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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA232892-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Chicago | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| Gordon Crofoot MD PA |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Practice Self-/Companion Exams | Experimental | 300 individuals and 50 couples will be randomized to practice arm. |
|
| Control Arm | Other | 300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Practice Self-/Companion Exams | Behavioral | 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring the Difference Between Chicago and Houston Self-exam Concordance. | 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. | Day 1 |
| Measuring the Difference Between Chicago and Houston Companion Exam Concordance. |
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Inclusion Criteria:
Exclusion Criteria:
Cis-gendered men and transgender persons.
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| Name | Affiliation | Role |
|---|---|---|
| Alan Nyitray, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| Medical University of South Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40018098 | Derived | Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa L, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: an observational study. BMJ Public Health. 2024 Jul 12;2(1):e001039. doi: 10.1136/bmjph-2024-001039. eCollection 2024 Jun. | |
| 38352524 | Derived |
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After consenting online, individuals must have attended a visit 1 where the intervention was delivered and followed by randomization into Practice or Control arms. The stated number of enrollees, 718, represents unique individuals who attended visit 1 and received the intervention regardless of the individual choosing to participate in the intervention as a single person or with a partner. The outcomes are assessed at the individual level and not couple level.
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| ID | Title | Description |
|---|---|---|
| FG000 | Practice Self-/Companion Exams | 300 individuals and 50 couples will be randomized to practice arm. 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. Thus the Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads. |
| FG001 | Control Arm | 300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam. 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. The Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Practice Self-/Companion Exams | 300 individuals and 50 couples will be randomized to practice arm. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of 718 individuals, outcome results were available for 714 individuals with two participants in the Practice Self/Companion Exams arm and two participants in the Control Arm not completing the self-/companion examination or not completing a digital anal rectal examination. Of the 714, 357 were in the practice arm and 357 in the control arm. Of the 714, 658 completed a self-exam and 56 completed a companion exam. | Posted | Count of Participants | Participants | Day 1 |
|
180 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Practice Self-/Companion Exams | 300 individuals and 50 couples will be randomized to practice arm. 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Nyitray, PhD | Medical college of Wisconsin | 414-955-7701 | anyitray@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2023 | Jun 6, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 15, 2022 | Jan 31, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| UNKNOWN |
| National Cancer Institute (NCI) | NIH |
Subjects will be randomly assigned to groups encouraged to practice anal examination (Experimental) or not encouraged to practice anal examinations (Control).
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| Control Arm | Behavioral | 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. |
|
| Day 180 |
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. |
| Day 1 |
| Waist Circumference for Persons Doing Self-examinations | This measure will record subject waist circumference in cm. | Day 1 |
| Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference. | 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. | Day 1 |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Gordon Crofoot MD | Houston | Texas | 77098 | United States |
| Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa LR, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: An observational study. medRxiv [Preprint]. 2024 Feb 1:2024.01.31.24302098. doi: 10.1101/2024.01.31.24302098. |
| BG001 | Control Arm | 300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Arm | 300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam. 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. |
|
|
| Primary | 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. | Seventy of 331 participants in the Practice Self-Companion Exams arm and 72 of 327 participants in the control arm completing a baseline examination (Outcome Measure 1) did not complete an examination at 180 days. | Posted | Count of Participants | Participants | Day 180. |
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|
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| Primary | 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. | The unit of analysis is the individual and not the couple. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | 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. | Twenty of twenty-six participants in the Practice Self-/Companion Exams arm and twenty-six of thirty participants in the Control Arm completed companion examinations at 180 days. | Posted | Count of Participants | Participants | Day 180 |
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|
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| Primary | 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. | All units of data are unique individuals and not couples. | Posted | Count of Participants | Participants | Day 180 |
|
|
|
| Primary | 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. | The unit of analysis is the individual not the dyad (or couple). | Posted | Count of Participants | Participants | Day 180 |
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| Secondary | Measuring the Difference Between Chicago and Houston Self-exam Concordance. | 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. | This measure involves only the participants living in either the Chicago or Houston metropolitan areas. | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Measuring the Difference Between Chicago and Houston Companion Exam Concordance. | 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. | This measure involves only the participants living in either the Chicago or Houston metropolitan areas who conducted companion examinations. | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Waist Circumference for Persons Doing Self-examinations | This measure will record subject waist circumference in cm. | Waist circumference was not measured for 2 individuals in the practice arm and 2 individuals in the control arm. | Posted | Median | Full Range | centimeter | Day 1 |
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| Secondary | Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference. | 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. | This measure involves only the participants who performed a self-examination and whose waste circumference was measured. Two participants in each arm were missing waist circumference. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 359 |
| 0 |
| 359 |
| 0 |
| 359 |
| EG001 | Control Arm | 300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam. 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. | 0 | 359 | 0 | 359 | 0 | 359 |
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| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| Houston |
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| Houston |
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| Circumference >102 cm |
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