The Prevent Anal Cancer Palpation Study

Summary

Anal cancer is a common cancer among men having sex with men (MSM). We will investigate increasing detection of anal canal tumors through self- or partner-palpation of the anal canal among MSM and trans persons. This study in Houston and Chicago will recruit a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged ≥ 25 years, who will be taught to perform an ASE or ACE. After performing the exam in private, the individual's ASE and partner's ACE will then be compared with a clinician's DARE. The assessment will be done at each of two visits, spaced 6-months apart. One-half of persons will be randomized to a practice condition to assess how practice affects accuracy and retention of exam procedure. Our hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits.

Conditions

• Anal Cancer

Interventions

BEHAVIORAL

Practice Self-/Companion Exams

300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.

BEHAVIORAL

Control Arm

300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.

Sponsors & Collaborators

• University of Chicago

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• Gordon Crofoot MD PA

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  collaborator NIH

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Alan Nyitray, PhD · Medical College of Wisconsin

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-17

Primary Completion

2023-06-10

Completion

2023-06-10

Countries

• United States

Study Locations