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

NCT ID: NCT01125371

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 439 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-06-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Computerized Brief Alcohol Intervention + IVR

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

Group Type: EXPERIMENTAL

Computerized brief alcohol intervention + IVR booster calls

Intervention Type: 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

Computerized Brief Alcohol Intervention

Computerized Brief Alcohol Intervention only (CBI)

Group Type: ACTIVE_COMPARATOR

Computerized brief alcohol intervention

Intervention Type: BEHAVIORAL

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

Attention Control

Attention control

Group Type: PLACEBO_COMPARATOR

Attention Control

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Computerized brief alcohol intervention

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

Intervention Type: BEHAVIORAL

Attention Control

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

Intervention Type: BEHAVIORAL

Other Intervention Names

CBI+IVR+TM; CBI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geetanjali Chander, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Baltimore City Health Department STD Clinic

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01AA018632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAGC018632

Identifier Type: -

Identifier Source: org_study_id