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NCT00496691 · ClinicalTrials.gov registry record · Phase 1
HIV Prevention for Youth With Severe Mental Illness
A Phase 1 study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 718
- Enrollment target
NCT00496691 is a Phase 1 study that has completed, run by Rhode Island Hospital. The registered enrollment target is 718 participants.
The verdict
NCT00496691, a Phase 1 study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 718 participants
- Enrollment target
Study Summary
This 4-year competing continuation will extend the follow-up for 750 subjects enrolled in a randomized interventions trial, Project STYLE: "HIV Prevention for Youth with Severe Mental Illness" (R01, MH 63008). Extending the follow-up from one year to 36 months will 1) discern the long-term impact of the Project STYLE interventions and 2) permit complex modeling of the predictors and trajectories of sexual health (delay of sex) and risk (incident STIs). Adolescents, particularly those in mental health treatment, are at risk for HIV because of sexual and substance behaviors. Parent-child communication about sexual topics and parental supervision are associated with delays in the onset of sexual activity and more responsible sexual behavior; thus, the parent project, Project STYLE, is a randomized trial that is evaluating the comparative efficacy of three interventions: a) family-based HIV prevention intervention, b) adolescent-only HIV prevention intervention, and c) general health promotion intervention. This multi-site project (Rhode Island Hospital, Emory University, and the University of Illinois at Chicago) is enrolling an ethnically/racially/geographically diverse group of 750 adolescents in outpatient mental health treatment and their parents. Subjects receive a full day group intervention on the day of randomization, return in two weeks for an individual session, participate in a half day booster session three months later, and are assessed six and 12 months after the intervention. This application offers a unique opportunity to assess this already ascertained sample at three additional points (24,30, and 36 months). This is important because few studies have examined the longer-term predictors of the delay of sex and incident STIs over 36 months using a comprehensive array of family functioning, family monitoring/communication, and trauma history. Additionally, this continuation will provide important data concerning the long-term impact of Project STYLE's th
Interventions
- BEHAVIORAL Family-based HIV prevention program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 718 participants |
| Start Date | 2002-04 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00496691
The ClinicalTrials.gov registry entry for NCT00496691 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 718 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Family-based HIV prevention program is the first listed.
NCT00496691 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00496691 about?
NCT00496691 is a clinical study titled "HIV Prevention for Youth With Severe Mental Illness". This 4-year competing continuation will extend the follow-up for 750 subjects enrolled in a randomized interventions trial, Project STYLE: "HIV Prevention for Youth with Severe Mental Illness" (R01, MH 63008). Extending the follow-up from one year to 36 months will 1) discern the long-term impact of...
What is the current status of trial NCT00496691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 718 participants. The study started on 2002-04. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00496691?
The interventions under investigation include: Family-based HIV prevention program (BEHAVIORAL).
Who is sponsoring clinical trial NCT00496691?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
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