Self-Sampling for Human Papillomavirus (HPV) at Well Women Appointments

Not Applicable

Terminated

Conditions: HPV

Interventions: Device: HPV Self-Sampling Kit (Evalyn Brush)

Registration Number: NCT04591977

Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary: This study seeks to compare the accuracy and acceptability of Human Papillomavirus (HPV) testing self-sampling kit versus standard clinician-sampled HPV testing for cervical cancer screening. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test and Pap smear results. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative to clinician sampling.

Detailed Description: The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical cancer in 2018. Screening can reduce cancer mortality by (1) detecting malignancies when they are more treatable and (2) for some tests, identifying precancerous lesions for removal. Guidelines recommend cytology and/or human papillomavirus (HPV) testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal.

To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical screening. However, there are concerns about the comparability and acceptability of self-sampling kits. The impact of the proposed project is to compare HPV self-screening results with Pap smear results and clinician-collected HPV tests to ultimately improve the uptake of HPV screening. This study will be conducted in a normal risk population.

Subjects who have an upcoming well-woman appointment will be identified from Penn State Health, Department of Family and Community Medicine, clinic schedules. Clinicians who are a part of the study team will identify these patients two weeks prior to their appointment and send their information to a study coordinator, who will then call these patients to provide more information and assess their interest in participating. Patients who schedule within the two week period or were not contacted by a study team member for any reason will be given a card with general information about the study at their well-woman visit so that these women can contact a study team member if they are interested. A total of 197 participants will be recruited into this study.

Interested participants will be screened for eligibility over the phone and sent a self-sampling kit through the mail with a Summary Explanation of Research form, instructions, and pre-paid mailer to return the kit. Participants may collect their sample two weeks before or after their well-woman visit. A study team member will contact the participants at different time points within the 28 day window to determine whether the sample was collected and to administer the follow-up survey.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 46

Inclusion Criteria

Age 30-65 Years
Penn State Health, Family and Community Medicine, patient attending a well-woman visit
Able to collect the sample within two weeks of visit
Female
Intact cervix
Speaks, reads, or writes in English

Exclusion Criteria

Pregnancy
Cognitively Impaired
Incarcerated
Complete hysterectomy
History of cervical treatment for abnormal Pap/HPV test (cryotherapy, LEEP)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self-Sampling Kit	HPV Self-Sampling Kit (Evalyn Brush)	Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Concordance of Screening Results of the Self-sampling Kit Compared to Clinical-collected Samples	Within two weeks of the well-woman visit	Number of participants whose results of the self-sampling kit were in concordance with the clinician-sampled HPV test and clinician-sampled Pap smear results.

Secondary Outcome Measures

Name	Time	Method
Number of Completed Self-Sampling Kits	28 days (two weeks before or after the well-woman visit)	The number of participants provided a kit vs. those who completed the sample collection
Number of Participants Who Reported Problems With Using Self-Sampling Kits	Within two weeks of the well-woman visit	The number of participants, among those who completed the sample collection, who reported problems using the self-sampling kit.