The Prevent Anal Cancer Self-Swab Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-09

Study Completion Date

2023-08-31

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.

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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 (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.

Conditions

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Anal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Home-based human papillomavirus (HPV) DNA screening

Intervention Type BEHAVIORAL

Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail 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.

Group Type ACTIVE_COMPARATOR

Clinic-based human papillomavirus (HPV) DNA screening

Intervention Type BEHAVIORAL

Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes