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NCT01387646 · ClinicalTrials.gov registry record · Phase 2
Behavioral Intervention for Minority Adolescent Women
A Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 2
- Development phase
- 562
- Enrollment target
NCT01387646: Completed Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01387646 is a Phase 2 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 562 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (323% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01387646, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 562 participants
- Enrollment target
Study Summary
The purpose of this Stage II clinical trial is to test the efficacy of a culturally sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy and abuse by changing high-risk sexual behaviors, decreasing substance use and encouraging contraceptive use. Its primary goal is to expand risk-reduction interventions created in previous studies to further increase intervention efficacy for this particularly vulnerable, high-risk group. An adolescent intervention has been created and pilot tested in developmental studies. Results indicated reductions in substance use, risk behaviors, unintended pregnancy, STI and abuse without reports of adverse outcomes. Specific aims of the current study include: 1) To obtain a more in-depth understanding of configurations of psychosocial and situational factors associated with high-risk sexual behavior, substance use, STI/HIV and contraceptive use among abused minority adolescent women with STI; 2) To implement a controlled randomized trial of a cognitive behavioral risk-reduction intervention consisting of 2 small group sessions, 2 individual counseling and 3 support groups for this group; 3) To evaluate the effects of the adolescent intervention model versus enhanced counseling for this group on AIDS Risk Reduction Model (ARRM)-related constructs, high-risk sexual behavior, substance use, abuse recurrence, contraceptive use, unintended pregnancy and STI/HIV at 6 and 12 months follow-up. Participants will include a convenience sample of 600 Mexican-and African American adolescent women, aged 14-18 years with a history of sexual or physical abuse and current STI.
Primary Outcome
Infection at 12 months with either chlamydia or gonorrhea
Interventions
- BEHAVIORAL Project IMAGE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2004-10 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT01387646 record still lists
NCT01387646 is an interventional study that assigns participants to a tested intervention. The registered 562 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (323% higher).
The record links to 0 conditions, and to 1 intervention - of which Project IMAGE is the first listed.
NCT01387646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01387646 about?
NCT01387646 is a clinical study titled "Behavioral Intervention for Minority Adolescent Women". The purpose of this Stage II clinical trial is to test the efficacy of a culturally sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy and abuse by changing high-risk ...
What is the current status of trial NCT01387646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 562 participants. The study started on 2004-10. Estimated completion is 2009-04.
What interventions are being tested in trial NCT01387646?
The interventions under investigation include: Project IMAGE (BEHAVIORAL).
Who is sponsoring clinical trial NCT01387646?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01387646's enrollment target sits among peer trials
562 60th of 2000 higher than 1,941 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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