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NCT01125371 · ClinicalTrials.gov registry record · NA
Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 439
- Enrollment target
NCT01125371: Completed NA study, sponsored by Johns Hopkins University.
NCT01125371 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 439 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01125371, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 439 participants
- Enrollment target
Study 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 clini
Primary Outcome
Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.
Interventions
- BEHAVIORAL Attention Control
- BEHAVIORAL Computerized brief alcohol intervention + IVR booster calls
- BEHAVIORAL Computerized brief alcohol intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-06-07 |
| Phase | NA |
What the finished NCT01125371 record still lists
NCT01125371 is an interventional study that assigns participants to a tested intervention. The registered 439 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 3 interventions - of which Attention Control is the first listed.
NCT01125371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01125371 about?
NCT01125371 is a clinical study titled "Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women". 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 sexu...
What is the current status of trial NCT01125371?
This trial is currently completed. It is a NA study. The enrollment target is 439 participants. The study started on 2011-10. Estimated completion is 2016-06-07.
What interventions are being tested in trial NCT01125371?
The interventions under investigation include: Attention Control (BEHAVIORAL), Computerized brief alcohol intervention + IVR booster calls (BEHAVIORAL), Computerized brief alcohol intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01125371?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01125371's enrollment target sits among peer trials
439 235th of 2000 higher than 1,766 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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