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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00127231 |
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.
Condition | Intervention | Phase |
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HIV Infections Alcoholism |
Behavioral: Brief alcohol intervention based on Project Treat Behavioral: Standard care |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Brief Alcohol Intervention in HIV+ Women |
Estimated Enrollment: | 300 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Brief Intervention: Experimental
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.
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Behavioral: Brief alcohol intervention based on Project Treat
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.
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2 Standard Care Arm: Active Comparator |
Behavioral: Standard care
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.
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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
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary E. McCaul, Ph.D. | 410-955-5439 | mmccaul1@jhmi.edu |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Mary E. McCaul, Ph.D. 410-955-5439 mmccaul1@jhmi.edu |
Principal Investigator: | Mary E. McCaul, Ph.D. | Johns Hopkins University |
Responsible Party: | Johns Hopkins University School of Medicine ( Mary E. McCaul, Ph.D.; Geetanjali Chander, M.D. ) |
Study ID Numbers: | NIAAAMCC014500, R01-AA014500, K23-AA015313 |
Study First Received: | August 3, 2005 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00127231 History of Changes |
Health Authority: | United States: Federal Government |
Controlled Clinical Trials, Randomized Alcohol Consumption Behavioral Research |
HIV Alcohol Abuse Alcohol Consumption |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Central Nervous System Depressants Disorders of Environmental Origin Alcohol Drinking Immunologic Deficiency Syndromes Virus Diseases Anti-Infective Agents, Local |
HIV Seropositivity Mental Disorders HIV Infections Alcoholism Sexually Transmitted Diseases Substance-Related Disorders Alcohol-Related Disorders Retroviridae Infections Ethanol |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Physiological Effects of Drugs Disorders of Environmental Origin Infection Mental Disorders Therapeutic Uses Substance-Related Disorders Alcohol-Related Disorders Retroviridae Infections Ethanol RNA Virus Infections |
Immune System Diseases Acquired Immunodeficiency Syndrome Central Nervous System Depressants Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Anti-Infective Agents, Local HIV Infections Sexually Transmitted Diseases Alcoholism Lentivirus Infections Central Nervous System Agents |