Trial Outcomes & Findings for Self-sampling for Human Papillomavirus (HPV) Among Patients Receiving Colposcopy (NCT NCT04585243)

Last Updated: 2023-10-11

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Within two weeks of their colposcopy exam.

Results posted on

2023-10-11

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-sampling for Human Papillomavirus (HPV) Among Patients Receiving Colposcopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants n=12 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
annual household income <$50,000	2 Participants n=5 Participants
annual household income $50,000 +	9 Participants n=5 Participants
annual household income unknown/not reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within two weeks of their colposcopy exam.

Outcome measures

Outcome measures
Measure	Participants n=12 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.
Number of Participants With Concordance of Screening Results of the Self-Sampling Kit Compared to Clinician-collected Samples	8 Participants

SECONDARY outcome

Timeframe: Within two weeks of their colposcopy exam.

Population: Total number of participants who were provided with a self-sampling kit.

The number of participants provided a kit vs. those who completed the sample collection

Outcome measures

Outcome measures
Measure	Participants n=22 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.
Number of Completed Self-Sampling Kits	12 Participants

SECONDARY outcome

Timeframe: Within two weeks of their colposcopy exam

Population: Total number of participants who returned the self-sampling kit.

The number of participants, among those who completed the sample collection, who reported problems using the self-sampling kit.

Outcome measures

Outcome measures
Measure	Participants n=12 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.
Number of Participants Who Reported Problems Using Self-Sampling Kits	0 Participants

Adverse Events

Participants

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

Jennifer L. Moss, PhD

Pennsylvania State University College of Medicine

Phone: 717-531-0003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place