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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125371
• Other study ID #: NIAAAGC018632
• Secondary ID: R01AA018632
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: June 7, 2016

Study information

• Verified date: June 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: June 7, 2016
• Est. primary completion date: June 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• Computerized brief alcohol intervention
Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
• Attention Control
Attention Control: 20 minute attention control condition focused on dental hygiene delivered once

Locations

Country	Name	City	State
United States	Baltimore City Health Department STD Clinic	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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