Hazardous Drinking, HIV
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBrief 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
Sponsors
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be at least 18 years of age * drink heavily at least once per month on average (≥5 drinks) or drink more than 14 drinks per week * have a confirmed diagnosis of HIV/AIDS * be a male who has had sex (oral or anal) with a male partner in the past 3 months.
Exclusion criteria
* current intravenous drug use * currently psychotic, suicidal, or manic * are currently being treated or have been treated in the past 3 months for an HIV-related opportunistic infection * currently receiving treatment for an alcohol or drug problem
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Alcoholic Drinks Consumed | 12 months | Number of standard alcoholic drinks consumed per week in the past month |
| Number of Heavy Drinking Days | 12 months | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 91 |
| 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 | 89 |
| Total | 180 |
Baseline characteristics
| Characteristic | Treatment as Usual | Total | Brief Alcohol Intervention |
|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 10.5 | 42.1 years STANDARD_DEVIATION 10.4 | 41.0 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 31 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 149 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 35 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 64 Participants | 134 Participants | 70 Participants |
| Region of Enrollment United States | 91 Participants | 180 Participants | 89 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 91 Participants | 180 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 89 |
| other Total, other adverse events | 0 / 91 | 0 / 89 |
| serious Total, serious adverse events | 0 / 91 | 0 / 89 |
Outcome results
Primary
Number of Alcoholic Drinks Consumed
Number of standard alcoholic drinks consumed per week in the past month
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment as Usual | Number of Alcoholic Drinks Consumed | 11.6 drinks per week |
| Brief Alcohol Intervention | Number of Alcoholic Drinks Consumed | 7.2 drinks per week |
p-value: 0.04t-test, 2 sided
Primary
Number of Alcoholic Drinks Consumed
Number of standard alcoholic drinks consumed per week in the past month
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment as Usual | Number of Alcoholic Drinks Consumed | 14.4 drinks per week |
| Brief Alcohol Intervention | Number of Alcoholic Drinks Consumed | 11.9 drinks per week |
p-value: 0.25t-test, 2 sided
Primary
Number of Alcoholic Drinks Consumed
Number of standard alcoholic drinks consumed per week in the past month
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment as Usual | Number of Alcoholic Drinks Consumed | 14.5 drinks per week |
| Brief Alcohol Intervention | Number of Alcoholic Drinks Consumed | 8.0 drinks per week |
p-value: <0.001t-test, 2 sided
Primary
Number of Heavy Drinking Days
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment as Usual | Number of Heavy Drinking Days | 3 Days |
| Brief Alcohol Intervention | Number of Heavy Drinking Days | 1 Days |
p-value: <0.01Wilcoxon (Mann-Whitney)
Primary
Number of Heavy Drinking Days
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment as Usual | Number of Heavy Drinking Days | 4 Days |
| Brief Alcohol Intervention | Number of Heavy Drinking Days | 2 Days |
p-value: <0.01Wilcoxon (Mann-Whitney)
Primary
Number of Heavy Drinking Days
Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment as Usual | Number of Heavy Drinking Days | 4 Days |
| Brief Alcohol Intervention | Number of Heavy Drinking Days | 3 Days |
p-value: 0.48Wilcoxon (Mann-Whitney)