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| Sponsor: | Johns Hopkins University |
|---|---|
| Collaborator: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00127231 |
Purpose
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 |
|---|---|---|
|
HIV Infections Alcoholism |
Behavioral: Brief alcohol intervention based on Project Treat Behavioral: Standard care |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Brief Alcohol Intervention in HIV+ Women |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2007 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 Brief Intervention
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.
|
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.
|
| Active Comparator: 2 Standard Care Arm |
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.
|
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Mary E. McCaul, Ph.D. | Johns Hopkins University |
More Information
| Responsible Party: | Mary E. McCaul, Ph.D.; Geetanjali Chander, M.D., Johns Hopkins University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00127231 History of Changes |
| Other Study ID Numbers: | NIAAAMCC014500, R01AA014500, K23-AA015313 |
| Study First Received: | August 3, 2005 |
| Last Updated: | December 6, 2010 |
| Health Authority: | United States: Federal Government |
|
Controlled Clinical Trials, Randomized Alcohol Consumption Behavioral Research HIV Alcohol Abuse |
|
HIV Infections Acquired Immunodeficiency Syndrome Alcoholism Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Ethanol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
