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Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women

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ClinicalTrials.gov Identifier: NCT00127231
Recruitment Status : Completed
First Posted : August 5, 2005
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Alcoholism
Interventions Behavioral: Brief alcohol intervention based on Project Treat
Behavioral: Standard care
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 Brief Intervention 2 Standard Care Arm
Hide Arm/Group Description

The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
Period Title: Overall Study
Started 74 74
Completed 68 68
Not Completed 6 6
Arm/Group Title 1 Brief Intervention 2 Standard Care Arm Total
Hide Arm/Group Description

The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms. Total of all reporting groups
Overall Number of Baseline Participants 74 74 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 74 participants 148 participants
46.27  (7.07) 44.86  (9.1) 45.56  (8.08)
[1]
Measure Description: Age at baseline assessment (Years)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Female
74
 100.0%
74
 100.0%
148
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Sex at baseline assessment
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
American Indian or Alaska Native
0
   0.0%
2
   2.7%
2
   1.4%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
67
  90.5%
60
  81.1%
127
  85.8%
White
7
   9.5%
12
  16.2%
19
  12.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Race at baseline assessment
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 74 participants 74 participants 148 participants
74 74 148
Employment %   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Working part-time or full-time
21
  28.4%
28
  37.8%
49
  33.1%
Unemployed
53
  71.6%
46
  62.2%
99
  66.9%
[1]
Measure Description: Current employment status at baseline assessment
Income, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Dollars
Number Analyzed 74 participants 74 participants 148 participants
8497.38  (7166.03) 8189.19  (7239.17) 8343.28  (7202.60)
[1]
Measure Description: Annual income at baseline assessment (US dollars)
Undetectable HIV-1 RNA %  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Undetectable HIV-1 RNA (<50 copies)
29
  39.2%
31
  41.9%
60
  40.5%
Detectable HIV-1 RNA
45
  60.8%
43
  58.1%
88
  59.5%
CD4 count, Continuous  
Mean (Standard Deviation)
Unit of measure:  Cells/mm3
Number Analyzed 74 participants 74 participants 148 participants
398.11  (269.02) 393.24  (236.78) 395.68  (252.9)
AUDIT score, continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 74 participants 74 participants 148 participants
11.9  (8.7) 12.3  (8.9) 12.1  (8.8)
[1]
Measure Description: Score on the Alcohol Use Disorders Identification Test (AUDIT) at baseline assessment. The AUDIT ranges from 0 (minimum) to 40 (maximum). The higher the score, the more likely it is that the individual has an alcohol use disorder.
Total number of drinking days out of the past 90 days  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 74 participants 74 participants 148 participants
34.03  (29.47) 30.45  (27.57) 32.24  (28.52)
Number of standard drinks per episode, continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Standard drinks
Number Analyzed 74 participants 74 participants 148 participants
9.69  (9.13) 9.55  (6.42) 9.62  (7.78)
[1]
Measure Description: A standard drink is any drink that contains about 14 grams of pure alcohol. One standard drink is typically considered to be 12 fluid ounces of beer, 4 - 5 fluid ounces of wine, or 1.5 fluid ounces of 80 proof liquor.
Number of participants with illicit drug use in past 6 months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
50
  67.6%
52
  70.3%
102
  68.9%
1.Primary Outcome
Title Number of Drinking Days Out of the Past 90 Days
Hide Description [Not Specified]
Time Frame Baseline through 1 year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in analyses although 6 participants from each arm did not complete the study due to loss to follow up
Arm/Group Title 1 Brief Intervention 2 Standard Care Arm
Hide Arm/Group Description:

The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
Overall Number of Participants Analyzed 74 74
Mean (Standard Deviation)
Unit of Measure: days
Baseline Number Analyzed 74 participants 74 participants
34.03  (29.47) 30.45  (27.57)
3-month follow-up Number Analyzed 55 participants 57 participants
13.58  (19.89) 20.22  (25.27)
6-month follow-up Number Analyzed 62 participants 62 participants
14.42  (22.20) 24.48  (26.78)
12-month follow-up Number Analyzed 64 participants 64 participants
15.96  (24.07) 20.83  (27.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Brief Intervention, 2 Standard Care Arm
Comments Drinking frequency was analyzed using a generalized binomial mixed-effects model with the logit link function and a random intercept. The use of a binomial distribution was indicated for this analysis because the outcome was assessed using a 90-day TLFB interview, which has a cap at 90 days.
Type of Statistical Test Equivalence
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.23 to 0.75
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Binge Drinking Days Out of the Past 90 Days
Hide Description Number of days during the past 90 days on which women drank more than 3 standard drinks
Time Frame Baseline through 12 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all subjects participated in every follow-up interview.
Arm/Group Title 1 Brief Intervention 2 Standard Care Arm
Hide Arm/Group Description:

The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
Overall Number of Participants Analyzed 74 74
Mean (Standard Deviation)
Unit of Measure: days out of past 90 days
Baseline Number Analyzed 74 participants 74 participants
24.91  (26.99) 26.71  (28.55)
3-month follow-up Number Analyzed 55 participants 57 participants
7.68  (13.75) 13.95  (22.11)
6-month follow-up Number Analyzed 62 participants 62 participants
12.07  (21.61) 16.14  (23.63)
12 month follow-up Number Analyzed 64 participants 64 participants
12.76  (23.42) 13.23  (20.40)
3.Secondary Outcome
Title HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
Hide Description the % of kept appointments out of scheduled appointments was determined for each participant, and then averaged for the set of participants at each time point
Time Frame baseline through 1 year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Brief Intervention 2 Standard Care Arm
Hide Arm/Group Description:

The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
Overall Number of Participants Analyzed 74 74
Mean (Standard Deviation)
Unit of Measure: percentage of kept/scheduled appointment
Baseline 63.40  (23.47) 58.59  (23.66)
3-month follow-up 70.11  (25.15) 60.57  (33.69)
6-month follow-up 67.87  (28.57) 62.22  (33.98)
12-month follow-up 63.33  (23.82) 56.63  (27.91)
4.Secondary Outcome
Title % of Patients Currently on Antiretroviral Therapy
Hide Description number of participants who are currently receiving antiretroviral therapy/total number of participants
Time Frame baseline through 1 year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Brief Intervention 2 Standard Care Arm
Hide Arm/Group Description:

The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 72.97 67.57
3-month follow-up 78.18 68.42
6-month follow-up 75.81 70.97
12-month follow-up 84.38 76.56
5.Secondary Outcome
Title Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
Hide Description Number of days in the past 90 days on which participants reported having unprotected vaginal sex
Time Frame Baseline to 12 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all subjects participated in every follow-up interview.
Arm/Group Title 1 Brief Intervention 2 Standard Care Arm
Hide Arm/Group Description:

The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
Overall Number of Participants Analyzed 74 74
Mean (Standard Deviation)
Unit of Measure: days
Baseline Number Analyzed 74 participants 74 participants
2.68  (8.61) 3.31  (9.21)
3-month follow-up Number Analyzed 55 participants 57 participants
2.56  (12.15) 3.06  (10.31)
6-month follow-up Number Analyzed 62 participants 62 participants
2.31  (7.83) 1.35  (4.54)
12-month follow-up Number Analyzed 64 participants 64 participants
1.59  (5.11) 4.74  (13.78)
Time Frame Baseline to 12 month follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Brief Intervention 2 Standard Care Arm
Hide Arm/Group Description

The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.

Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
All-Cause Mortality
1 Brief Intervention 2 Standard Care Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/74 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
1 Brief Intervention 2 Standard Care Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/74 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Brief Intervention 2 Standard Care Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/74 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mary E McCaul
Organization: Johns Hopkins University School of Medicine
Phone: 410-955-9526
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00127231     History of Changes
Other Study ID Numbers: NIAAAMCC014500
R01AA014500 ( U.S. NIH Grant/Contract )
K23AA015313 ( U.S. NIH Grant/Contract )
First Submitted: August 3, 2005
First Posted: August 5, 2005
Results First Submitted: August 29, 2017
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017