N/A
N=718
The Prevent Anal Cancer Palpation Study
Anal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04090060 ↗Enrolled (actual)
718
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Concordance Between Self-examination and Clinician Examination — 234; 247 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Practice Self-/Companion Exams (Behavioral); Control Arm (Behavioral)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Male
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concordance Between Self-examination and Clinician Examination |
248; 246 | — |
| PRIMARY Concordance Between Self-examination and Clinician Examination |
248; 246 | — |
| PRIMARY Concordance Between Companion Examination and Clinician Examination |
19; 23 | — |
| PRIMARY Concordance Between Companion Examination and Clinician Examination |
19; 23 | — |
| PRIMARY Number of Persons Who Practice the Self Examination |
261; 255 | — |
| PRIMARY Number of Persons Who Practice the Companion Examination |
20; 26 | — |
| SECONDARY Measuring the Difference Between Chicago and Houston Self-exam Concordance. |
127; 139; 107; 108 | — |
| SECONDARY Measuring the Difference Between Chicago and Houston Companion Exam Concordance. |
10; 6; 10; 16 | — |
| SECONDARY Waist Circumference for Persons Doing Self-examinations |
96.1; 95.3 | — |
| SECONDARY Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference. |
153; 174; 79; 71 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04090060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.