HPV
Conditions
Keywords
HPV, Self-Sampling, Colposcopy, Cervical cancer, Cancer screening
Brief summary
This study seeks to compare the accuracy and acceptability of HPV testing self-sampling kit and standard clinician-sampling for HPV testing. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test, Pap smear results, and colposcopy. 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.
Detailed description
The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical cancer in 2018 (Siegel et al., 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 (Shieh et al., 2016). Guidelines recommend cytology and/or HPV testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal (U.S. Preventive Services Task Force, 2018; Saslow et al., 2012). To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical-sampling for HPV testing. However, there are concerns about the comparability and acceptability of self-sampling kits. The main objective of this study is to compare the test characteristics of the human papillomavirus (HPV) self-sampling kit versus clinician-sampled HPV testing for cervical cancer screening. Potential participants will be identified from the Penn State Family and Community Medicine and OBGYN clinics after it is determined that they have abnormal findings on their (clinician-sampled) Pap/HPV test and require a follow-up colposcopy. The patient will be pre-screened by a study team member. If they are found to be eligible, a study team member will invite them to participate in the study. After a participant enrolls in the study, a self-sampling kit is mailed to their home along with a Summary Explanation of Research consent form and instructional sheet. Participants will be asked to complete the kit two weeks before or after their colposcopy, giving them a 28 day collection window. Study team members will perform a follow-up survey after the sample is collected and provide reminder phone calls if needed.
Interventions
DEVICEEvalyn Brush
The Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Participants who enroll in the study will be asked to complete an HPV self-sampling kit in addition to completing their colposcopy exam. Participants will collect the sample at home before or after their exam and mail it back to the Penn State Health laboratory for analysis. The results will be compared to those of the clinician-collected (standard of care) colposcopy exam, Pap, and HPV test. Participants will also complete a follow up survey over the phone after their sample is collected.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Penn State Health Patient * Has an intact cervix * Found to have abnormal findings on Pap/HPV test that requires a colposcopy * Speaks, read, or writes well in English or Spanish
Exclusion criteria
* Pregnant * Cognitively impaired * Incarcerated * Complete hysterectomy * History of cervical treatment for abnormal Pap/HPV test (i.e. cryotherapy, loop electrosurgical excision procedure (LEEP))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Concordance of Screening Results of the Self-Sampling Kit Compared to Clinician-collected Samples | Within two weeks of their colposcopy exam. | The primary outcome of this study is to analyze the number of participants with concordance of screening results of the self-sampling kit compared to clinician-collected HPV test, Pap smear results, and colposcopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Completed Self-Sampling Kits | Within two weeks of their colposcopy exam. | The number of participants provided a kit vs. those who completed the sample collection |
| Number of Participants Who Reported Problems Using Self-Sampling Kits | Within two weeks of their colposcopy exam | The number of participants, among those who completed the sample collection, who reported problems using the self-sampling kit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants The participants in this study were scheduled for a colposcopy procedure due to abnormal findings during their recent standard-of-care, clinical-collected cervical cancer screening. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| annual household income <$50,000 | 2 Participants |
| annual household income $50,000 + | 9 Participants |
| annual household income unknown/not reported | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Number of Participants With Concordance of Screening Results of the Self-Sampling Kit Compared to Clinician-collected Samples
The primary outcome of this study is to analyze the number of participants with concordance of screening results of the self-sampling kit compared to clinician-collected HPV test, Pap smear results, and colposcopy.
Time frame: Within two weeks of their colposcopy exam.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants | Number of Participants With Concordance of Screening Results of the Self-Sampling Kit Compared to Clinician-collected Samples | 8 Participants |
Secondary
Number of Completed Self-Sampling Kits
The number of participants provided a kit vs. those who completed the sample collection
Time frame: Within two weeks of their colposcopy exam.
Population: Total number of participants who were provided with a self-sampling kit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants | Number of Completed Self-Sampling Kits | 12 Participants |
Secondary
Number of Participants Who Reported Problems Using Self-Sampling Kits
The number of participants, among those who completed the sample collection, who reported problems using the self-sampling kit.
Time frame: Within two weeks of their colposcopy exam
Population: Total number of participants who returned the self-sampling kit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants | Number of Participants Who Reported Problems Using Self-Sampling Kits | 0 Participants |