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

NCT00127231 | Completed Results DMC

• 3 other identifiers: NIAAAMCC014500R01AA014500K23AA015313
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Alcoholism

Keywords

Controlled Clinical Trials, Randomized; Alcohol Consumption; Behavioral Research; HIV; Alcohol Abuse

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)

  baseline through 1 year follow-up

• % of Patients Currently on Antiretroviral Therapy

  baseline through 1 year follow-up

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

  Baseline to 12 month follow-up

Study Arms (2)

1 Brief Intervention

EXPERIMENTAL

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

2 Standard Care Arm

ACTIVE COMPARATOR

Behavioral: Standard care

Interventions

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.

1 Brief Intervention

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.

2 Standard Care Arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

HIV Infections; Alcoholism; Alcohol Drinking

Interventions

Ethanol; Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Mary E McCaul
• Organization: Johns Hopkins University School of Medicine

mmccaul1@jhmi.edu

410-955-9526

Study Officials

• Mary E. McCaul, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2005
• First Posted: August 5, 2005
• Study Start: September 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 6, 2017
• Results First Posted: December 6, 2017

Record last verified: 2017-11

Locations

US (1)