participants n=45 Participants
Seen healthcare provider in last year (yes/no) Have not seen a healthcare provider in the last year	11 Participants n=45 Participants
Seen healthcare provider in last year (yes/no) Missing	4 Participants n=45 Participants

PRIMARY outcome

Timeframe: 1 month

ACCEPTABILITY was measured through: uptake of self-collection kit (yes/n).

Outcome measures

Measure

HPV Home Testing Kit n=45 Participants 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. 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.

45 Participants

SECONDARY outcome

Timeframe: 1 month

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.

Outcome measures

Measure	HPV Home Testing Kit n=45 Participants 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. Viba collection brush: HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.
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. HPV self-collection kit uptake, sufficient sample to process a result	42 Participants
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. HPV self-collection kit uptake, insufficient sample collected to process a result	3 Participants

Adverse Events

HPV Home Testing Kit

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

Dr. Emma Mitchell Associate Professor

University of Virginia

Phone: 4342433962

Email: emm6z@virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place