Trial Outcomes & Findings for The Self-Sampling Pilot Study (NCT NCT07085845)
NCT ID: NCT07085845
Last Updated: 2026-01-27
Results Overview
The presence of cells from the squamocolumnar junction will be assessed in each specimen (Yes/No). Proportions of specimens with squamocolumnar cells will be compared for the 5 cm and 3 cm swabs.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Day 1
Results posted on
2026-01-27
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Individuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.
|
Control Arm
Individuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
27
|
|
Overall Study
COMPLETED
|
23
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Self-Sampling Pilot Study
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=23 Participants
Individuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.
|
Control Arm
n=27 Participants
Individuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 Years
STANDARD_DEVIATION 10.4 • n=25 Participants
|
56.1 Years
STANDARD_DEVIATION 11.6 • n=25 Participants
|
55.3 Years
STANDARD_DEVIATION 11.0 • n=50 Participants
|
|
Sex/Gender, Customized
Man
|
23 Participants
n=25 Participants
|
26 Participants
n=25 Participants
|
49 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Trans Man
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
5 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=25 Participants
|
22 Participants
n=25 Participants
|
41 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
46 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=25 Participants
|
27 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Day 1The presence of cells from the squamocolumnar junction will be assessed in each specimen (Yes/No). Proportions of specimens with squamocolumnar cells will be compared for the 5 cm and 3 cm swabs.
Outcome measures
| Measure |
Intervention Arm
n=23 Participants
Individuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.
Inserting a swab 5 cm into the anus during self-sampling: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 5 cm to collect anal exfoliated cells.
|
Control Arm
n=27 Participants
Individuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.
Self-sampling with a swab by inserting the swab 3 cm into the anus.: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 3 cm to collect anal exfoliated cells.
|
|---|---|---|
|
Presence of Squamocolumnar Cells
Presence of squamocolumnar cells - Yes
|
11 Participants
|
8 Participants
|
|
Presence of Squamocolumnar Cells
Presence of squamocolumnar cells - No
|
12 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 1The presence of \~2000-3000 nucleated squamous cells will be assessed for cytologic adequacy (Yes/No). Proportions of adequate specimens will be compared for the 5 cm and 3 cm swabs.
Outcome measures
| Measure |
Intervention Arm
n=23 Participants
Individuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.
Inserting a swab 5 cm into the anus during self-sampling: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 5 cm to collect anal exfoliated cells.
|
Control Arm
n=27 Participants
Individuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.
Self-sampling with a swab by inserting the swab 3 cm into the anus.: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 3 cm to collect anal exfoliated cells.
|
|---|---|---|
|
Cytologic Adequacy
Cytologic adequacy - No
|
3 Participants
|
8 Participants
|
|
Cytologic Adequacy
Cytologic adequacy - Yes
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 1Each participant will receive a short cytology CASI immediately after the cytology screening to rate their acceptability of the cytology screening on a Likert scale. Proportions of individuals' ratings for acceptability will be compared for the new NF swab vs the swab from the prior research.
Outcome measures
| Measure |
Intervention Arm
n=23 Participants
Individuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.
Inserting a swab 5 cm into the anus during self-sampling: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 5 cm to collect anal exfoliated cells.
|
Control Arm
n=27 Participants
Individuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.
Self-sampling with a swab by inserting the swab 3 cm into the anus.: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 3 cm to collect anal exfoliated cells.
|
|---|---|---|
|
User Acceptability of New NF Swab Compared to Swab From Prior Research
Willing to do anal self-swabbing in the future - Strongly agree
|
13 Participants
|
21 Participants
|
|
User Acceptability of New NF Swab Compared to Swab From Prior Research
Willing to do anal self-swabbing in the future - Agree
|
10 Participants
|
6 Participants
|
|
User Acceptability of New NF Swab Compared to Swab From Prior Research
Willing to do anal self-swabbing in the future - Disagree
|
0 Participants
|
0 Participants
|
|
User Acceptability of New NF Swab Compared to Swab From Prior Research
Willing to do anal self-swabbing in the future - Strongly Disagree
|
0 Participants
|
0 Participants
|
|
User Acceptability of New NF Swab Compared to Swab From Prior Research
Willing to do anal self-swabbing in the future - Don't know
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Each participant will receive a short cytology CASI immediately after the cytology screening to rate their pain during the cytology screening on a visual scale. Proportions of individuals' ratings for pain will be compared for the new NF swab vs the swab from the prior research.
Outcome measures
| Measure |
Intervention Arm
n=23 Participants
Individuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.
Inserting a swab 5 cm into the anus during self-sampling: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 5 cm to collect anal exfoliated cells.
|
Control Arm
n=27 Participants
Individuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.
Self-sampling with a swab by inserting the swab 3 cm into the anus.: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 3 cm to collect anal exfoliated cells.
|
|---|---|---|
|
User Pain of New NF Swab Compared to Swab From Prior Research
No pain
|
12 Participants
|
15 Participants
|
|
User Pain of New NF Swab Compared to Swab From Prior Research
A little pain
|
9 Participants
|
10 Participants
|
|
User Pain of New NF Swab Compared to Swab From Prior Research
A little more pain
|
1 Participants
|
1 Participants
|
|
User Pain of New NF Swab Compared to Swab From Prior Research
Even more pain
|
1 Participants
|
1 Participants
|
|
User Pain of New NF Swab Compared to Swab From Prior Research
A whole lot of pain
|
0 Participants
|
0 Participants
|
|
User Pain of New NF Swab Compared to Swab From Prior Research
Worst pain
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Each participant will receive a short cytology CASI immediately after the cytology screening to rate their pain during the cytology screening on a visual scale. Proportions of individuals' ratings for pain will be compared for the 5 cm and 3 cm swabs.
Outcome measures
| Measure |
Intervention Arm
n=23 Participants
Individuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.
Inserting a swab 5 cm into the anus during self-sampling: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 5 cm to collect anal exfoliated cells.
|
Control Arm
n=27 Participants
Individuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.
Self-sampling with a swab by inserting the swab 3 cm into the anus.: The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 3 cm to collect anal exfoliated cells.
|
|---|---|---|
|
User Pain by Swab Length
No pain
|
12 Participants
|
15 Participants
|
|
User Pain by Swab Length
A little pain
|
9 Participants
|
10 Participants
|
|
User Pain by Swab Length
A little more pain
|
1 Participants
|
1 Participants
|
|
User Pain by Swab Length
Even more pain
|
1 Participants
|
1 Participants
|
|
User Pain by Swab Length
A whole lot of pain
|
0 Participants
|
0 Participants
|
|
User Pain by Swab Length
Worst pain
|
0 Participants
|
0 Participants
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place