The Prevent Anal Cancer Palpation Study
Completed · Not applicable
Conditions studied: Anal Cancer
In brief
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.
Key facts
- Study ID
- NCT04090060
- Run by
- Medical College of Wisconsin
- People needed
- 718
- Starts
- 2020-01-17
- Expected to finish
- 2023-06-10
- Last updated by the study team
- 2024-07-09
Who can join
Age: 25 and older. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Chicago or Houston Metro Residents
- Persons who had sex with men in the prior five years
- Cis-gendered men and transgender persons
- Age: 25 years and over
- Access to medical care for referral or treatment
- Spanish or English speakers/readers
- Individuals or couples
- HIV+ or HIV-
- Persons with or without comorbidities and physical disabilities
You may not qualify if…
- Unresolved health care provider's diagnosis of anal condyloma, hemorrhoids or anal cancer
- DARE in the prior three months
- Plans to move in the following six months
Where it is running
- University of Chicago — Chicago, Illinois, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- M.D. Anderson Cancer Center — Houston, Texas, United States
- Gordon Crofoot MD — Houston, Texas, United States
Full record on ClinicalTrials.gov
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