Anal Cancer
Conditions
Keywords
anal cancer, human papillomavirus
Brief summary
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.
Interventions
BEHAVIORALSelf-sampling
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.
OTHERNylon-flocked Swab
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.
Sponsors
National Cancer Institute (NCI)
University of Chicago
Froedtert Hospital
The University of Texas MD Anderson Cancer Center
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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: 1. Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative. 2. Must be either: 1. A cisgender or transgender sexual minority man, or 2. A transgender woman who has sex with men. 3. Resides in Chicago, Houston, or Milwaukee metropolitan area. 4. Is willing to attend a study clinic. 5. Speak and understand either English or Spanish 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the self-sampling intervention at cytology | 1 month | Determine the number of individuals who attend the cytology appointment after exposure to the self-sampling intervention. |
| Effect of self-sampling intervention at high-resolution anoscopy | 2 months | Determine the number of individuals who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the self-sampling intervention at cytology on people with human immunodeficiency virus (HIV) | 1 month | Determine the number of individuals with HIV who attend the cytology appointment after exposure to the self-sampling intervention. |
| Effect of the self-sampling intervention at high-resolution anoscopy on people with HIV | 2 months | Determine the number of individuals with HIV who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention. |
| Effect of the self-sampling intervention at cytology on people randomized to their preferred sampling method | 1 month | Assess the number of participants who attend their cytology appointment in the group randomized to their preferred sampling method. |
| Effect of the self-sampling intervention at high-resolution anoscopy on people randomized to their preferred sampling method | 2 months | Assess the number of participants who attend their high-resolution anoscopy appointment in the group randomized to their preferred sampling method. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess participant comfort after using the nylon-flocked swab | 1 month | 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. |
| Effect of the self-sampling intervention among Black individuals at cytology | 1 month | Determine the number of Black individuals who attend the cytology appointment after exposure to the self-sampling intervention. |
| Assess participant comfort after using the Dacron swab | 1 month | 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 |
| Effect of the self-sampling intervention among Black individuals at high-resolution anoscopy | 2 months | Determine the number of Black individuals who attend high-resolution anoscopy appointments after exposure to the self-sampling intervention. |
| Assess the adequacy of nylon-flocked swabs | 1 month | Determine the number of nylon-flocked swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3). |
| Assess the adequacy of Dacron swabs | 1 month | Determine the number of Dacron swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3). |
| Assess participant pain after using the nylon-flocked swab | 1 month | The Wong-Baker FACES® 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. |
| Assess participant pain after using the Dacron swab | 1 month | The Wong-Baker FACES® 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. |
Countries
United States
Contacts
Primary ContactAlan G Nyitray, PhD
Backup ContactJenna Nitkowski, PhD
Outcome results
None listed