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NCT01553682 · ClinicalTrials.gov registry record · NA
Project N-Liten- HIV Prevention for African American Women
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 560
- Enrollment target
NCT01553682: Completed NA study, sponsored by Emory University.
NCT01553682 is a NA study that has completed, run by Emory University. The registered enrollment target is 560 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01553682, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 560 participants
- Enrollment target
Study Summary
Young African-American women who report a higher frequency of alcohol use have particularly higher rates of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV) sex behaviors. Unfortunately, there are no evidence-based HIV interventions designed to be gender- and culturally-appropriate for this population. To address this, the investigators propose to add to the CDC-defined evidence-based intervention (DEBI), Horizons, a new intervention form, Group Motivational Enhancement Therapy (GMET), which has shown promise in reducing alcohol use and alcohol-related HIV risk-taking. To test how effective the combined Horizons+GMET alcohol-specific portion is, it will be evaluated with a time equivalent Horizons+attention control general health promotion (GHP) portion focusing on nutrition health promotion, and to an enhanced standard-of-care program. In this study, 600 young African American women, 18-24 years of age, who report 3 or more occasions where they drank alcohol in the past 90 days will be recruited to complete a four-part baseline assessment consisting of: 1. an audio computer assisted self interview (ACASI), 2. videotaped communication role plays to objectively measure communication skill ability (subsample), 3. provide a vaginal specimen to test for STDs and 4. Provide a urine pregnancy screen. After participants complete their baseline assessment, they will be randomly assigned to one of three conditions: 1. Horizons+GMET alcohol-specific condition, 2. a time-equivalent Horizons+GHP condition, or 3. an enhanced standard-of-care control condition. The GMET alcohol-specific component has shown to be effective in influencing several alcohol-specific concepts (attitudes, norms, self-efficacy) and reducing sexual risk-taking among culturally-diverse high-risk youth. The GMET alcohol-specific module was designed to increase woman's awareness of the unfavorable effects of alcohol on themselves, their sexual decision-making, and their male partne
Primary Outcome
Incident STD infection confirmed by laboratory PRC testing.
Interventions
- BEHAVIORAL Horizons+General Health Promotion (GHP)
- BEHAVIORAL Horizons+Motivational Enhancement Therapy (GMET)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-03 |
| Phase | NA |
What the finished NCT01553682 record still lists
NCT01553682 is an interventional study that assigns participants to a tested intervention. The registered 560 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 (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Horizons+General Health Promotion (GHP) is the first listed.
NCT01553682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01553682 about?
NCT01553682 is a clinical study titled "Project N-Liten- HIV Prevention for African American Women". Young African-American women who report a higher frequency of alcohol use have particularly higher rates of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV) sex behaviors. Unfortunately, there are no evidence-based HIV interventions designed to be gender- and culturally-ap...
What is the current status of trial NCT01553682?
This trial is currently completed. It is a NA study. The enrollment target is 560 participants. The study started on 2011-12. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01553682?
The interventions under investigation include: Horizons+General Health Promotion (GHP) (BEHAVIORAL), Horizons+Motivational Enhancement Therapy (GMET) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01553682?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01553682's enrollment target sits among peer trials
560 181st of 2000 higher than 1,818 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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