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

NCT01125371 | Completed Results DMC

• 2 other identifiers: NIAAAGC018632R01AA018632
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol; Harmful Use; Binge Drinking; Risk Behavior; HIV Infection

Keywords

Hazardous alcohol use; Binge drinking; High risk sexual behaviors; HIV risk reduction

Outcome Measures

Primary Outcomes (4)

• Change in Alcohol Use (Heavy Drinking Days)

  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)

  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)

  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)

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

  Baseline, 3, 6, and 12 months

Study Arms (3)

Computerized Brief Alcohol Intervention + IVR

EXPERIMENTAL

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

Behavioral: Computerized brief alcohol intervention + IVR booster calls

Computerized Brief Alcohol Intervention

ACTIVE COMPARATOR

Computerized Brief Alcohol Intervention only (CBI)

Behavioral: Computerized brief alcohol intervention

Attention Control

PLACEBO COMPARATOR

Attention control

Behavioral: Attention Control

Interventions

Computerized brief alcohol intervention + IVR booster calls BEHAVIORAL

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

Also known as: CBI+IVR+TM

Computerized Brief Alcohol Intervention + IVR

Computerized brief alcohol intervention BEHAVIORAL

Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time

Also known as: CBI

Computerized Brief Alcohol Intervention

Attention Control BEHAVIORAL

Attention Control: 20 minute attention control condition focused on dental hygiene delivered once

Attention Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Baltimore City Health Department STD Clinic

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Binge Drinking; Risk-Taking; HIV Infections

Interventions

Ethanol; Methods

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Results Point of Contact

• Title: Dr. Geetanjali Chander
• Organization: Johns Hopkins University

gchande1@jhmi.edu

443-287-2030

Study Officials

• Geetanjali Chander, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 18, 2010
• Study Start: October 1, 2011
• Primary Completion: June 7, 2016
• Study Completion: June 7, 2016
• Last Updated: June 24, 2022
• Results First Posted: June 24, 2022

Record last verified: 2022-06

Locations

US (1)