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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 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.
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.
Interventions
- BEHAVIORAL Project IMAGE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2004-10 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01387646
The ClinicalTrials.gov registry entry for NCT01387646 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 562 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Project IMAGE is the first listed.
NCT01387646 reports 0 study locations.
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.
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