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

June 1, 2022 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

439

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Baltimore City Health Department STD Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 18 years of age or older;
  2. HIV infected or HIV negative and attending the Baltimore City Health Department sexually transmitted infection clinic for STI-related services
  3. 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
  4. sexually active
  5. 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);
  6. Able to speak and understand English
  7. Able and willing to receive text messages

Exclusion Criteria:

  1. 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.
  2. Currently enrolled in alcohol or drug treatment.
  3. Non-English Speaking.
  4. Actively Psychotic or have other severe mental health symptoms that would prevent appropriate participation in the brief intervention protocol.
  5. Planning on moving out of the area within 12 months of study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computerized Brief Alcohol Intervention + IVR
Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
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
Other Names:
  • CBI+IVR+TM
Active Comparator: Computerized Brief Alcohol Intervention
Computerized Brief Alcohol Intervention only (CBI)
Behavioral: Computerized brief alcohol intervention
Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
Other Names:
  • CBI
Placebo Comparator: Attention Control
Attention control
Behavioral: Attention Control
Attention Control: 20 minute attention control condition focused on dental hygiene delivered once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3, 6, and 12 months
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.
Baseline, 3, 6, and 12 months
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.
Baseline, 3, 6, and 12 months
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.
Baseline, 3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

June 7, 2016

Study Completion (Actual)

June 7, 2016

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (Estimate)

May 18, 2010

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAGC018632
  • R01AA018632 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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