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This is a randomized clinical trial to examine the effects of a brief counseling intervention for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. The study tests the hypothesis that brief counseling will lower drinking in these patients and that reductions in drinking will be associated with better HIV-related outcomes.
This study is a randomized clinical trial in which 224 heavy drinking men who have sex with men (MSM), who receive their HIV primary care at Fenway Health in Boston, are randomly assigned to treatment as usual (TAU) or TAU plus a brief intervention to reduce alcohol use (TAU-BI). TAU-BI will be based in Motivational Interviewing and include personalized feedback tailored to an HIV-infected MSM population. Follow-ups will occur at 3, 6, and 12 months. The first primary aim of the study is to test the hypothesis that TAU-BI, compared to TAU, will result in reduced alcohol consumption over a 12-month follow-up period as indicated by: (1) a lower number of alcoholic drinks consumed per week; (2) a lower number of drinking days within each follow-up period; and (3) a lower number of heavy drinking days within each follow-up period. The second primary aim is to test the hypothesis that greater reductions in alcohol use will be associated with (1) greater adherence to HIV medication regimens; (2) less engagement in high-risk sexual behavior that could result in HIV transmission; (3) lower plasma HIV RNA levels (viral load) (CD4 cell counts will be a secondary outcome in this sub-aim); (4) improved liver function tests; and (5) improved neurocognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | No Intervention | Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking. | |
| Brief Alcohol Intervention | Experimental | Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief alcohol intervention | Behavioral | 3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Alcoholic Drinks Consumed | Number of standard alcoholic drinks consumed per week in the past month | 12 months |
| Number of Heavy Drinking Days | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month | 12 months |
| Number of Heavy Drinking Days | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month | 6 months |
| Number of Heavy Drinking Days | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month | 3 months |
| Number of Alcoholic Drinks Consumed | Number of standard alcoholic drinks consumed per week in the past month | 3 months |
| Number of Alcoholic Drinks Consumed | Number of standard alcoholic drinks consumed per week in the past month | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Monti, Ph.D. | Brown University | Principal Investigator |
| Christopher Kahler, Ph.D. | Brown University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenway Health | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35687187 | Derived | Zelaya DG, Guy AA, Surace A, Mastroleo NR, Pantalone DW, Monti PM, Mayer KH, Kahler CW. Modeling the Impact of Race, Socioeconomic Status, Discrimination and Cognitive Appraisal on Mental Health Concerns Among Heavy Drinking HIV+ Cisgender MSM. AIDS Behav. 2022 Dec;26(12):3925-3938. doi: 10.1007/s10461-022-03719-0. Epub 2022 Jun 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual | Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking. |
| FG001 | Brief Alcohol Intervention | Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls Brief alcohol intervention: 3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual | Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking. |
| BG001 | Brief Alcohol Intervention |
| 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 Alcoholic Drinks Consumed | Number of standard alcoholic drinks consumed per week in the past month | Posted | Median | Inter-Quartile Range | drinks per week | 12 months |
|
1 Year
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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 | Treatment as Usual | Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kahler | Brown University | 4018636651 | christopher_kahler@brown.edu |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D008722 | Methods |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008919 | Investigative Techniques |
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Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls
Brief alcohol intervention: 3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking
| BG002 | Total | Total of all reporting groups |
| 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 | Count of Participants | Participants |
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| Primary | Number of Heavy Drinking Days | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month | Posted | Median | Inter-Quartile Range | Days | 12 months |
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| Primary | Number of Heavy Drinking Days | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month | Posted | Median | Inter-Quartile Range | Days | 6 months |
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| Primary | Number of Heavy Drinking Days | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month | Posted | Median | Inter-Quartile Range | Days | 3 months |
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| Primary | Number of Alcoholic Drinks Consumed | Number of standard alcoholic drinks consumed per week in the past month | Posted | Median | Inter-Quartile Range | drinks per week | 3 months |
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| Primary | Number of Alcoholic Drinks Consumed | Number of standard alcoholic drinks consumed per week in the past month | Posted | Median | Inter-Quartile Range | drinks per week | 6 months |
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| 0 |
| 91 |
| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | Brief Alcohol Intervention | Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls Brief alcohol intervention: 3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking | 0 | 89 | 0 | 89 | 0 | 89 |
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