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| ID | Type | Description | Link |
|---|---|---|---|
| UH2AA026214-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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According to the National HIV/AIDS Strategy, men who have sex with men (MSM), young adults, Black and Latino men and people in the Southern U.S. are at highest HIV risk and should be targeted with cost-effective, scalable interventions. The study team propose a synergistic mobile intervention to reduce alcohol and HIV risk in young adult MSM that combines 3 efficacious approaches.
New prevention efforts must address alcohol and HIV and be directed to the highest-risk groups. While interventions have targeted MSM, few have targeted young MSM specifically. Young people and MSM bring particular challenges. Thus, it is important that prevention be targeted to them and developed with their input. To that end, the goal of this project is to lay the groundwork for a synergistic, mobile intervention to reduce alcohol use and risky sex and prevent HIV among young adult MSM. This research study is made up of three related sub-projects: 1) a web-based survey; 2) a series of focus groups and 3) a small, preliminary acceptability and usability to study to test the mobile intervention. The proposed intervention to be tested on a preliminary basis in this study combines brief motivational intervention with daily interactive voice response (IVR) monitoring including personalized feedback. Ultimately, this combined intervention will also include pre-exposure prophylaxis (PrEP), however there will be no medication in this particular study. Each of these components has efficacy in enhancing treatment adherence, reducing alcohol and/or HIV risk but requires other interventions to maximize its potential benefit. Combining them will capitalize on the strength of each, leading to a higher impact alcohol and HIV preventive intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survey group | Active Comparator | Collect alcohol and sexual activity data via web survey from 683 young MSM to yield normative data for the alcohol and HIV preventive intervention in a follow-up study |
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| Focus Group | Active Comparator | 30 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. |
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| Usability Study | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of Alcohol Consumption | Determine levels of alcohol consumption in study population | Retrospective self-report over the past month |
| High-risk Sexual Behavior: Condomless Sex | Past month frequency of condomless sex | Retrospective self-report from past month on web survey |
| Study Participant Opinions on Acceptability of Intervention Content | 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. | Up to one month |
| Study Participant Opinions on Usability of Intervention Content | 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. | Up to 1 month |
| High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use | Past month frequency of alcohol use before or during oral, anal and/or vaginal sex | Past month on a self-report survey |
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Inclusion Criteria:
Web-survey:
Focus group:
Usability phase:
Exclusion Criteria:
Web Screen:
- No subject may have lifetime use of PrEP
Focus group:
Usability phase:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Leeman, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
Provision of insufficient data to be considered a valid participant
Participants who enrolled in a focus group/individual interview and the usability study were a subset of those who completed the survey
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| ID | Title | Description |
|---|---|---|
| FG000 | Young Adult Men Who Have Sex With Men | 18-30 young men who have sex with men |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Survey |
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| Focus Group/Individual Interview |
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| Usability Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Young Adult Men Who Have Sex With Men | 18-30 year old men who have sex with men residing in the Southern United States |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quantity of Alcohol Consumption | Determine levels of alcohol consumption in study population | Posted | Mean | Standard Deviation | drinks | Retrospective self-report over the past month |
|
1 month
Adverse event data were collected from usability study participants using the SAFTEE. Adverse events were not monitored in the survey or focus group/interviews. Surveys were completed via the web. Focus groups/interviews occurred within a single session of about an hour to an hour and a half in which participants answered questions, thus adverse events were not possible in these parts of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Leeman | Northeastern University | 6173736501 | r.leeman@northeastern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2019 | Apr 14, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2019 | Apr 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Focus Group | Other | 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. |
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| Usability study | Other | After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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.
| OG002 | Usability Study | 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. |
|
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| Primary | High-risk Sexual Behavior: Condomless Sex | Past month frequency of condomless sex | Posted | Mean | Standard Deviation | events | Retrospective self-report from past month on web survey |
|
|
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| Primary | Study Participant Opinions on Acceptability of Intervention Content | 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. | Acceptability was assessed only among participants in the usability study | Posted | Mean | Standard Deviation | score on a scale | Up to one month |
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|
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| Primary | Study Participant Opinions on Usability of Intervention Content | 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. | Acceptability and usability data were collected only from the usability study | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month |
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| Primary | High-risk Sexual Behavior: Sexual Activity During/After Alcohol Use | Past month frequency of alcohol use before or during oral, anal and/or vaginal sex | Posted | Mean | Standard Deviation | events | Past month on a self-report survey |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Usability Study | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |