Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Compliance With Annual Anal HPV DNA Screening
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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-
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Home-based human papillomavirus (HPV) DNA screening (Behavioral)
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.
干预措施: Clinic-based human papillomavirus (HPV) DNA screening (Behavioral)
结局指标
主要结局
Compliance With Annual Anal HPV DNA Screening
时间窗: 12 months
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Compliance With Annual Anal HPV DNA Screening
时间窗: Baseline
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
次要结局
- Compliance With Annual Screening Based on HIV Status(12 months 12 months)
- Compliance With Annual Screening Based on Race/Ethnicity(12 months)
- Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity(12 months)
- Number of Participants Attending High-resolution Anoscopy Based on HIV Status(12 months)
- Attendance at High-resolution Anoscopy(12 months)
研究者
Alan Nyitray, PhD
Associate Professor
Medical College of Wisconsin