Trial Outcomes & Findings for Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting (NCT NCT01328743)

NCT ID: NCT01328743

Last Updated: 2019-09-09

Results Overview

Number of standard alcoholic drinks consumed per week in the past month

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 180 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-09-09

Participant Flow

Participant milestones

Measure	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.	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
Overall Study STARTED	91	89
Overall Study COMPLETED	82	79
Overall Study NOT COMPLETED	9	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting

Baseline characteristics by cohort

Measure	Treatment as Usual n=91 Participants 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 n=89 Participants 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	Total n=180 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 10.5 • n=5 Participants	41.0 years STANDARD_DEVIATION 10.3 • n=7 Participants	42.1 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	89 Participants n=7 Participants	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants	73 Participants n=7 Participants	149 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	70 Participants n=7 Participants	134 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	91 Participants n=5 Participants	89 Participants n=7 Participants	180 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Number of standard alcoholic drinks consumed per week in the past month

Outcome measures

Measure	Treatment as Usual n=82 Participants 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 n=79 Participants 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
Number of Alcoholic Drinks Consumed	11.6 drinks per week Interval 4.2 to 21.5	7.2 drinks per week Interval 2.3 to 12.6

PRIMARY outcome

Timeframe: 12 months

Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month

Outcome measures

Measure	Treatment as Usual n=82 Participants 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 n=79 Participants 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
Number of Heavy Drinking Days	3 Days Interval 1.0 to 6.0	1 Days Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: 6 months

Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month

Outcome measures

Measure	Treatment as Usual n=86 Participants 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 n=78 Participants 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
Number of Heavy Drinking Days	4 Days Interval 1.0 to 9.0	2 Days Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 3 months

Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month

Outcome measures

Measure	Treatment as Usual n=88 Participants 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 n=79 Participants 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
Number of Heavy Drinking Days	4 Days Interval 1.0 to 9.0	3 Days Interval 1.0 to 8.0

PRIMARY outcome

Timeframe: 3 months

Number of standard alcoholic drinks consumed per week in the past month

Outcome measures

Measure	Treatment as Usual n=88 Participants 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 n=79 Participants 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
Number of Alcoholic Drinks Consumed	14.4 drinks per week Interval 7.6 to 27.3	11.9 drinks per week Interval 6.5 to 19.6

PRIMARY outcome

Timeframe: 6 months

Number of standard alcoholic drinks consumed per week in the past month

Outcome measures

Measure	Treatment as Usual n=86 Participants 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 n=78 Participants 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
Number of Alcoholic Drinks Consumed	14.5 drinks per week Interval 4.7 to 26.4	8.0 drinks per week Interval 4.2 to 12.8

Adverse Events

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brief Alcohol Intervention

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

Christopher Kahler

Brown University

Phone: 4018636651

Email: christopher_kahler@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place