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The overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (MSM) who are seeking free HIV testing. Investigators will be conducting a randomized-controlled pilot test of the intervention among MSM seeking HIV testing in community-based settings to explore its potential impact on alcohol and HIV-related behavioral outcomes. This research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk MSM engage with prevention services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Attention-matched control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Electronic Intervention | Behavioral | The brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of New Sex Partners, Past 30 Days | Assessed via self-report using Timeline Follow Back (TLFB) | Past 30 days |
| Number of Condomless Anal Sex Events, Past 30 Days | Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events. | Past 30 days |
| Number of Drinking Days, Past 30 Days | Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30 | Past 30 days |
| Number of Heavy Drinking Days (5 or More), Past 30 Days | Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days. | Past 30 days |
| Average Number of Drinks Per Drinking Day | Assessed using Timeline Follow Back (TLFB) | Past 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University School of Public Health | Providence | Rhode Island | 02901 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Post-test Counseling (Control) | Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk. |
| FG001 | Brief Web-based Intervention | This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Brief Electronic Intervention: The brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so. |
| BG001 | Attention-matched Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of New Sex Partners, Past 30 Days | Assessed via self-report using Timeline Follow Back (TLFB) | Posted | Mean | Standard Deviation | New partners | Past 30 days |
|
3 months (the duration of the study period for all participants).
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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 | Standard Post-test Counseling (Control) | Participants will receive standard post-test counseling alone. This counseling consists of a one-on-one session with a Bachelor's level counselor and involves identifying personal risks for HIV, discussing options for reducing that risk, and eliciting commitment to a plan in order to reduce future risk. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tyler Wray | Brown University School of Public Health | 401-863-6659 | tyler_wray@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2017 | Jan 18, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2017 | Jan 18, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Randomized controlled trial where participants are assigned to either a treatment or control group.
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| Attention-Matched Control | Behavioral | Participants will view a video clip on general health promotion that is a similar length as the intervention arm. |
|
Attention-Matched Control: Participants will view a video clip on general health promotion that is a similar length as the intervention arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Condomless Anal Sex Events, Past 30 Days | Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events. | Posted | Mean | Standard Deviation | Events | Past 30 days |
|
|
|
| Primary | Number of Drinking Days, Past 30 Days | Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30 | Posted | Mean | Standard Deviation | Days | Past 30 days |
|
|
|
| Primary | Number of Heavy Drinking Days (5 or More), Past 30 Days | Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days. | Posted | Mean | Standard Deviation | Days | Past 30 days |
|
|
|
| Primary | Average Number of Drinks Per Drinking Day | Assessed using Timeline Follow Back (TLFB) | Posted | Mean | Standard Deviation | Drinks | Past 30 days |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Brief Web-based Intervention | This web-based intervention will be delivered on a tablet, and will involve presenting feedback on HIV risk behavior and alcohol use, normative comparisons with other gay/bi men in their age group, exercises designed to help them reflect on whether or not they want to make a change, and change planning modules to help users select an option that works for them and get them started. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |