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

Primary Purpose

Alcohol; Harmful Use, Binge Drinking, Risk Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized brief alcohol intervention + IVR booster calls
Computerized brief alcohol intervention
Attention Control
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol; Harmful Use focused on measuring Hazardous alcohol use, Binge drinking, High risk sexual behaviors, HIV risk reduction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Baltimore City Health Department STD Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Computerized Brief Alcohol Intervention + IVR

Computerized Brief Alcohol Intervention

Attention Control

Arm Description

Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)

Computerized Brief Alcohol Intervention only (CBI)

Attention control

Outcomes

Primary Outcome Measures

Change in Alcohol Use (Heavy Drinking Days)
Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.
Change in Alcohol Use (Drinking Days)
Change in alcohol-related risk behavior as assessed by the number of drinking days.
Change in Alcohol Use (Drinks Per Drinking Day)
Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day.
Change in Alcohol Use (Drinks Per Week)
Change in alcohol-related risk behavior as assessed by the standard drinks per week.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2010
Last Updated
June 1, 2022
Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01125371
Brief Title
Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women
Official Title
Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 7, 2016 (Actual)
Study Completion Date
June 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol; Harmful Use, Binge Drinking, Risk Behavior, HIV Infection
Keywords
Hazardous alcohol use, Binge drinking, High risk sexual behaviors, HIV risk reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized Brief Alcohol Intervention + IVR
Arm Type
Experimental
Arm Description
Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Arm Title
Computerized Brief Alcohol Intervention
Arm Type
Active Comparator
Arm Description
Computerized Brief Alcohol Intervention only (CBI)
Arm Title
Attention Control
Arm Type
Placebo Comparator
Arm Description
Attention control
Intervention Type
Behavioral
Intervention Name(s)
Computerized brief alcohol intervention + IVR booster calls
Other Intervention Name(s)
CBI+IVR+TM
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Computerized brief alcohol intervention
Other Intervention Name(s)
CBI
Intervention Description
Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
Primary Outcome Measure Information:
Title
Change in Alcohol Use (Heavy Drinking Days)
Description
Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.
Time Frame
Baseline, 3, 6, and 12 months
Title
Change in Alcohol Use (Drinking Days)
Description
Change in alcohol-related risk behavior as assessed by the number of drinking days.
Time Frame
Baseline, 3, 6, and 12 months
Title
Change in Alcohol Use (Drinks Per Drinking Day)
Description
Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day.
Time Frame
Baseline, 3, 6, and 12 months
Title
Change in Alcohol Use (Drinks Per Week)
Description
Change in alcohol-related risk behavior as assessed by the standard drinks per week.
Time Frame
Baseline, 3, 6, and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geetanjali Chander, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore City Health Department STD Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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

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