Trial Outcomes & Findings for Self-Sampling for Human Papillomavirus (HPV) at Well Women Appointments (NCT NCT04591977)

NCT ID: NCT04591977

Last Updated: 2023-10-06

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: Within two weeks of the well-woman visit
• Results posted on: 2023-10-06

Participant Flow

Participant milestones

Measure	Participants Participants in this group were those scheduled for routine cervical cancer screening.
Overall Study STARTED	46
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Participants n=35 Participants Participants in this group were those scheduled for routine cervical cancer screening.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 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	2 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants
annual household income < $50,000	4 Participants n=5 Participants
annual household income $50,000+	29 Participants n=5 Participants
annual household income unknown/not reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Participants n=35 Participants Participants in this group were those scheduled for routine cervical cancer screening.
Number of Participants With Concordance of Screening Results of the Self-sampling Kit Compared to Clinical-collected Samples	35 Participants

SECONDARY outcome

Timeframe: 28 days (two weeks before or after the well-woman visit)

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

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

Outcome measures

Measure	Participants n=46 Participants Participants in this group were those scheduled for routine cervical cancer screening.
Number of Completed Self-Sampling Kits	35 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Participants n=35 Participants Participants in this group were those scheduled for routine cervical cancer screening.
Number of Participants Who Reported Problems With 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: 7175310003

Email: jmoss1@pennstatehealth.psu.edu

Results disclosure agreements

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