Drinking Water |
Water |
Clinical Trial: Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
This study is not yet open for patient recruitment.
Verified by National Institute on Alcohol Abuse and Alcoholism (NIAAA) August 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Alcohol Consumption Alcoholism | Behavior: Brief alcohol intervention based on Project Treat | Phase III |
MedlinePlus related topics: Alcohol Consumption; Alcoholism
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Brief Alcohol Intervention in HIV+ Women
Secondary Outcomes: HIV health outcomes; HIV treatment adherence; Quality of life; Psychiatric symptoms
Expected Total Enrollment: 200
Study start: September 2005; Expected completion: December 2008
Last follow-up: September 2008; Data entry closure: October 2008
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. 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.
Comparison(s): Standard HIV care
Eligibility
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)
Location and Contact Information
Maryland
Johns Hopkins Hospital, Baltimore, Maryland, 21205, United States
Mary E. McCaul, Ph.D., Principal Investigator, Johns Hopkins University
More Information
Last Updated: August 22, 2005
Record first received: August 3, 2005
ClinicalTrials.gov Identifier: NCT00127231
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

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