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.