Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
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.
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
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Brief alcohol intervention based on Project Treat, Standard care
Johns Hopkins Hospital
Johns Hopkins University
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00127231
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Standard Of Care
The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.
A way of providing health care that is guided by a thoughtful integration of the best available scientific knowledge with clinical expertise. This approach allows the practitioner to critically assess research data, clinical guidelines, and other information resources in order to correctly identify the clinical problem, apply the most high-quality intervention, and re-evaluate the outcome for future improvement.
Groups that serve as a standard for comparison in experimental studies. They are similar in relevant characteristics to the experimental group but do not receive the experimental intervention.
Evidence-based Emergency Medicine
A way of providing emergency medical care that is guided by a thoughtful integration of the best available scientific knowledge with clinical expertise in EMERGENCY MEDICINE. This approach allows the practitioner to critically assess research data, clinical guidelines, and other information resources in order to correctly identify the clinical problem, apply the most high-quality intervention, and re-evaluate the outcome for future improvement.
Process Assessment (health Care)
An evaluation procedure that focuses on how care is delivered, based on the premise that there are standards of performance for activities undertaken in delivering patient care, in which the specific actions taken, events occurring, and human interactions are compared with accepted standards.
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