The Prevent Anal Cancer Palpation Study
Study Details
Study Description
Brief Summary
Anal cancer is a common cancer among gay, bisexual and other men having sex with men (MSM). Its annual incidence is approximately 50-fold and 5-fold higher among HIV-positive MSM and HIV-negative MSM, respectively, compared to the rest of the general population. Like cervical cancer, it is primarily caused by human papillomaviruses (HPV). Unlike cervical cancer, there is no efficacious treatment for anal precancers as there is for cervical precancers. To date, randomized clinical trials have failed to find an efficacious treatment although other trials continue; thus, professional societies recommend an annual digital ano-rectal exam (DARE) for detection of anal abnormalities, including small tumors, among all MSM. But DARE is underutilized, e.g., most persons, regardless of HIV do not receive an annual DARE and most HIV physicians do not perform the exam. Therefore, alternative methods for early detection are needed because early detection of small tumors is associated with >85% 5-year survival.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 HCP exam. Regardless of prior results, all persons will be asked to return for Visit 2.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Practice Self-/Companion Exams 300 individuals and 50 couples will be randomized to practice arm. |
Behavioral: Practice Self-/Companion Exams
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.
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| Other: Control Arm 300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam. |
Behavioral: Control Arm
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.
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Outcome Measures
Primary Outcome Measures
- Concordance between self-examination and clinician examination [Day 1]
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.
- 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.
- Concordance between companion examination and clinician examination [Day 1]
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.
- 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 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.
- 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
- Measuring the difference between Chicago and Houston self-exam concordance. [Day 1]
Differences in outcome measures 1-6, 9 and 10 will be compared for subjects living in the Chicago and Houston metropolitan areas.
- Measuring the difference between Chicago and Houston companion exam concordance. [Day 1]
Differences in outcome measures 1-6, 9 and 10 will be compared for 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 and assess its association with OM 1 on Day 1.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chicago or Houston Metro Residents
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Persons who had sex with men in the prior five years
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Cis-gendered men and transgender persons
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Age: 25 years and over
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Access to medical care for referral or treatment
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Spanish or English speakers/readers
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Individuals or couples
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HIV+ or HIV-
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Persons with or without comorbidities and physical disabilities
Exclusion Criteria:
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Unresolved health care provider's diagnosis of anal condyloma, hemorrhoids or anal cancer
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DARE in the prior three months
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Plans to move in the following six months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 2 | M.D. Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 3 | University of Texas Health Sciences Center | Houston | Texas | United States | 77030 |
| 4 | Gordon Crofoot MD | Houston | Texas | United States | 77098 |
Sponsors and Collaborators
- Medical College of Wisconsin
- University of Chicago
- M.D. Anderson Cancer Center
- The University of Texas Health Science Center, Houston
- Gordon Crofoot MD PA
Investigators
- Principal Investigator: Alan Nyitray, PhD, Medical College of Wisconsin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO00033000