The Prevent Anal Cancer Palpation Study

Not Applicable

Completed

Conditions: Anal Cancer

Interventions: Behavioral: Practice Self-/Companion Exams
Behavioral: Control Arm

Registration Number: NCT04090060

Lead Sponsor: Medical College of Wisconsin

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 718

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Practice Self-/Companion Exams	Practice Self-/Companion Exams	300 individuals and 50 couples will be randomized to practice arm.
Control Arm	Control Arm	300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.

Primary Outcome Measures

Name	Time	Method
Concordance Between Self-examination and Clinician Examination	Day 180.	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.
Number of Persons Who Practice the Self Examination	Day 180	This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 180.
Concordance Between Companion Examination and Clinician Examination	Day 180	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.
Number of Persons Who Practice the Companion Examination	Day 180	This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 180.

Secondary Outcome Measures

Name	Time	Method
Measuring the Difference Between Chicago and Houston Self-exam Concordance.	Day 1	This measure will count the number of subjects in outcome measures 1, 2, 5 and 9 comparing subjects living in the Chicago and Houston metropolitan areas.
Measuring the Difference Between Chicago and Houston Companion Exam Concordance.	Day 1	This measure will count the number of subjects in outcome measures 3, 4, 6 and 9 comparing companions living in the Chicago and Houston metropolitan areas.
Waist Circumference for Persons Doing Self-examinations	Day 1	This measure will record subject waist circumference in cm.
Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference.	Day 1	This measure will record the number of concordant digital anal examination results in persons with less than or equal to 102 cm waist size versus greater than 102 cm waist size. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.

Trial Locations

Locations (4): 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