Clinical trial NCT00127231: Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
Official title: Brief Alcohol Intervention in HIV+ Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Alcoholism
Keywords: Controlled Clinical Trials, Randomized
Alcohol Consumption
Behavioral Research
HIV
Alcohol Abuse
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-08-05
Enrollment: 148
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Number of Drinking Days Out of the Past 90 Days
timeFrame: Baseline through 1 year follow-up
measure: Number of Binge Drinking Days Out of the Past 90 Days
timeFrame: Baseline through 12 month follow-up
Secondary outcomes:
measure: HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)
timeFrame: baseline through 1 year follow-up
measure: % of Patients Currently on Antiretroviral Therapy
timeFrame: baseline through 1 year follow-up
measure: Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex
timeFrame: Baseline to 12 month follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mary E. McCaul, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: