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

Primary Purpose

HIV Infections, Alcoholism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief alcohol intervention based on Project Treat
Standard care
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Controlled Clinical Trials, Randomized, Alcohol Consumption, Behavioral Research, HIV, Alcohol Abuse

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Heavy/hazardous drinking levels (i.e., consuming 8 or more drinks per week, or have reported at least two heavy drinking occasions [4 or more drinks/drinking episode] in the last six months, or score positively on the CAGE or T-ACE). HIV-positive Receiving HIV care in Johns Hopkins Hospital (JHH) Moore Clinic Exclusion Criteria: Actively psychotic and other severe mental health symptoms Current enrollment in alcohol or drug treatment Current enrollment in Hopkins psychiatric services Pregnancy (because of the ethical concern of randomization to standard care)

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 Brief Intervention

2 Standard Care Arm

Arm 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.

Outcomes

Primary Outcome Measures

Number of Drinking Days Out of the Past 90 Days
Number of Binge Drinking Days Out of the Past 90 Days
Number of days during the past 90 days on which women drank more than 3 standard drinks

Secondary Outcome Measures

HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
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
% of Patients Currently on Antiretroviral Therapy
number of participants who are currently receiving antiretroviral therapy/total number of participants
Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
Number of days in the past 90 days on which participants reported having unprotected vaginal sex

Full Information

First Posted
August 3, 2005
Last Updated
November 2, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00127231
Brief Title
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
Official Title
Brief Alcohol Intervention in HIV+ Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether two brief counseling sessions reduce drinking and improve health outcomes in HIV-positive women who drink at heavy/hazardous levels. Also, the study seeks to compare hazardous drinking versus nonhazardous drinking women on a variety of alcohol, HIV and life quality outcome measures.
Detailed Description
Heavy alcohol use negatively impacts HIV/AIDS in several important ways. It increases HIV-risk behaviors, impairs the immune system and accelerates HIV disease progression. Heavy alcohol use also interferes with HIV care compliance, including appointment attendance and medication adherence. Women are particularly important targets for alcohol use interventions. The threshold for harmful alcohol effects is strikingly low in women, with two drinks per day placing women at risk for negative health consequences. Heavy/hazardous alcohol use is less likely to be detected in women receiving health services. Women may be less likely to seek and or engage in alcohol treatment services, making nontraditional care settings particularly important for reaching this population. This proposal tests the utility of a brief alcohol intervention for HIV+ women delivered in a medical setting. Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. 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. In addition, a comparison group of nonhazardous drinking, HIV+ women will be recruited. 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. The investigators hypothesize that women who receive the brief intervention will report lower mean weekly alcohol consumption and fewer heavy drinking episodes than women in standard care. The investigators also predict that women who receive brief intervention will adhere to their HIV medications and keep their health care appointments more consistently, and have improved HIV-related health outcomes. Finally, the investigators hypothesize that nonhazardous drinkers will have fewer psychiatric symptoms and better quality of life than hazardous drinking women. Comparison(s): Standard HIV care

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Alcoholism
Keywords
Controlled Clinical Trials, Randomized, Alcohol Consumption, Behavioral Research, HIV, Alcohol Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Brief Intervention
Arm Type
Experimental
Arm 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.
Arm Title
2 Standard Care Arm
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Brief alcohol intervention based on Project Treat
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Drinking Days Out of the Past 90 Days
Time Frame
Baseline through 1 year follow-up
Title
Number of Binge Drinking Days Out of the Past 90 Days
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
Secondary Outcome Measure Information:
Title
HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
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
Title
% of Patients Currently on Antiretroviral Therapy
Description
number of participants who are currently receiving antiretroviral therapy/total number of participants
Time Frame
baseline through 1 year follow-up
Title
Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heavy/hazardous drinking levels (i.e., consuming 8 or more drinks per week, or have reported at least two heavy drinking occasions [4 or more drinks/drinking episode] in the last six months, or score positively on the CAGE or T-ACE). HIV-positive Receiving HIV care in Johns Hopkins Hospital (JHH) Moore Clinic Exclusion Criteria: Actively psychotic and other severe mental health symptoms Current enrollment in alcohol or drug treatment Current enrollment in Hopkins psychiatric services Pregnancy (because of the ethical concern of randomization to standard care)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E. McCaul, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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