NCT01125371

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-06-07
• Completion: 2016-06-07
• First posted: 2010-05-18
• Last updated: 2022-06-24
• Results posted: 2022-06-24

Locations

1 site across 1 country: United States