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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women

Brief Summary: 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) and text messages 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 clini

Detailed Summary:
Sponsor: Johns Hopkins University

Current Primary Outcome: Reduction in alcohol use [ Time Frame: 0, 3, 6, and 12 months ]

change alcohol-related risk behaviors (number of binge drinking episodes, drinking days/week, and drinks per occasion)


Original Primary Outcome: Same as current

Current Secondary Outcome: sexual risk behaviors [ Time Frame: 0, 3, 6, 12 months ]

sexual risk behaviors (number of partners, episodes of unprotected vaginal/anal sex, episodes of sex while high), and occurrence of HIV/STI biomarkers


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: May 17, 2010
Date Started: October 2011
Date Completion: December 31, 2018
Last Updated: February 28, 2017
Last Verified: February 2017