Trial Outcomes & Findings for Alcohol Research Consortium in HIV-Intervention Research Arm (NCT NCT02938377)

Results Overview

Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

4985 participants

Primary outcome timeframe

18 month window

Results posted on

2025-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Risky Drinking, no dx of AUD, Has Panic or Depression Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace	Dx of AUD With or Without Panic or Depression Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol. Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace Recommendation and Counseling for Alcohol Pharmacotherapy: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care.	No dx of Alcohol Use Disorder, Panic or Depression This arm received standard of care services at each clinic.
Overall Study STARTED	115	27	4843
Overall Study COMPLETED	115	27	4843
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alcohol Research Consortium in HIV-Intervention Research Arm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risky Drinking, no dx of AUD, Has Panic or Depression n=115 Participants Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace	Dx of AUD With or Without Panic or Depression n=27 Participants Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol. Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace Recommendation and Counseling for Alcohol Pharmacotherapy: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care.	No dx of Alcohol Use Disorder, Panic or Depression n=4843 Participants This arm will receive standard of care services at each clinic.	Total n=4985 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 12 • n=5 Participants	45 years STANDARD_DEVIATION 11 • n=7 Participants	49 years STANDARD_DEVIATION 12 • n=5 Participants	47 years STANDARD_DEVIATION 12 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	3 Participants n=7 Participants	969 Participants n=5 Participants	994 Participants n=4 Participants
Sex: Female, Male Male	93 Participants n=5 Participants	24 Participants n=7 Participants	3874 Participants n=5 Participants	3991 Participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic White	45 Participants n=5 Participants	9 Participants n=7 Participants	1839 Participants n=5 Participants	1893 Participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic Black	55 Participants n=5 Participants	8 Participants n=7 Participants	2151 Participants n=5 Participants	2214 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	11 Participants n=5 Participants	9 Participants n=7 Participants	649 Participants n=5 Participants	669 Participants n=4 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	1 Participants n=7 Participants	204 Participants n=5 Participants	209 Participants n=4 Participants

PRIMARY outcome

Timeframe: 18 month window

Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.

Outcome measures

Outcome measures
Measure	Risky Drinking, no dx of AUD, Has Panic or Depression n=115 Participants Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace	Dx of AUD With or Without Panic or Depression n=27 Participants Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol. Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace Recommendation and Counseling for Alcohol Pharmacotherapy: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care.	No dx of Alcohol Use Disorder, Panic or Depression n=4843 Participants This arm will receive standard of care services at each clinic.
Audit-C Score on a Scale	-1.0 score on a scale Interval -1.3 to -0.6	-2.3 score on a scale Interval -3.5 to -1.0	-1.0 score on a scale Interval -1.4 to -0.5

SECONDARY outcome

Timeframe: Between baseline and 6 month follow-up

Population: As a result of the COVID pandemic, sample collection was disrupted, leading to only 13 samples collected overall. This number of samples was below the 75% threshold needed to justify processing the samples. Samples were never sent for PeTH testing and will not be sent for PeTH testing.

PEth is a biomarker for recent alcohol use found in the blood that is specific to ethanol ingestion and can detect low-to heavy drinking levels.

Outcome measures

Outcome data not reported

Adverse Events

Risky Drinking, no dx of AUD, Has Panic or Depression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dx of AUD With or Without Panic or Depression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No dx of Alcohol Use Disorder, Panic or Depression

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

Karen Cropsey, Psy.D

University of Alabama at Birmingham

Phone: (205) 975-4204

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place