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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA298844 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Chicago | OTHER |
| Froedtert Hospital | OTHER |
| M.D. Anderson Cancer Center |
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The purpose of this research study is to find ways to increase anal cancer screening among people at increased risk for anal cancer. This study will try to find out if persons will do an intervention (self-sampling of the anal canal) and if it affects cytology and high-resolution anoscopy (HRA) appointment attendance. Secondarily, the study will assess if a person who gets their choice of either self-sampling or healthcare provider sampling affects clinic attendance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-sampling | Experimental | Participants will self-sample the anal canal with a swab. They will do this at home and at a clinic. |
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| Clinician sampling | Active Comparator | A clinician will collect a sample from the anal canal of the participant with a swab. They will do this at the clinic. |
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| Nylon-flocked swab | Experimental | This is a swab with nylon-flocked material at the tip. |
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| Dacron swab | Active Comparator | This is a swab with a Dacron tip. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-sampling | Behavioral | Self-sampling instructions will be provided to participants who will insert the swab into the anus to collect cells. Then the participant will put the swab in a vial of transport fluid for assessment at a laboratory. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the self-sampling intervention at cytology | Determine the number of individuals who attend the cytology appointment after exposure to the self-sampling intervention. | 1 month |
| Effect of self-sampling intervention at high-resolution anoscopy | Determine the number of individuals who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the self-sampling intervention at cytology on people with human immunodeficiency virus (HIV) | Determine the number of individuals with HIV who attend the cytology appointment after exposure to the self-sampling intervention. | 1 month |
| Effect of the self-sampling intervention at high-resolution anoscopy on people with HIV |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the self-sampling intervention among Black individuals at cytology | Determine the number of Black individuals who attend the cytology appointment after exposure to the self-sampling intervention. | 1 month |
| Effect of the self-sampling intervention among Black individuals at high-resolution anoscopy |
A potential study subject who meets all of the following inclusion criteria is eligible to participate in the study. Note that these criteria apply regardless of HPV vaccination status or disability status.
Inclusion Criteria:
Age ā„ 35 years for those who are HIV-positive or ā„ 45 years for those who are HIV-negative.
Must be either:
Resides in Chicago, Houston, or Milwaukee metropolitan area.
Is willing to attend a study clinic.
Speak and understand either English or Spanish
Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
cisgender males and transgender persons who have sex with men
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alan G Nyitray, PhD | Contact | 4149557701 | anyitray@mcw.edu | |
| Jenna Nitkowski, PhD | Contact | 414-955-2126 | jnitkowski@mcw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alan Nyitray, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.
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Data will become available one year after study completion.
Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| OTHER |
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When care providers are scheduling cytology appointments, they will not know the participant arm assignment. When specimens are sent to laboratories, the lab will not know the participant arm assignment.
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| Nylon-flocked Swab | Other | At the cytology appointment, participants may receive self-sampling or clinician sampling with 1 of 2 kinds of swabs. The nylon-flocked swab is the intervention and will be assessed on patient acceptability and patient and clinician ability to collect an adequate sample. |
|
Determine the number of individuals with HIV who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention. |
| 2 months |
| Effect of the self-sampling intervention at cytology on people randomized to their preferred sampling method | Assess the number of participants who attend their cytology appointment in the group randomized to their preferred sampling method. | 1 month |
| Effect of the self-sampling intervention at high-resolution anoscopy on people randomized to their preferred sampling method | Assess the number of participants who attend their high-resolution anoscopy appointment in the group randomized to their preferred sampling method. | 2 months |
Determine the number of Black individuals who attend high-resolution anoscopy appointments after exposure to the self-sampling intervention. |
| 2 months |
| Assess the adequacy of nylon-flocked swabs | Determine the number of nylon-flocked swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3). | 1 month |
| Assess the adequacy of Dacron swabs | Determine the number of Dacron swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3). | 1 month |
| Assess participant pain after using the nylon-flocked swab | The Wong-Baker FACESĀ® Pain Rating Scale measures the severity of pain, if any. Possible scores range from 0 to 10 with higher scores indicating increased severity of pain. | 1 month |
| Assess participant pain after using the Dacron swab | The Wong-Baker FACESĀ® Pain Rating Scale measures the severity of pain, if any. Possible scores range from 0 to 10 with higher scores indicating increased severity of pain. | 1 month |
| Assess participant comfort after using the nylon-flocked swab | The variable comfort measures the individual's reported comfort on a 4-point Likert scale from Strongly Agree to Strongly Disagree. Possible scores range from 1 to 4 with higher scores indicating decreased comfort after using the nylon-flocked swab. | 1 month |
| Assess participant comfort after using the Dacron swab | The variable comfort measures the individual's reported comfort on a 4-point Likert scale from Strongly Agree to Strongly Disagree. Possible scores range from 1 to 4 with higher scores indicating decreased comfort after using the Dacron swab | 1 month |
| The University of Texas M.D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |