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Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women

This study is currently recruiting participants.
Verified June 2011 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Geetanjali Chander, MD MPH, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01125371
First received: May 17, 2010
Last updated: February 20, 2013
Last verified: June 2011
  Purpose

African American (AA) women are disproportionately affected by HIV/AIDs. The major risk factor for HIV acquisition among AA women is high-risk heterosexual sex, including unprotected vaginal and anal sex, and sex with a high-risk partner. Hazardous alcohol use has been associated with high risk sexual behaviors and prevalent gonorrhea among women attending an urban STI clinic, both of which increase a woman's vulnerability to HIV acquisition and transmission. This application proposes a randomized controlled trial (RCT) of a culturally tailored computer-directed brief alcohol intervention (CBI) enhanced with cell-phone booster calls using interactive voice response technology (IVR) among HIV-infected and at-risk AA women attending an urban STI Clinic. Hazardous drinking AA women (N=450) presenting with STI complaints will be randomized to one of three arms: 1) usual clinical care, 2) clinic-based, CBI, or 3) clinic-based, CBI + 3 booster calls using IVR and text messages. The CBI, an evidence-based based method for behavior change, will use principles of motivational interviewing, to counsel on: 1) alcohol use and 2) associated HIV/STI risk behaviors. Primary outcomes, measured at 3, 6, and 12 month intervals, include alcohol-related risk behaviors (number of binge drinking episodes, drinking days/week, and drinks per occasion), sexual risk behaviors (number of partners, episodes of unprotected vaginal/anal sex, episodes of sex while high), and occurrence of HIV/STI biomarkers. Prior to implementing the RCT, the CBI and IVR software messages will be revised to: 1) include the association between hazardous alcohol use and risky sexual behaviors, and 2) ensure their relevance and acceptability using quantitative/qualitative feedback from a sample of AA women attending a Baltimore City STI clinic. The proposed research focuses on a particularly vulnerable population of urban HIV at-risk and HIV-infected AA women seeking treatment in a public STI clinic and examines two novel BI intervention delivery strategies specifically tailored to be culturally/socially relevant to this minority population. If the intervention(s) prove to be effective, study findings will offer "real life" specialty care clinics a screening and intervention package that is practical, low cost, and easy to implement.


Condition Intervention Phase
Hazardous Alcohol Use
Binge Drinking
High Risk Sexual Behaviors
HIV Risk Reduction
HIV Infection
Behavioral: Computerized brief alcohol intervention with IVR booster calls
Behavioral: Computer delivered brief alcohol intervention
Behavioral: Attention Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Reduction in alcohol use [ Time Frame: 0, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    change alcohol-related risk behaviors (number of binge drinking episodes, drinking days/week, and drinks per occasion)


Secondary Outcome Measures:
  • sexual risk behaviors [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: No ]
    sexual risk behaviors (number of partners, episodes of unprotected vaginal/anal sex, episodes of sex while high), and occurrence of HIV/STI biomarkers


Estimated Enrollment: 450
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized Brief alcohol intervention + IVR phone calls
Computer-delivered brief alcohol intervention with booster phone calls delivered by interactive voice response technology + text messages
Behavioral: Computerized brief alcohol intervention with IVR booster calls
1) Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
Active Comparator: Computerized Brief Alcohol Intervention
Computerized Brief Alcohol Intervention without IVR booster calls
Behavioral: Computer delivered brief alcohol intervention
Clinic based computer delivered brief alcohol intervention delivered one time
Placebo Comparator: Attention Control
Attention control
Behavioral: Attention Control
20 minute attention control condition focused on dental hygiene delivered once

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 years of age or older;
  2. HIV infected or HIV negative and attending the Baltimore City Health Department sexually transmitted infection clinic for STI-related services
  3. Consumes an average of 8 or more drinks per week OR has had two binge drinking episodes (4 drinks/occasion) in the last 3 months
  4. sexually active
  5. Cognitively able to understand proposed research design (10 min screening, followed by random assignment to one of three study groups (if individual fulfills criteria for RCT enrollment);
  6. Able to speak and understand English
  7. Able and willing to receive text messages

Exclusion Criteria:

  1. Pregnant women will be excluded and referred directly to social work for referral to either alcohol or drug treatment due to ethical concerns of randomization to usual care.
  2. Currently enrolled in alcohol or drug treatment.
  3. Non-English Speaking.
  4. Actively Psychotic or have other severe mental health symptoms that would prevent appropriate participation in the brief intervention protocol.
  5. Planning on moving out of the area within 12 months of study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125371

Contacts
Contact: Mary Yep, BA 410-935-7698 myep1@jhmi.edu

Locations
United States, Maryland
Baltimore City Health Department STD Clinic Recruiting
Baltimore, Maryland, United States, 21205
Contact: Luke Johnson, DO    410-396-4398      
Sub-Investigator: Emily Erbelding, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Geetanjali Chander, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Geetanjali Chander, MD MPH, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01125371     History of Changes
Other Study ID Numbers: NIAAAGC018632, R01AA018632
Study First Received: May 17, 2010
Last Updated: February 20, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Hazardous alcohol use
Binge drinking
High risk sexual behaviors
HIV risk reduction

Additional relevant MeSH terms:
Alcohol Drinking
Ethanol
HIV Infections
Acquired Immunodeficiency Syndrome
Binge-Eating Disorder
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Drinking Behavior
Eating Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014