Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00127231
First received: August 3, 2005
Last updated: December 6, 2010
Last verified: December 2010
  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 3

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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Mean weekly drinking quantity/frequency [ Time Frame: Baseline through 1 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV clinic appointment adherence (kept/scheduled appointments) [ Time Frame: baseline through 1 year follow-up ] [ Designated as safety issue: No ]
  • HIV treatment adherence [ Time Frame: baseline through 1 year follow-up ] [ Designated as safety issue: No ]
  • Psychiatric symptoms [ Time Frame: baseline through 1 year follow-up ] [ Designated as safety issue: No ]
    Structured Clinical Diagnostic Interview-DSM-IV Beck Depression Inventory Hospital Anxiety Depression Scale

  • Percentage of women receiving HAART medication [ Time Frame: Baseline through 1 year follow-up ] [ Designated as safety issue: No ]
  • HIV disease progression - CD4 count and viral load [ Time Frame: Baseline through 1 year follow-up ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline through 1 year follow-up ] [ Designated as safety issue: No ]
    SF-12


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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127231

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Mary E. McCaul, Ph.D. Johns Hopkins University
  More Information

No publications provided

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

Keywords provided by Johns Hopkins University:
Controlled Clinical Trials, Randomized
Alcohol Consumption
Behavioral Research
HIV
Alcohol Abuse

Additional relevant MeSH terms:
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
Chemically-Induced 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

ClinicalTrials.gov processed this record on October 01, 2014