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

HIV Infections Clinical Trial

Official title:

Brief Alcohol Intervention in HIV+ Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127231
• Other study ID #: NIAAAMCC014500
• Secondary ID: R01AA014500K23AA
• Status: Completed
• Phase: N/A
• First received: August 3, 2005
• Last updated: November 2, 2017
• Start date: September 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcoholism
• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Drinking Days Out of the Past 90 Days		Baseline through 1 year follow-up
Primary	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	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
Secondary	% 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
Secondary	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