Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04090060 |
| Other study ID # |
PRO00033000 |
| Secondary ID |
R01CA232892-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 17, 2020 |
| Est. completion date |
June 10, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Medical College of Wisconsin |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 HCP exam. Regardless of prior results, all
persons will be asked to return for Visit 2.
