Clinical trial · Interventional
The Prevent Anal Cancer Palpation Study
Determining the Accuracy of Self and Partner Anal Exams for Detecting Anal Abnormalities.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Arm | Behavioral | — | UNRESOLVED |
| Practice Self-/Companion Exams | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Practice Self-/Companion Exams
- description
- 300 individuals and 50 couples will be randomized to practice arm.
- interventionNames
- Behavioral: Practice Self-/Companion Exams
- type
- OTHER
- label
- Control Arm
- description
- 300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
- interventionNames
- Behavioral: Control Arm
Primary outcomes (6)
- measure
- Concordance Between Self-examination and Clinician Examination
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 25 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDNyitray 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. PMID 40018098
- DERIVEDNyitray 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. PMID 38352524