HIV Prevention for Youth With Severe Mental Illness
Recruitment status was Active, not recruiting
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Purpose
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 theoretically based HIV prevention programs which are designed to maintain safe sexual behaviors. The Family-Based program has increased parent/adolescent sexual communication and reduced adolescent unprotected sex after six months and extended assessment will determine whether these benefits are maintained over time.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Family-based HIV prevention program |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | HIV Prevention for Youth With Severe Mental Illness |
- condom use; sexual delay [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- parent-adolescent sexual communication [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- condom use attitudes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 718 |
| Study Start Date: | April 2002 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Parent-child
|
Behavioral: Family-based HIV prevention program
comparison between parent-child intervention targeting parent-teen sexual communication, condom use skills, and assertiveness training to an adolescent-only intervention that targets similar constructs minus parent-teen sexual communication and a general health promotion intervention
|
|
Active Comparator: 2
Adolescent only intervention focusing on condom use skills and assertiveness training around sexual discussions
|
Behavioral: Family-based HIV prevention program
comparison between parent-child intervention targeting parent-teen sexual communication, condom use skills, and assertiveness training to an adolescent-only intervention that targets similar constructs minus parent-teen sexual communication and a general health promotion intervention
|
|
Placebo Comparator: 3
Health promotion intervention including general health promotion topics such as smoking, diet, exercise, etc.
|
Behavioral: Family-based HIV prevention program
comparison between parent-child intervention targeting parent-teen sexual communication, condom use skills, and assertiveness training to an adolescent-only intervention that targets similar constructs minus parent-teen sexual communication and a general health promotion intervention
|
Eligibility| Ages Eligible for Study: | 13 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Adolescent in mental health treatment
- Living with parent/caregiver past 3 months
Exclusion Criteria:
- Adolescent is HIV positive
- Adolescent is pregnant
Contacts and Locations| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Principal Investigator: | Larry K Brown, MD | Rhode Island Hospital/ Brown University |
More Information
No publications provided
| Responsible Party: | Larry K. Brown/Principal Investigator, Rhode Island Hospital |
| ClinicalTrials.gov Identifier: | NCT00496691 History of Changes |
| Other Study ID Numbers: | R01-MH63008-5 |
| Study First Received: | July 3, 2007 |
| Last Updated: | February 5, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rhode Island Hospital:
|
HIV prevention HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Mental Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013