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

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Johns Hopkins University

Status

Completed

Conditions

Alcoholism
HIV Infections

Treatments

Behavioral: Standard care
Behavioral: Brief alcohol intervention based on Project Treat

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00127231
NIAAAMCC014500
K23AA015313 (U.S. NIH Grant/Contract)
R01AA014500 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment

148 patients

Sex

Female

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

148 participants in 2 patient groups

1 Brief Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Brief alcohol intervention based on Project Treat
2 Standard Care Arm
Active Comparator group
Treatment:
Behavioral: Standard care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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