Trial Outcomes & Findings for The Prevent Anal Cancer Palpation Study (NCT NCT04090060)
NCT ID: NCT04090060
Last Updated: 2024-07-09
Results Overview
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
718 participants
Primary outcome timeframe
Day 1
Results posted on
2024-07-09
Participant Flow
After consenting online, individuals must have attended a visit 1 where the intervention was delivered and followed by randomization into Practice or Control arms. The stated number of enrollees, 718, represents unique individuals who attended visit 1 and received the intervention regardless of the individual choosing to participate in the intervention as a single person or with a partner. The outcomes are assessed at the individual level and not couple level.
Participant milestones
| Measure |
Practice Self-/Companion Exams
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
Thus the Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads.
|
Control Arm
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
The Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads.
|
|---|---|---|
|
Overall Study
STARTED
|
359
|
359
|
|
Overall Study
COMPLETED
|
283
|
282
|
|
Overall Study
NOT COMPLETED
|
76
|
77
|
Reasons for withdrawal
| Measure |
Practice Self-/Companion Exams
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
Thus the Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads.
|
Control Arm
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
The Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
76
|
77
|
Baseline Characteristics
The Prevent Anal Cancer Palpation Study
Baseline characteristics by cohort
| Measure |
Practice Self-/Companion Exams
n=359 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=359 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
Total
n=718 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
340 Participants
n=5 Participants
|
342 Participants
n=7 Participants
|
682 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
337 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
675 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans Man
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans Woman
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
92 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
266 Participants
n=5 Participants
|
286 Participants
n=7 Participants
|
552 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
88 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
217 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
429 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
359 participants
n=5 Participants
|
359 participants
n=7 Participants
|
718 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Of 718 individuals, outcome results were available for 714 individuals with two participants in the Practice Self/Companion Exams arm and two participants in the Control Arm not completing the self-/companion examination or not completing a digital anal rectal examination. Of the 714, 357 were in the practice arm and 357 in the control arm. Of the 714, 658 completed a self-exam and 56 completed a companion exam.
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=331 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=327 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Concordance Between Self-examination and Clinician Examination
|
234 Participants
|
247 Participants
|
PRIMARY outcome
Timeframe: Day 180.Population: Seventy of 331 participants in the Practice Self-Companion Exams arm and 72 of 327 participants in the control arm completing a baseline examination (Outcome Measure 1) did not complete an examination at 180 days.
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=261 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=255 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Concordance Between Self-examination and Clinician Examination
|
248 Participants
|
246 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The unit of analysis is the individual and not the couple.
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=26 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=30 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Concordance Between Companion Examination and Clinician Examination
|
20 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Day 180Population: Twenty of twenty-six participants in the Practice Self-/Companion Exams arm and twenty-six of thirty participants in the Control Arm completed companion examinations at 180 days.
This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=20 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=26 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Concordance Between Companion Examination and Clinician Examination
|
19 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Day 180Population: All units of data are unique individuals and not couples.
This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 180.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=331 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=327 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Number of Persons Who Practice the Self Examination
|
261 Participants
|
255 Participants
|
PRIMARY outcome
Timeframe: Day 180Population: The unit of analysis is the individual not the dyad (or couple).
This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 180.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=26 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=30 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Number of Persons Who Practice the Companion Examination
|
20 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: This measure involves only the participants living in either the Chicago or Houston metropolitan areas.
This measure will count the number of subjects in outcome measures 1, 2, 5 and 9 comparing subjects living in the Chicago and Houston metropolitan areas.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=331 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=327 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Measuring the Difference Between Chicago and Houston Self-exam Concordance.
Chicago
|
127 Participants
|
139 Participants
|
|
Measuring the Difference Between Chicago and Houston Self-exam Concordance.
Houston
|
107 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: This measure involves only the participants living in either the Chicago or Houston metropolitan areas who conducted companion examinations.
This measure will count the number of subjects in outcome measures 3, 4, 6 and 9 comparing companions living in the Chicago and Houston metropolitan areas.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=26 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=30 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Measuring the Difference Between Chicago and Houston Companion Exam Concordance.
Chicago
|
10 Participants
|
6 Participants
|
|
Measuring the Difference Between Chicago and Houston Companion Exam Concordance.
Houston
|
10 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Waist circumference was not measured for 2 individuals in the practice arm and 2 individuals in the control arm.
This measure will record subject waist circumference in cm.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=329 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=325 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Waist Circumference for Persons Doing Self-examinations
|
96.1 centimeter
Interval 66.0 to 171.2
|
95.3 centimeter
Interval 66.6 to 178.0
|
SECONDARY outcome
Timeframe: Day 1Population: This measure involves only the participants who performed a self-examination and whose waste circumference was measured. Two participants in each arm were missing waist circumference.
This measure will record the number of concordant digital anal examination results in persons with less than or equal to 102 cm waist size versus greater than 102 cm waist size. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.
Outcome measures
| Measure |
Practice Self-/Companion Exams
n=329 Participants
300 individuals and 50 couples will be randomized to practice arm.
Practice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
|
Control Arm
n=325 Participants
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Control Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
|
|---|---|---|
|
Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference.
Circumference >102 cm
|
79 Participants
|
71 Participants
|
|
Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference.
Circumference <= 102 cm
|
153 Participants
|
174 Participants
|
Adverse Events
Practice Self-/Companion Exams
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place