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

August 3, 2005
December 6, 2010
September 2007
November 2010   (final data collection date for primary outcome measure)
Mean weekly drinking quantity/frequency [ Time Frame: Baseline through 1 year follow-up ] [ Designated as safety issue: No ]
  • - Mean weekly drinking quantity/frequency
  • - Episodes of binge drinking
Complete list of historical versions of study NCT00127231 on ClinicalTrials.gov Archive Site
  • 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
  • - HIV health outcomes
  • - HIV treatment adherence
  • - Quality of life
  • - Psychiatric symptoms
Not Provided
Not Provided
 
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
Brief Alcohol Intervention in HIV+ 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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Alcoholism
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Brief alcohol intervention based on Project Treat
  • Active Comparator: 2 Standard Care Arm
    Intervention: Behavioral: Standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
November 2010
November 2010   (final data collection date for primary outcome measure)

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)
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00127231
NIAAAMCC014500, R01AA014500, K23-AA015313
Yes
Mary E. McCaul, Ph.D.; Geetanjali Chander, M.D., Johns Hopkins University School of Medicine
Johns Hopkins University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Mary E. McCaul, Ph.D. Johns Hopkins University
Johns Hopkins University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP