Anal Cancer
Conditions
Keywords
anal cancer, human papillomavirus
Brief summary
The purpose of this research study is to find ways to screen for anal cancer among gay, bisexual, and other men who have sex with men (MSM) and transgender persons. This study will try to find out if persons will do annual anal cancer screening, what factors are associated with repeated screening, and how this affects a person's decision to have high-resolution anoscopy.
Detailed description
This is a prospective, randomized, two-arm clinical study to evaluate compliance with annual home-based vs clinic-based DNA screening of anal canal exfoliated cells among Milwaukee HIV+ and HIV- men who have sex with men (MSM) and transgender persons aged ≥25 years. At study entry, persons randomized to arm 1 will receive a home-based collection kit in the mail at 0 and 12 months and those in arm 2 will attend a clinic where a clinician will collect the exfoliated cell specimen at 0 and 12 months. Then, persons will receive high-resolution anoscopy (HRA)-directed biopsy to assess precancerous lesions by study arm. We hypothesize that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm vs clinic-based arm. The proposed research could indicate that annual HPV DNA screening and subsequent HRA are acceptable to MSM and transgender persons; thus, we will determine how high-risk persons are identified for HRA in light of limited HRA resources. The duration of each participant's activities is expected to be 12 months. The study is expected have participant activity from 2019 to 2023.
Interventions
BEHAVIORALHome-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.
BEHAVIORALClinic-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.
Sponsors
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be \> 25 years of age * Sex at birth is male or gender identity is a transgender person * Acknowledge sex with men in the last 5 years, or identify as gay or bisexual * Understand and be willing to give informed consent * Be willing to be randomized and able to comply with the protocol * Spanish and/or English speakers/readers, and * HIV+ or HIV-
Exclusion criteria
* Not acknowledge sex with men in the past five years and not identify as gay or bisexual * Use of anticoagulants other than Aspirin or NSAIDS * Prior diagnosis of anal cancer * Plans to move within 12 months * Not Milwaukee metro residents * Not willing to attend one of the designated study clinics at baseline, or * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Annual Anal HPV DNA Screening | Baseline | Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Annual Screening Based on HIV Status | 12 months 12 months | The number of participants complying with annual screening with positive or negative HIV status. Compliance is defined as screening at baseline and one year. |
| Compliance With Annual Screening Based on Race/Ethnicity | 12 months | 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. |
| Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | 12 months | 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. |
| Number of Participants Attending High-resolution Anoscopy Based on HIV Status | 12 months | The number of participants attending high-resolution anoscopy based on positive or negative HIV status. |
| Attendance at High-resolution Anoscopy | 12 months | Number of participants who attend high-resolution anoscopy (HRA) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | 12 months | The number of participants that have DNA persistence at 12 months with and without high-grade squamous intraepithelial lesions (HSIL). |
| Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. | 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 120 |
| 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. | 120 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Months | These individuals simply did not comply with 12-month screening in this compliance study. | 42 | 57 |
| Baseline | These individuals simply did not comply with baseline screening in this compliance study. | 13 | 31 |
Baseline characteristics
| Characteristic | Home-based Human Papillomavirus (HPV) DNA Screening | Clinic-based Human Papillomavirus (HPV) DNA Screening | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 10 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants | 110 Participants | 223 Participants |
| Age, Continuous | 46.5 years STANDARD_DEVIATION 13 | 44.9 years STANDARD_DEVIATION 13.9 | 45.8 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 16 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants | 104 Participants | 208 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 19 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 84 Participants | 91 Participants | 175 Participants |
| Region of Enrollment United States | 120 participants | 120 participants | 240 participants |
| Sex/Gender, Customized Man | 115 participants | 112 participants | 227 participants |
| Sex/Gender, Customized Non-binary | 2 participants | 3 participants | 5 participants |
| Sex/Gender, Customized Other | 0 participants | 1 participants | 1 participants |
| Sex/Gender, Customized Trans Man | 0 participants | 1 participants | 1 participants |
| Sex/Gender, Customized Trans Woman | 3 participants | 3 participants | 6 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 120 |
| other Total, other adverse events | 0 / 120 | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 | 0 / 120 |
Outcome results
Primary
Compliance With Annual Anal HPV DNA Screening
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Time frame: 12 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Anal HPV DNA Screening | Provided specimens | 78 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Anal HPV DNA Screening | Did not provide specimens | 42 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Anal HPV DNA Screening | Provided specimens | 63 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Anal HPV DNA Screening | Did not provide specimens | 57 Participants |
Primary
Compliance With Annual Anal HPV DNA Screening
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Time frame: Baseline
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Anal HPV DNA Screening | Provided specimens | 107 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Anal HPV DNA Screening | Did not provide specimens | 13 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Anal HPV DNA Screening | Provided specimens | 89 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Anal HPV DNA Screening | Did not provide specimens | 31 Participants |
Secondary
Attendance at High-resolution Anoscopy
Number of participants who attend high-resolution anoscopy (HRA)
Time frame: 12 months
Population: Sixty-two of 120 home-based participants and 71 of 120 clinic-based participants attended HRA.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home-based Human Papillomavirus (HPV) DNA Screening | Attendance at High-resolution Anoscopy | Attended HRA | 62 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Attendance at High-resolution Anoscopy | Did not attend HRA | 58 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Attendance at High-resolution Anoscopy | Attended HRA | 71 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Attendance at High-resolution Anoscopy | Did not attend HRA | 49 Participants |
Secondary
Compliance With Annual Screening Based on HIV Status
The number of participants complying with annual screening with positive or negative HIV status. Compliance is defined as screening at baseline and one year.
Time frame: 12 months 12 months
Population: The row totals for each column equal the overall number of participants analyzed (the arm totals/column totals).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on HIV Status | HIV-positive | Provided specimens | 27 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on HIV Status | HIV-positive | Did not provide specimens | 11 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on HIV Status | HIV-negative | Provided specimens | 51 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on HIV Status | HIV-negative | Did not provide specimens | 31 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on HIV Status | HIV-negative | Did not provide specimens | 36 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on HIV Status | HIV-positive | Provided specimens | 6 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on HIV Status | HIV-negative | Provided specimens | 57 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on HIV Status | HIV-positive | Did not provide specimens | 21 Participants |
Secondary
Compliance With Annual Screening Based on Race/Ethnicity
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.
Time frame: 12 months
Population: The row totals for each column, equal the overall number of participants analyzed (the arm totals/column totals).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | White/Non Hispanic | Provided specimens | 49 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | White/Non Hispanic | Did not provide specimens | 27 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Black/Non-Hispanic | Provided specimens | 19 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Black/Non-Hispanic | Did not provide specimens | 7 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Hispanic | Provided specimens | 9 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Hispanic | Did not provide specimens | 6 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Asian (Not Hispanic or Latino) | Provided specimens | 0 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Asian (Not Hispanic or Latino) | Did not provide specimens | 1 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | American Indian/Alaskan Native (Not Hispanic or Latino) | Provided specimens | 0 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | American Indian/Alaskan Native (Not Hispanic or Latino) | Did not provide specimens | 0 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | I don't know/Not Reported | Provided specimens | 1 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | I don't know/Not Reported | Did not provide specimens | 1 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Other | Provided specimens | 0 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Other | Did not provide specimens | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | I don't know/Not Reported | Provided specimens | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | White/Non Hispanic | Provided specimens | 50 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Asian (Not Hispanic or Latino) | Did not provide specimens | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | White/Non Hispanic | Did not provide specimens | 32 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Other | Provided specimens | 1 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Black/Non-Hispanic | Provided specimens | 6 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | American Indian/Alaskan Native (Not Hispanic or Latino) | Provided specimens | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Black/Non-Hispanic | Did not provide specimens | 13 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | I don't know/Not Reported | Did not provide specimens | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Hispanic | Provided specimens | 6 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | American Indian/Alaskan Native (Not Hispanic or Latino) | Did not provide specimens | 1 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Hispanic | Did not provide specimens | 10 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Other | Did not provide specimens | 1 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Compliance With Annual Screening Based on Race/Ethnicity | Asian (Not Hispanic or Latino) | Provided specimens | 0 Participants |
Secondary
Number of Participants Attending High-resolution Anoscopy Based on HIV Status
The number of participants attending high-resolution anoscopy based on positive or negative HIV status.
Time frame: 12 months
Population: The row totals for each column, equal the overall number of participants analyzed (the arm totals/column totals).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on HIV Status | HIV-positive | Attended HRA | 20 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on HIV Status | HIV-positive | Did not attend HRA | 18 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on HIV Status | HIV-negative | Attended HRA | 42 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on HIV Status | HIV-negative | Did not attend HRA | 40 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on HIV Status | HIV-negative | Did not attend HRA | 34 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on HIV Status | HIV-positive | Attended HRA | 12 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on HIV Status | HIV-negative | Attended HRA | 59 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on HIV Status | HIV-positive | Did not attend HRA | 15 Participants |
Secondary
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
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.
Time frame: 12 months
Population: The row totals for each column equal the overall number of participants analyzed (the arm totals/column totals).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | White/Non-Hispanic | Attended HRA | 41 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | White/Non-Hispanic | Did not attend HRA | 35 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Black/Non-Hispanic | Attended HRA | 11 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Black/Non-Hispanic | Did not attend HRA | 15 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Hispanic | Attended HRA | 9 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Hispanic | Did not attend HRA | 6 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Asian (Not Hispanic or Latino) | Attended HRA | 0 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Asian (Not Hispanic or Latino) | Did not attend HRA | 1 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | American Indian/Alaskan Native (Not Hispanic or Latino) | Attended HRA | 0 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | 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 |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Other (Not Hispanic or Latino) | Attended HRA | 0 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Other (Not Hispanic or Latino) | Did not attend HRA | 1 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | I don't know/Not reported | Attended HRA | 1 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | I don't know/Not reported | Did not attend HRA | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Other (Not Hispanic or Latino) | Attended HRA | 2 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | White/Non-Hispanic | Attended HRA | 54 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Asian (Not Hispanic or Latino) | Did not attend HRA | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | White/Non-Hispanic | Did not attend HRA | 28 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | I don't know/Not reported | Attended HRA | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Black/Non-Hispanic | Attended HRA | 8 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | American Indian/Alaskan Native (Not Hispanic or Latino) | Attended HRA | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Black/Non-Hispanic | Did not attend HRA | 11 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Other (Not Hispanic or Latino) | Did not attend HRA | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Hispanic | Attended HRA | 7 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | American Indian/Alaskan Native (Not Hispanic or Latino) | Did not attend HRA | 1 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Hispanic | Did not attend HRA | 9 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | I don't know/Not reported | Did not attend HRA | 0 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity | Asian (Not Hispanic or Latino) | Attended HRA | 0 Participants |
Other Pre-specified
Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions.
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based Human Papillomavirus (HPV) DNA Screening | Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. | ≥HSIL | 6.98 scores on a scale | Standard Deviation 5.89 |
| Home-based Human Papillomavirus (HPV) DNA Screening | Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. | <HSIL | 3.31 scores on a scale | Standard Deviation 2.92 |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. | ≥HSIL | 6.99 scores on a scale | Standard Deviation 6.7 |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. | <HSIL | 3.58 scores on a scale | Standard Deviation 2.97 |
| Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score | Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. | ≥HSIL | 6.96 scores on a scale | Standard Deviation 4.99 |
| Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score | Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. | <HSIL | 3.10 scores on a scale | Standard Deviation 2.9 |
Other Pre-specified
Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL).
The number of participants that have DNA persistence at 12 months with and without high-grade squamous intraepithelial lesions (HSIL).
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | not persistent ≥HSIL | 3 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Assessed for persistence | 60 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Did not attend HRA (preventing HSIL assessment) | 58 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Persistent | 36 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | not persistent < HSIL | 21 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | persistent ≥HSIL | 14 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Attended HRA | 62 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | persistent <HSIL | 22 Participants |
| Home-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Not persistent | 24 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | persistent <HSIL | 8 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Not persistent | 38 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | not persistent ≥HSIL | 4 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | not persistent < HSIL | 34 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Did not attend HRA (preventing HSIL assessment) | 49 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Attended HRA | 71 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Assessed for persistence | 55 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | Persistent | 17 Participants |
| Clinic-based Human Papillomavirus (HPV) DNA Screening | Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). | persistent ≥HSIL | 9 Participants |