Trial Outcomes & Findings for Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women (NCT NCT01125371)
NCT ID: NCT01125371
Last Updated: 2022-06-24
Results Overview
Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
439 participants
Primary outcome timeframe
Baseline, 3, 6, and 12 months
Results posted on
2022-06-24
Participant Flow
Participant milestones
| Measure |
Computerized Brief Alcohol Intervention + IVR
Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
|
Computerized Brief Alcohol Intervention
Computerized Brief Alcohol Intervention only (CBI)
Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
|
Attention Control
Attention control
Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
|
|---|---|---|---|
|
Overall Study
STARTED
|
146
|
145
|
148
|
|
Overall Study
3 Months Follow up
|
127
|
131
|
135
|
|
Overall Study
6 Months Follow up
|
125
|
133
|
131
|
|
Overall Study
12 Months Follow up
|
120
|
130
|
129
|
|
Overall Study
COMPLETED
|
120
|
130
|
129
|
|
Overall Study
NOT COMPLETED
|
26
|
15
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women
Baseline characteristics by cohort
| Measure |
Computerized Brief Alcohol Intervention + IVR
n=146 Participants
Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
|
Computerized Brief Alcohol Intervention
n=145 Participants
Computerized Brief Alcohol Intervention only (CBI)
Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
|
Attention Control
n=148 Participants
Attention control
Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
|
Total
n=439 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32 years
n=99 Participants
|
31 years
n=107 Participants
|
31 years
n=206 Participants
|
31 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
439 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
African American
|
131 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
388 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
51 Participants
n=7 Participants
|
|
Level of Education
< Grade 12
|
42 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
133 Participants
n=7 Participants
|
|
Level of Education
GED or Higher
|
104 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
306 Participants
n=7 Participants
|
|
Income
$0 - 5,000
|
77 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
215 Participants
n=7 Participants
|
|
Income
$5,001 - 10,000
|
23 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
83 Participants
n=7 Participants
|
|
Income
$10,001 - 15,000
|
18 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
|
Income
$15,001 or more
|
28 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
77 Participants
n=7 Participants
|
|
HIV Positive Status
No
|
132 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
401 Participants
n=7 Participants
|
|
HIV Positive Status
Yes
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
HIV Positive Status
Unsure
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Illicit Drug Use
|
95 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
285 Participants
n=7 Participants
|
|
Marijuana Use
|
78 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
221 Participants
n=7 Participants
|
|
Cocaine Use
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Heroin Use
|
16 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Injection Drug Use
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Non-medical Use of Prescription
|
9 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
PHQ Depressive Symptoms
|
6 score on a scale
n=99 Participants
|
7 score on a scale
n=107 Participants
|
7.5 score on a scale
n=206 Participants
|
7 score on a scale
n=7 Participants
|
|
PHQ Panic Symptoms
|
35 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
130 Participants
n=7 Participants
|
|
Post-Traumatic Stress Disorder (PTSD)
|
46 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
151 Participants
n=7 Participants
|
|
Generalized Anxiety Symptoms
None
|
81 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
216 Participants
n=7 Participants
|
|
Generalized Anxiety Symptoms
Mild
|
39 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
127 Participants
n=7 Participants
|
|
Generalized Anxiety Symptoms
Moderate
|
15 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Generalized Anxiety Symptoms
Severe
|
10 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Generalized Anxiety Symptoms
Missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
MINI Assessment
Neither
|
54 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
141 Participants
n=7 Participants
|
|
MINI Assessment
Abuse
|
23 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
81 Participants
n=7 Participants
|
|
MINI Assessment
Dependence
|
69 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
217 Participants
n=7 Participants
|
|
Audit Score
<7
|
40 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
118 Participants
n=7 Participants
|
|
Audit Score
7-12
|
34 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
128 Participants
n=7 Participants
|
|
Audit Score
≥13
|
72 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
193 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.
Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.
Outcome measures
| Measure |
Computerized Brief Alcohol Intervention + IVR
n=146 Participants
Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
|
Computerized Brief Alcohol Intervention
n=145 Participants
Computerized Brief Alcohol Intervention only (CBI)
Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
|
Attention Control
n=148 Participants
Attention control
Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
|
|---|---|---|---|
|
Change in Alcohol Use (Heavy Drinking Days)
Baseline
|
6 heavy drinking days
Interval 2.0 to 13.0
|
6 heavy drinking days
Interval 3.0 to 11.0
|
6 heavy drinking days
Interval 2.0 to 11.0
|
|
Change in Alcohol Use (Heavy Drinking Days)
3 months
|
3 heavy drinking days
Interval 1.0 to 7.0
|
3 heavy drinking days
Interval 1.0 to 8.0
|
3 heavy drinking days
Interval 0.0 to 8.0
|
|
Change in Alcohol Use (Heavy Drinking Days)
6 months
|
3 heavy drinking days
Interval 0.0 to 7.0
|
4 heavy drinking days
Interval 1.0 to 8.0
|
2 heavy drinking days
Interval 0.0 to 8.0
|
|
Change in Alcohol Use (Heavy Drinking Days)
12 months
|
2 heavy drinking days
Interval 0.0 to 6.0
|
2 heavy drinking days
Interval 0.0 to 6.0
|
3 heavy drinking days
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.
Change in alcohol-related risk behavior as assessed by the number of drinking days.
Outcome measures
| Measure |
Computerized Brief Alcohol Intervention + IVR
n=146 Participants
Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
|
Computerized Brief Alcohol Intervention
n=145 Participants
Computerized Brief Alcohol Intervention only (CBI)
Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
|
Attention Control
n=148 Participants
Attention control
Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
|
|---|---|---|---|
|
Change in Alcohol Use (Drinking Days)
Baseline
|
9 drinking days
Interval 5.0 to 15.0
|
9 drinking days
Interval 6.0 to 14.0
|
8.5 drinking days
Interval 5.8 to 15.0
|
|
Change in Alcohol Use (Drinking Days)
3 months
|
6.4 drinking days
Interval 3.0 to 10.0
|
7 drinking days
Interval 4.0 to 12.0
|
6 drinking days
Interval 2.1 to 11.0
|
|
Change in Alcohol Use (Drinking Days)
6 months
|
6 drinking days
Interval 2.0 to 11.0
|
7 drinking days
Interval 2.0 to 12.0
|
5 drinking days
Interval 2.0 to 11.0
|
|
Change in Alcohol Use (Drinking Days)
12 months
|
6 drinking days
Interval 2.0 to 11.0
|
6 drinking days
Interval 2.0 to 11.0
|
6 drinking days
Interval 2.0 to 10.0
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.
Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day.
Outcome measures
| Measure |
Computerized Brief Alcohol Intervention + IVR
n=146 Participants
Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
|
Computerized Brief Alcohol Intervention
n=145 Participants
Computerized Brief Alcohol Intervention only (CBI)
Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
|
Attention Control
n=148 Participants
Attention control
Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
|
|---|---|---|---|
|
Change in Alcohol Use (Drinks Per Drinking Day)
Baseline
|
5.6 drinks per drinking day
Interval 3.2 to 8.8
|
5.6 drinks per drinking day
Interval 3.3 to 9.3
|
6.1 drinks per drinking day
Interval 3.7 to 7.8
|
|
Change in Alcohol Use (Drinks Per Drinking Day)
3 months
|
3.7 drinks per drinking day
Interval 2.2 to 6.2
|
4.2 drinks per drinking day
Interval 2.3 to 6.4
|
4.1 drinks per drinking day
Interval 2.0 to 6.5
|
|
Change in Alcohol Use (Drinks Per Drinking Day)
6 months
|
3.8 drinks per drinking day
Interval 1.4 to 6.4
|
4.4 drinks per drinking day
Interval 2.1 to 6.8
|
3.8 drinks per drinking day
Interval 1.7 to 6.2
|
|
Change in Alcohol Use (Drinks Per Drinking Day)
12 months
|
3.0 drinks per drinking day
Interval 1.5 to 5.7
|
3.4 drinks per drinking day
Interval 1.4 to 5.6
|
3.8 drinks per drinking day
Interval 1.4 to 6.5
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.
Change in alcohol-related risk behavior as assessed by the standard drinks per week.
Outcome measures
| Measure |
Computerized Brief Alcohol Intervention + IVR
n=146 Participants
Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
|
Computerized Brief Alcohol Intervention
n=145 Participants
Computerized Brief Alcohol Intervention only (CBI)
Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
|
Attention Control
n=148 Participants
Attention control
Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
|
|---|---|---|---|
|
Change in Alcohol Use (Drinks Per Week)
Baseline
|
12.0 drinks per week
Interval 4.7 to 28.7
|
12.4 drinks per week
Interval 5.8 to 25.5
|
12.0 drinks per week
Interval 5.3 to 25.3
|
|
Change in Alcohol Use (Drinks Per Week)
3 months
|
6.5 drinks per week
Interval 2.1 to 13.6
|
7.0 drinks per week
Interval 2.9 to 15.4
|
6.4 drinks per week
Interval 1.6 to 16.1
|
|
Change in Alcohol Use (Drinks Per Week)
6 months
|
5.6 drinks per week
Interval 1.1 to 13.1
|
6.8 drinks per week
Interval 1.4 to 15.7
|
4.4 drinks per week
Interval 0.9 to 15.7
|
|
Change in Alcohol Use (Drinks Per Week)
12 months
|
4.3 drinks per week
Interval 1.0 to 11.5
|
5.3 drinks per week
Interval 1.0 to 12.4
|
5.4 drinks per week
Interval 1.4 to 11.2
|
Adverse Events
Computerized Brief Alcohol Intervention + IVR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Computerized Brief Alcohol Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place