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

Not Applicable

Completed

Conditions: HIV Infections
Alcoholism

Registration Number: NCT00127231

Lead Sponsor: Johns Hopkins University

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 148

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Binge Drinking Days Out of the Past 90 Days	Baseline through 12 month follow-up	Number of days during the past 90 days on which women drank more than 3 standard drinks
Number of Drinking Days Out of the Past 90 Days	Baseline through 1 year follow-up

Secondary Outcome Measures

Name	Time	Method
HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)	baseline through 1 year follow-up	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	baseline through 1 year follow-up	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	Baseline to 12 month follow-up	Number of days in the past 90 days on which participants reported having unprotected vaginal sex