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Completed

NCT Number: NCT00127231

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Brief alcohol intervention based on Project Treat

Behavioral

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.

Standard Care

Behavioral

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.

Primary outcomes

  1. Number of Drinking Days Out of the Past 90 Days

    Time frame: Baseline through 1 year follow-up

  2. Number of Binge Drinking Days Out of the Past 90 Days

    Time frame: Baseline through 12 month follow-up

    Number of days during the past 90 days on which women drank more than 3 standard drinks

Secondary outcomes

  1. HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)

    Time frame: baseline through 1 year follow-up

    the % of kept appointments out of scheduled appointments was determined for each participant, and then averaged for the set of participants at each time point

  2. % of Patients Currently on Antiretroviral Therapy

    Time frame: baseline through 1 year follow-up

    number of participants who are currently receiving antiretroviral therapy/total number of participants

  3. Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex

    Time frame: Baseline to 12 month follow-up

    Number of days in the past 90 days on which participants reported having unprotected vaginal sex

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Brief Alcohol Intervention in HIV+ Women

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 5, 2005
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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