The Prevent Anal Cancer Self-Swab Study

Study Overview
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Brief Summary
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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
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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 and transpersons 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 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 transpersons; 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.

Official Title
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Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer

Conditions
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Anal Cancer

Intervention / Treatment
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* Behavioral: Home-based human papillomavirus (HPV) DNA screening
* Behavioral: Clinic-based human papillomavirus (HPV) DNA screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based human papillomavirus (HPV) DNA screening<br>Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. | Behavioral: Home-based human papillomavirus (HPV) DNA screening<br>* Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.<br>|
| Active Comparator: Clinic-based human papillomavirus (HPV) DNA screening<br>Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. | Behavioral: Clinic-based human papillomavirus (HPV) DNA screening<br>* Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening | Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening | baseline | 
| Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening | Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire (pre-test) | Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire (pre-test) | about a week before the first DNA screening | 
| Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire | Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire | about 1 hour after the first DNA screening | 
| Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire | Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire | about 1 hour after the 12 month DNA screening | 
| Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire | Factors associated with HRA compliance as assessed by the Computer-Assisted Self-Interview (CASI) | about 1 hour after the HRA (HRA occurs about 2 weeks after the 12-month DNA screening) | 
| Number of participants who agree to have a high resolution anoscopy (HRA) | Number of participants who agree to have a high resolution anoscopy (HRA) | 2 weeks after the 12-month DNA screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal cancer, human papillomavirus