Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women
NCT01125371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 439
Last updated 2022-06-24
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 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.
Conditions
- Alcohol; Harmful Use
- Binge Drinking
- Risk Behavior
- HIV Infection
Interventions
- BEHAVIORAL
-
Computerized brief alcohol intervention + IVR booster calls
1\) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
- BEHAVIORAL
-
Computerized brief alcohol intervention
Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
- BEHAVIORAL
-
Attention Control
Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
Sponsors & Collaborators
-
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH - lead OTHER
Principal Investigators
-
Geetanjali Chander, MD · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2016-06-07
- Completion
- 2016-06-07
Countries
- United States
Study Locations
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