The Prevent Anal Cancer Palpation Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determining the Accuracy of Self and Partner Anal Exams for Detecting Anal Abnormalities.

Conditions
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Anal Cancer

Intervention / Treatment
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* Behavioral: Practice Self-/Companion Exams
* Behavioral: Control Arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly assigned to groups encouraged to practice anal examination (Experimental) or not encouraged to practice anal examinations (Control).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Practice Self-/Companion Exams<br>300 individuals and 50 couples will be randomized to practice arm. | Behavioral: Practice Self-/Companion Exams<br>* 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.<br>|
| Other: Control Arm<br>300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam. | Behavioral: Control Arm<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between self-examination and clinician examination | 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. | Day 1 | 
| Concordance between self-examination and clinician examination | 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. | Day 180. | 
| Concordance between companion examination and clinician examination | 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. | Day 1 | 
| Concordance between companion examination and clinician examination | 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. | Day 180 | 
| Number of persons who practice the self examination | This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 180. | Day 180 | 
| Number of persons who practice the companion examination | This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 180. | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the difference between Chicago and Houston self-exam concordance. | Differences in outcome measures 1-6, and 9 will be compared for subjects living in the Chicago and Houston metropolitan areas. | Day 1 | 
| 8. Measuring the difference between Chicago and Houston companion exam concordance. | Differences in outcome measures 1-6, and 9 will be compared for companions living in the Chicago and Houston metropolitan areas. | Day 1 | 
| Waist circumference for persons doing self-examinations | This measure will record subject waist circumference in cm and assess its association with OM 1 on Day 1. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anus neoplasm, Digital anal rectal examination, Self anal examination