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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Alcoholism
• Intervention / Treatment: Behavioral: Brief alcohol intervention based on Project Treat; Behavioral: Standard care

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

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Drinking Days Out of the Past 90 Days		Baseline through 1 year follow-up
Number of Binge Drinking Days Out of the Past 90 Days	Number of days during the past 90 days on which women drank more than 3 standard drinks	Baseline through 12 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)	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	baseline through 1 year follow-up
% of Patients Currently on Antiretroviral Therapy	number of participants who are currently receiving antiretroviral therapy/total number of participants	baseline through 1 year follow-up
Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex	Number of days in the past 90 days on which participants reported having unprotected vaginal sex	Baseline to 12 month follow-up

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Mary E. McCaul, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: August 3, 2005
• First Submitted That Met QC Criteria: August 3, 2005
• First Posted (Estimate): August 5, 2005

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: HIV; Alcohol Consumption; Alcohol Abuse; Behavioral Research; Controlled Clinical Trials, Randomized
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: NIAAAMCC014500; R01AA014500 (U.S. NIH Grant/Contract); K23AA015313 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED