Trial Outcomes & Findings for The Prevent Anal Cancer Self-Swab Study (NCT NCT03489707)
NCT ID: NCT03489707
Last Updated: 2024-11-12
Results Overview
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
253 participants
Primary outcome timeframe
Baseline
Results posted on
2024-11-12
Participant Flow
Participant milestones
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
|---|---|---|
|
Baseline
STARTED
|
120
|
120
|
|
Baseline
COMPLETED
|
107
|
89
|
|
Baseline
NOT COMPLETED
|
13
|
31
|
|
12 Months
STARTED
|
120
|
120
|
|
12 Months
COMPLETED
|
78
|
63
|
|
12 Months
NOT COMPLETED
|
42
|
57
|
Reasons for withdrawal
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
|---|---|---|
|
Baseline
These individuals simply did not comply with baseline screening in this compliance study.
|
13
|
31
|
|
12 Months
These individuals simply did not comply with 12-month screening in this compliance study.
|
42
|
57
|
Baseline Characteristics
The Prevent Anal Cancer Self-Swab Study
Baseline characteristics by cohort
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
113 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex/Gender, Customized
Man
|
115 participants
n=5 Participants
|
112 participants
n=7 Participants
|
227 participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans Man
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans Woman
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
120 participants
n=7 Participants
|
240 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: One-hundred and seven of 120 in the Home-Based arm and 89 of 120 in the Clinic-based arm complied at Baseline by providing specimens for annual anal HPV DNA screening (Primary Outcome Measure 1).
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Outcome measures
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score
Participants who have both high-resolution anoscopy biopsy histology result \& methylation score who were also randomized to the clinic-based arm.
|
|---|---|---|---|
|
Compliance With Annual Anal HPV DNA Screening
Provided specimens
|
107 Participants
|
89 Participants
|
—
|
|
Compliance With Annual Anal HPV DNA Screening
Did not provide specimens
|
13 Participants
|
31 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Seventy-eight of 120 in the Home-Based arm and 63 of 120 in the Clinic-based arm complied at 12-months by providing specimens for annual anal HPV DNA screening (Primary Outcome Measure 2).
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Outcome measures
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score
Participants who have both high-resolution anoscopy biopsy histology result \& methylation score who were also randomized to the clinic-based arm.
|
|---|---|---|---|
|
Compliance With Annual Anal HPV DNA Screening
Provided specimens
|
78 Participants
|
63 Participants
|
—
|
|
Compliance With Annual Anal HPV DNA Screening
Did not provide specimens
|
42 Participants
|
57 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 months 12 monthsPopulation: The row totals for each column equal the overall number of participants analyzed (the arm totals/column totals).
The number of participants complying with annual screening with positive or negative HIV status. Compliance is defined as screening at baseline and one year.
Outcome measures
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score
Participants who have both high-resolution anoscopy biopsy histology result \& methylation score who were also randomized to the clinic-based arm.
|
|---|---|---|---|
|
Compliance With Annual Screening Based on HIV Status
HIV-positive · Provided specimens
|
27 Participants
|
6 Participants
|
—
|
|
Compliance With Annual Screening Based on HIV Status
HIV-positive · Did not provide specimens
|
11 Participants
|
21 Participants
|
—
|
|
Compliance With Annual Screening Based on HIV Status
HIV-negative · Provided specimens
|
51 Participants
|
57 Participants
|
—
|
|
Compliance With Annual Screening Based on HIV Status
HIV-negative · Did not provide specimens
|
31 Participants
|
36 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The row totals for each column, equal the overall number of participants analyzed (the arm totals/column totals).
The number of participants complying with annual screening based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White. Compliance is defined as screening at baseline and one year.
Outcome measures
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score
Participants who have both high-resolution anoscopy biopsy histology result \& methylation score who were also randomized to the clinic-based arm.
|
|---|---|---|---|
|
Compliance With Annual Screening Based on Race/Ethnicity
I don't know/Not Reported · Provided specimens
|
1 Participants
|
0 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
I don't know/Not Reported · Did not provide specimens
|
1 Participants
|
0 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
Other · Provided specimens
|
0 Participants
|
1 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
Other · Did not provide specimens
|
0 Participants
|
1 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
White/Non Hispanic · Provided specimens
|
49 Participants
|
50 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
White/Non Hispanic · Did not provide specimens
|
27 Participants
|
32 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
Black/Non-Hispanic · Provided specimens
|
19 Participants
|
6 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
Black/Non-Hispanic · Did not provide specimens
|
7 Participants
|
13 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
Hispanic · Provided specimens
|
9 Participants
|
6 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
Hispanic · Did not provide specimens
|
6 Participants
|
10 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
Asian (Not Hispanic or Latino) · Provided specimens
|
0 Participants
|
0 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
Asian (Not Hispanic or Latino) · Did not provide specimens
|
1 Participants
|
0 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
American Indian/Alaskan Native (Not Hispanic or Latino) · Provided specimens
|
0 Participants
|
0 Participants
|
—
|
|
Compliance With Annual Screening Based on Race/Ethnicity
American Indian/Alaskan Native (Not Hispanic or Latino) · Did not provide specimens
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The row totals for each column equal the overall number of participants analyzed (the arm totals/column totals).
The number of participants attending high-resolution anoscopy based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White.
Outcome measures
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score
Participants who have both high-resolution anoscopy biopsy histology result \& methylation score who were also randomized to the clinic-based arm.
|
|---|---|---|---|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
Hispanic · Did not attend HRA
|
6 Participants
|
9 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
I don't know/Not reported · Did not attend HRA
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
White/Non-Hispanic · Attended HRA
|
41 Participants
|
54 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
White/Non-Hispanic · Did not attend HRA
|
35 Participants
|
28 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
Black/Non-Hispanic · Attended HRA
|
11 Participants
|
8 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
Black/Non-Hispanic · Did not attend HRA
|
15 Participants
|
11 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
Hispanic · Attended HRA
|
9 Participants
|
7 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
Asian (Not Hispanic or Latino) · Attended HRA
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
Asian (Not Hispanic or Latino) · Did not attend HRA
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
American Indian/Alaskan Native (Not Hispanic or Latino) · Attended HRA
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
American Indian/Alaskan Native (Not Hispanic or Latino) · Did not attend HRA
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
Other (Not Hispanic or Latino) · Attended HRA
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
Other (Not Hispanic or Latino) · Did not attend HRA
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
I don't know/Not reported · Attended HRA
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The row totals for each column, equal the overall number of participants analyzed (the arm totals/column totals).
The number of participants attending high-resolution anoscopy based on positive or negative HIV status.
Outcome measures
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score
Participants who have both high-resolution anoscopy biopsy histology result \& methylation score who were also randomized to the clinic-based arm.
|
|---|---|---|---|
|
Number of Participants Attending High-resolution Anoscopy Based on HIV Status
HIV-positive · Attended HRA
|
20 Participants
|
12 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on HIV Status
HIV-positive · Did not attend HRA
|
18 Participants
|
15 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on HIV Status
HIV-negative · Attended HRA
|
42 Participants
|
59 Participants
|
—
|
|
Number of Participants Attending High-resolution Anoscopy Based on HIV Status
HIV-negative · Did not attend HRA
|
40 Participants
|
34 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Sixty-two of 120 home-based participants and 71 of 120 clinic-based participants attended HRA.
Number of participants who attend high-resolution anoscopy (HRA)
Outcome measures
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score
Participants who have both high-resolution anoscopy biopsy histology result \& methylation score who were also randomized to the clinic-based arm.
|
|---|---|---|---|
|
Attendance at High-resolution Anoscopy
Attended HRA
|
62 Participants
|
71 Participants
|
—
|
|
Attendance at High-resolution Anoscopy
Did not attend HRA
|
58 Participants
|
49 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Only participants who provided a swab at both baseline and 12 months are assessed for high-risk HPV DNA persistence. Only those assessed for high-risk persistence are included the analysis of the number of high-grade squamous intraepithelial lesions.
The number of participants that have DNA persistence at 12 months with and without high-grade squamous intraepithelial lesions (HSIL).
Outcome measures
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=120 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score
Participants who have both high-resolution anoscopy biopsy histology result \& methylation score who were also randomized to the clinic-based arm.
|
|---|---|---|---|
|
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
Did not attend HRA (preventing HSIL assessment)
|
58 Participants
|
49 Participants
|
—
|
|
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
Attended HRA
|
62 Participants
|
71 Participants
|
—
|
|
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
Assessed for persistence
|
60 Participants
|
55 Participants
|
—
|
|
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
Persistent
|
36 Participants
|
17 Participants
|
—
|
|
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
persistent ≥HSIL
|
14 Participants
|
9 Participants
|
—
|
|
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
persistent <HSIL
|
22 Participants
|
8 Participants
|
—
|
|
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
Not persistent
|
24 Participants
|
38 Participants
|
—
|
|
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
not persistent ≥HSIL
|
3 Participants
|
4 Participants
|
—
|
|
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
not persistent < HSIL
|
21 Participants
|
34 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Participants who have both high-resolution anoscopy histology result \& methylation score (n=133 of 240 total participants) are analyzed here, whether or not they were analyzed for high-risk HPV persistence. Participants who do not have both high-resolution anoscopy biopsy histology result \& methylation score = 107 of 240 total participants.
Mean of host/viral methylation score among participants stratified by high-grade squamous intraepithelial lesions. The Score 5 (S5) methylation score is an arithmetic continuous risk score with a minimum value of 0 and no maximum value. Higher methylation scores indicate higher risk for disease. While a theoretical maximum for a methylation score does not exist, one published maximum value for anal cancer is approximately 100. In this publication (Lorincz et al., Methylation of HPV and a tumor suppressor gene reveals anal cancer and precursor lesions, DOI: 10.18632/oncotarget.17984), a cut-off of 7.5 for methylation score identified all anal cancers and HSIL.
Outcome measures
| Measure |
Home-based Human Papillomavirus (HPV) DNA Screening
n=133 Participants
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Home-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening
n=63 Participants
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screening: Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
|
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score
n=70 Participants
Participants who have both high-resolution anoscopy biopsy histology result \& methylation score who were also randomized to the clinic-based arm.
|
|---|---|---|---|
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Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions.
≥HSIL
|
6.98 scores on a scale
Standard Deviation 5.89
|
6.99 scores on a scale
Standard Deviation 6.70
|
6.96 scores on a scale
Standard Deviation 4.99
|
|
Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions.
<HSIL
|
3.31 scores on a scale
Standard Deviation 2.92
|
3.58 scores on a scale
Standard Deviation 2.97
|
3.10 scores on a scale
Standard Deviation 2.90
|
Adverse Events
Home-based Human Papillomavirus (HPV) DNA Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinic-based Human Papillomavirus (HPV) DNA Screening
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