Clinical trial NCT04090060: The Prevent Anal Cancer Palpation Study
Official title: Determining the Accuracy of Self and Partner Anal Exams for Detecting Anal Abnormalities.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Cancer
Keywords: Anus neoplasm
Digital anal rectal examination
Self anal examination
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: M.D. Anderson Cancer Center
name: The University of Texas Health Science Center, Houston
name: Gordon Crofoot MD PA
name: National Cancer Institute (NCI)
First posted: 2019-09-16
Enrollment: 718
Sex: MALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to groups encouraged to practice anal examination (Experimental) or not encouraged to practice anal examinations (Control).
Primary purpose: SCREENING

Brief 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.

Detailed description: Even though expert opinion recommends annual digital ano-rectal exams (DARE) for detection of anal cancer tumors among men having sex with men (MSM), the procedure is severely underutilized by clinicians and it is not known how to increase utilization. This is problematic in the context of an extremely high incidence of anal cancer among MSM, no proven treatment for anal precancerous lesions, and lack of screening infrastructure for detecting precancerous lesions, even in high-resource countries.

The long-term goal of this study is to decrease morbidity and mortality from anal cancer by increasing detection of anal canal tumors through self- or partner-palpation of the anal canal. Preliminary data indicate these exams are feasible and highly acceptable among MSM. In a diverse sample of 200 MSM, 93% of men correctly classified their anal self-exam (ASE) or anal companion exam (ACE) as either normal or abnormal, and 94% said the exams were acceptable. Given these findings, our overall objective is to determine the viability of the ASE and ACE by assessing exam accuracy and consistency of results in two clinic sites. Accuracy will be defined as concordance between clinician DARE and participant exam. The central 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. We will test the hypothesis with three specific aims: 1) Estimate ASE and ACE sensitivity and specificity; 2) Determine independent factors associated with ASE and ACE concordance; and 3) Determine the impact of ASE, ACE, and DARE on survival and quality of life, and evaluate the cost-effectiveness of these strategies among HIV+ and HIV- MSM and transgender persons. The aims will be accomplished with a study in Houston and Chicago with a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged \>=25 years, who will perform a clinician-taught ASE or ACE. The individual's ASE and partner's ACE will then be compared with the clinician's DARE. The assessment will be done at each of two visits, spaced six-months apart, to assess retention of exam accuracy.

At the end of visit 1, one-half of participants, i.e., 300 individuals and 50 couples (stratified by city) will be randomly selected and encouraged to practice the ASE/ACE three months before Visit 2. Study staff will make reminder calls (or emails/texts) and follow-up calls for the scheduled practice session. At the follow-up calls, study staff will record the participant's result for the self/companion exam and the level of anxiety and pain, if any, associated with the exam. If the participant reports more than minimal pain and anxiety, they will be asked to return to the clinic for an exam. Regardless of prior results, all persons will be asked to return for Visit 2.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Concordance Between Self-examination and Clinician Examination
timeFrame: Day 1
measure: Concordance Between Self-examination and Clinician Examination
timeFrame: Day 180.
measure: Concordance Between Companion Examination and Clinician Examination
timeFrame: Day 1
measure: Concordance Between Companion Examination and Clinician Examination
timeFrame: Day 180
measure: Number of Persons Who Practice the Self Examination
timeFrame: Day 180
measure: Number of Persons Who Practice the Companion Examination
timeFrame: Day 180
Secondary outcomes:
measure: Measuring the Difference Between Chicago and Houston Self-exam Concordance.
timeFrame: Day 1
measure: Measuring the Difference Between Chicago and Houston Companion Exam Concordance.
timeFrame: Day 1
measure: Waist Circumference for Persons Doing Self-examinations
timeFrame: Day 1
measure: Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference.
timeFrame: Day 1
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Gordon Crofoot MD
state: Texas
Study officials:
affiliation: Medical College of Wisconsin
name: Alan Nyitray, PhD
role: PRINCIPAL_INVESTIGATOR
References: