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

Completed · Not applicable

Conditions studied: Alcohol; Harmful Use, Binge Drinking, Risk Behavior, HIV Infection

In brief

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.

Key facts

Study ID

NCT01125371

Run by

Johns Hopkins University

People needed

439

Starts

2011-10-01

Expected to finish

2016-06-07

Last updated by the study team

2022-06-24

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age or older;
• HIV infected or HIV negative and attending the Baltimore City Health Department sexually transmitted infection clinic for STI-related services
• 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
• sexually active
• 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);
• Able to speak and understand English
• Able and willing to receive text messages

You may not qualify if…

• 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.
• Currently enrolled in alcohol or drug treatment.
• Non-English Speaking.
• Actively Psychotic or have other severe mental health symptoms that would prevent appropriate participation in the brief intervention protocol.
• Planning on moving out of the area within 12 months of study entry

Where it is running

• Baltimore City Health Department STD Clinic — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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