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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127231
First Posted: August 5, 2005
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: August 29, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
1 Brief Intervention

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.

2 Standard Care Arm 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.

Participant Flow:   Overall Study
    1 Brief Intervention   2 Standard Care Arm
STARTED   74   74 
COMPLETED   68   68 
NOT COMPLETED   6   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
1 Brief Intervention

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.

2 Standard Care Arm 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 Total of all reporting groups

Baseline Measures
   1 Brief Intervention   2 Standard Care Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 74   74   148 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 46.27  (7.07)   44.86  (9.1)   45.56  (8.08) 
[1] Age at baseline assessment (Years)
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female      74 100.0%      74 100.0%      148 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
[1] Sex at baseline assessment
Race (NIH/OMB) [1] 
[Units: Participants]
Count of 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] Race at baseline assessment
Region of Enrollment 
[Units: Participants]
     
United States   74   74   148 
Employment % [1] 
[Units: Participants]
Count of 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] Current employment status at baseline assessment
Income, Continuous [1] 
[Units: Dollars]
Mean (Standard Deviation)
 8497.38  (7166.03)   8189.19  (7239.17)   8343.28  (7202.60) 
[1] Annual income at baseline assessment (US dollars)
Undetectable HIV-1 RNA % 
[Units: Participants]
Count of 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 
[Units: Cells/mm3]
Mean (Standard Deviation)
 398.11  (269.02)   393.24  (236.78)   395.68  (252.9) 
AUDIT score, continuous [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 11.9  (8.7)   12.3  (8.9)   12.1  (8.8) 
[1] 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 
[Units: Days]
Mean (Standard Deviation)
 34.03  (29.47)   30.45  (27.57)   32.24  (28.52) 
Number of standard drinks per episode, continuous [1] 
[Units: Standard drinks]
Mean (Standard Deviation)
 9.69  (9.13)   9.55  (6.42)   9.62  (7.78) 
[1] 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 
[Units: Participants]
Count of Participants
 50   52   102 


  Outcome Measures
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1.  Primary:   Number of Drinking Days Out of the Past 90 Days   [ Time Frame: Baseline through 1 year follow-up ]

2.  Primary:   Number of Binge Drinking Days Out of the Past 90 Days   [ Time Frame: Baseline through 12 month follow-up ]

3.  Secondary:   HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)   [ Time Frame: baseline through 1 year follow-up ]

4.  Secondary:   % of Patients Currently on Antiretroviral Therapy   [ Time Frame: baseline through 1 year follow-up ]

5.  Secondary:   Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex   [ Time Frame: Baseline to 12 month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: mmccaul1@jhmi.edu



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