# Determining the accuracy of self- and partner anal exams for detecting anal abnormalities.

> **NIH NIH R01** · MEDICAL COLLEGE OF WISCONSIN · 2022 · $632,532

## Abstract

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. Our 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 self-anal exam
(SAE) or partner anal exam (PAE) 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 SAE and PAE 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 SAE and PAE 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 SAE and PAE sensitivity and specificity; 2)
Determine independent factors associated with SAE and PAE concordance; and 3) Determine the impact of
SAE, PAE, and DARE on survival and quality of life, and evaluate the cost-effectiveness of these strategies
among HIV+ and HIV- MSM. The aims will be accomplished with a study in Houston and Chicago with a
sample of 100 MSM couples (i.e., 200 partners) and 600 single MSM (two-thirds HIV-positive), aged 25-80
years, who will perform a clinician-taught SAE or PAE. The individual's SAE and partner's PAE will then be
compared with the clinician's DARE. The assessment will be done at each of two visits, spaced 12-months
apart, to assess retention of exam accuracy. The expected outcomes for aims 1 and 2 are sensitivity,
specificity and identification of clinical and behavioral factors associated with accuracy. Aim 3 outcomes will be
the computation of incremental cost-effectiveness ratios and net monetary benefits to assess the economic
viability of SAE, PAE, and DARE. This study is significant because it will demonstrate that a population with
substantial rates of anal disease can recognize when disease is present. The current application will provide
pivotal data that may challenge the status quo assumption that anal palpation must be performed by a
clinician. The proposed research also adds to ongoing research focused on detection of anal precancers given
the lack of proven efficacy for treatment of precancerous lesions, the lack of screening infrastructure for
detecting pr...

## Key facts

- **NIH application ID:** 10468124
- **Project number:** 5R01CA232892-05
- **Recipient organization:** MEDICAL COLLEGE OF WISCONSIN
- **Principal Investigator:** ALAN GASPAR NYITRAY
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $632,532
- **Award type:** 5
- **Project period:** 2018-09-17 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10468124

## Citation

> US National Institutes of Health, RePORTER application 10468124, Determining the accuracy of self- and partner anal exams for detecting anal abnormalities. (5R01CA232892-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10468124. Licensed CC0.

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