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

May 17, 2010
February 20, 2013
October 2011
September 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01125371 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women
Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hazardous Alcohol Use
  • Binge Drinking
  • High Risk Sexual Behaviors
  • HIV Risk Reduction
  • HIV Infection
  • 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
  • Behavioral: Computer delivered brief alcohol intervention
    Clinic based computer delivered brief alcohol intervention delivered one time
  • Behavioral: Attention Control
    20 minute attention control condition focused on dental hygiene delivered once
  • 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
    Intervention: Behavioral: Computerized brief alcohol intervention with IVR booster calls
  • Active Comparator: Computerized Brief Alcohol Intervention
    Computerized Brief Alcohol Intervention without IVR booster calls
    Intervention: Behavioral: Computer delivered brief alcohol intervention
  • Placebo Comparator: Attention Control
    Attention control
    Intervention: Behavioral: Attention Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
September 2015
September 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Mary Yep, BA 410-935-7698 myep1@jhmi.edu
United States
 
NCT01125371
NIAAAGC018632, R01AA018632
Yes
Geetanjali Chander, MD MPH, Johns Hopkins University
Johns Hopkins University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Geetanjali Chander, MD Johns Hopkins University
Johns Hopkins University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP