The Prevent Anal Cancer Palpation Study

University of Chicago, M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, Gordon Crofoot MD PA, National Cancer Institute (NCI)

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.

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 HCP exam. Regardless of prior results, all persons will be asked to return for Visit 2.

Subjects will be randomly assigned to groups encouraged to practice anal examination (Experimental) or not encouraged to practice anal examinations (Control).

300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.

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.

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.

This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.

This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.

This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.

This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.

This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 180.

This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 180.

Differences in outcome measures 1-6, and 9 will be compared for subjects living in the Chicago and Houston metropolitan areas.

Differences in outcome measures 1-6, and 9 will be compared for companions living in the Chicago and Houston metropolitan areas.

This measure will record subject waist circumference in cm and assess its association with OM 1 on Day 1.

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