CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 439 enrolled
Drug / intervention
Computerized brief alcohol intervention + IVR booster calls +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01125371
NCT01125371N/ACompleted

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

Johns Hopkins University·interventional·Posted May 18, 2010·Updated Jun 24, 2022

In Brief

A clinical study evaluating Computerized brief alcohol intervention + IVR booster calls, Computerized brief alcohol intervention, and 1 other intervention for Alcohol; Harmful Use and 3 related conditions. Completed, enrolled 439 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2010
Enrollment StartOct 1, 2011
Primary CompletionJun 7, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.1 years ago

Interventions

Computerized brief alcohol intervention + IVR booster callsbehavioral

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 interventionbehavioral

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

Attention Controlbehavioral

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