Trial Outcomes & Findings for ANCHORS Study: UH2 Project (NCT NCT03360422)
NCT ID: NCT03360422
Last Updated: 2024-07-11
Results Overview
Determine levels of alcohol consumption in study population
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
673 participants
Primary outcome timeframe
Retrospective self-report over the past month
Results posted on
2024-07-11
Participant Flow
Participants who enrolled in a focus group/individual interview and the usability study were a subset of those who completed the survey
Provision of insufficient data to be considered a valid participant
Participant milestones
| Measure |
Young Adult Men Who Have Sex With Men
18-30 young men who have sex with men
|
|---|---|
|
Survey
STARTED
|
673
|
|
Survey
COMPLETED
|
673
|
|
Survey
NOT COMPLETED
|
0
|
|
Focus Group/Individual Interview
STARTED
|
24
|
|
Focus Group/Individual Interview
COMPLETED
|
24
|
|
Focus Group/Individual Interview
NOT COMPLETED
|
0
|
|
Usability Study
STARTED
|
10
|
|
Usability Study
COMPLETED
|
10
|
|
Usability Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ANCHORS Study: UH2 Project
Baseline characteristics by cohort
| Measure |
Young Adult Men Who Have Sex With Men
n=673 Participants
18-30 year old men who have sex with men residing in the Southern United States
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
673 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.77 years
STANDARD_DEVIATION 3.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
673 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
509 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
117 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
458 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
673 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Retrospective self-report over the past monthDetermine levels of alcohol consumption in study population
Outcome measures
| Measure |
Survey Group
n=673 Participants
Collect alcohol and sexual activity data via web survey from 673 young MSM to yield normative data for the alcohol and HIV preventive intervention in a follow-up study
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
|
Focus Group/Individual Interview
n=24 Participants
24 young MSM who drink regularly to inform the content of the alcohol and HIV preventive intervention tested in the UH3 phase and ensure the intervention is culturally appropriate for MSM.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Focus Group: After informed consent, participants will complete the web-based intervention component in development. Afterward, participants will be engaged by an experienced facilitator in a discussion of aspects of the intervention they liked and disliked and suggestions they have for enhancing its cultural appropriateness to young MSM.
|
Usability Study
n=10 Participants
10 young adult MSM will test the mobile intervention in development for 30 days in order to establish usability, acceptability and correct any functionality issues.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Usability study: After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.
|
|---|---|---|---|
|
Quantity of Alcohol Consumption
|
11.38 drinks
Standard Deviation 20.05
|
7.81 drinks
Standard Deviation 7.80
|
4.78 drinks
Standard Deviation 2.78
|
PRIMARY outcome
Timeframe: Retrospective self-report from past month on web surveyPast month frequency of condomless sex
Outcome measures
| Measure |
Survey Group
n=673 Participants
Collect alcohol and sexual activity data via web survey from 673 young MSM to yield normative data for the alcohol and HIV preventive intervention in a follow-up study
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
|
Focus Group/Individual Interview
n=24 Participants
24 young MSM who drink regularly to inform the content of the alcohol and HIV preventive intervention tested in the UH3 phase and ensure the intervention is culturally appropriate for MSM.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Focus Group: After informed consent, participants will complete the web-based intervention component in development. Afterward, participants will be engaged by an experienced facilitator in a discussion of aspects of the intervention they liked and disliked and suggestions they have for enhancing its cultural appropriateness to young MSM.
|
Usability Study
n=10 Participants
10 young adult MSM will test the mobile intervention in development for 30 days in order to establish usability, acceptability and correct any functionality issues.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Usability study: After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.
|
|---|---|---|---|
|
High-risk Sexual Behavior: Condomless Sex
|
4.12 events
Standard Deviation 6.92
|
2.22 events
Standard Deviation 3.23
|
7.17 events
Standard Deviation 9.39
|
PRIMARY outcome
Timeframe: Up to one monthPopulation: Acceptability was assessed only among participants in the usability study
Participants in the usability study will report on the acceptability of the interactive voice response (IVR) system and the personalized feedback produced based on their IVR responses. On a modified System Usability Scale, participants in the usability study will report on the acceptability (i.e., perceived value, liking) of the interactive voice response (IVR) system and the personalized feedback produced based on their IVR responses. Items were rated on a 1-7 scale with higher scores indicating greater usability. The acceptability subscale is made up of 5 items. The score reported below is the mean of these five items.
Outcome measures
| Measure |
Survey Group
Collect alcohol and sexual activity data via web survey from 673 young MSM to yield normative data for the alcohol and HIV preventive intervention in a follow-up study
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
|
Focus Group/Individual Interview
24 young MSM who drink regularly to inform the content of the alcohol and HIV preventive intervention tested in the UH3 phase and ensure the intervention is culturally appropriate for MSM.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Focus Group: After informed consent, participants will complete the web-based intervention component in development. Afterward, participants will be engaged by an experienced facilitator in a discussion of aspects of the intervention they liked and disliked and suggestions they have for enhancing its cultural appropriateness to young MSM.
|
Usability Study
n=10 Participants
10 young adult MSM will test the mobile intervention in development for 30 days in order to establish usability, acceptability and correct any functionality issues.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Usability study: After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.
|
|---|---|---|---|
|
Study Participant Opinions on Acceptability of Intervention Content
|
—
|
—
|
5.50 score on a scale
Standard Deviation 1.51
|
PRIMARY outcome
Timeframe: Up to 1 monthPopulation: Acceptability and usability data were collected only from the usability study
On a modified System Usability Scale, participants in the usability study will report on the usability of the interactive voice response (IVR) system and the personalized feedback produced based on their IVR responses. Items were rated on a 1-7 scale with higher scores indicating greater usability. The usability subscale is made up of 4 items. The score reported below is the mean of these four items.
Outcome measures
| Measure |
Survey Group
Collect alcohol and sexual activity data via web survey from 673 young MSM to yield normative data for the alcohol and HIV preventive intervention in a follow-up study
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
|
Focus Group/Individual Interview
24 young MSM who drink regularly to inform the content of the alcohol and HIV preventive intervention tested in the UH3 phase and ensure the intervention is culturally appropriate for MSM.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Focus Group: After informed consent, participants will complete the web-based intervention component in development. Afterward, participants will be engaged by an experienced facilitator in a discussion of aspects of the intervention they liked and disliked and suggestions they have for enhancing its cultural appropriateness to young MSM.
|
Usability Study
n=10 Participants
10 young adult MSM will test the mobile intervention in development for 30 days in order to establish usability, acceptability and correct any functionality issues.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Usability study: After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.
|
|---|---|---|---|
|
Study Participant Opinions on Usability of Intervention Content
|
—
|
—
|
6.40 score on a scale
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: Past month on a self-report surveyPast month frequency of alcohol use before or during oral, anal and/or vaginal sex
Outcome measures
| Measure |
Survey Group
n=673 Participants
Collect alcohol and sexual activity data via web survey from 673 young MSM to yield normative data for the alcohol and HIV preventive intervention in a follow-up study
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
|
Focus Group/Individual Interview
n=24 Participants
24 young MSM who drink regularly to inform the content of the alcohol and HIV preventive intervention tested in the UH3 phase and ensure the intervention is culturally appropriate for MSM.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Focus Group: After informed consent, participants will complete the web-based intervention component in development. Afterward, participants will be engaged by an experienced facilitator in a discussion of aspects of the intervention they liked and disliked and suggestions they have for enhancing its cultural appropriateness to young MSM.
|
Usability Study
n=10 Participants
10 young adult MSM will test the mobile intervention in development for 30 days in order to establish usability, acceptability and correct any functionality issues.
Survey: Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
Usability study: After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.
|
|---|---|---|---|
|
High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use
|
2.88 events
Standard Deviation 5.16
|
2.13 events
Standard Deviation 3.49
|
1.50 events
Standard Deviation 1.05
|
Adverse Events
Survey Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Focus Group/Individual Interview
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usability Study
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