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Clinical Trials/NCT01125371
NCT01125371
Completed
Not Applicable

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

Johns Hopkins University1 site in 1 country439 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol; Harmful Use
Sponsor
Johns Hopkins University
Enrollment
439
Locations
1
Primary Endpoint
Change in Alcohol Use (Heavy Drinking Days)
Status
Completed
Last Updated
3 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
June 7, 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in Alcohol Use (Heavy Drinking Days)

Time Frame: Baseline, 3, 6, and 12 months

Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.

Change in Alcohol Use (Drinking Days)

Time Frame: Baseline, 3, 6, and 12 months

Change in alcohol-related risk behavior as assessed by the number of drinking days.

Change in Alcohol Use (Drinks Per Week)

Time Frame: Baseline, 3, 6, and 12 months

Change in alcohol-related risk behavior as assessed by the standard drinks per week.

Change in Alcohol Use (Drinks Per Drinking Day)

Time Frame: Baseline, 3, 6, and 12 months

Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day.

Study Sites (1)

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