N/A
N=439
Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women
Alcohol; Harmful Use · Binge Drinking · Risk Behavior · HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT01125371 ↗Enrolled (actual)
439
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Change in Alcohol Use (Heavy Drinking Days) — 6; 6; 6; 3 heavy drinking days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computerized brief alcohol intervention + IVR booster calls (Behavioral); Computerized brief alcohol intervention (Behavioral); Attention Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alcohol Use (Heavy Drinking Days) |
6; 6; 6; 3; 3; 3 | — |
| PRIMARY Change in Alcohol Use (Drinking Days) |
9; 9; 8.5; 6.4; 7; 6 | — |
| PRIMARY Change in Alcohol Use (Drinks Per Drinking Day) |
5.6; 5.6; 6.1; 3.7; 4.2; 4.1 | — |
| PRIMARY Change in Alcohol Use (Drinks Per Week) |
12.0; 12.4; 12.0; 6.5; 7.0; 6.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01125371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.