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

Study Overview
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Brief Summary
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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
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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

Official Title
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Brief Alcohol Intervention in HIV+ Women

Conditions
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Alcoholism, HIV Infections

Intervention / Treatment
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* Behavioral: Brief alcohol intervention based on Project Treat
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Brief Intervention<br>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. | Behavioral: Brief alcohol intervention based on Project Treat<br>* 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.<br>|
| Active Comparator: 2 Standard Care Arm<br> | Behavioral: Standard care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Drinking Days Out of the Past 90 Days |  | Baseline through 1 year follow-up | 
| 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 | Baseline through 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline through 1 year follow-up | 
| % of Patients Currently on Antiretroviral Therapy | number of participants who are currently receiving antiretroviral therapy/total number of participants | baseline through 1 year follow-up | 
| 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 | Baseline to 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Controlled Clinical Trials, Randomized, Alcohol Consumption, Behavioral Research, HIV, Alcohol Abuse