HIV Prevention for Youth With Severe Mental Illness
NCT00496691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 718
Last updated 2016-05-20
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 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.
Conditions
- HIV Infections
Interventions
- 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
Sponsors & Collaborators
-
Rhode Island Hospital
lead OTHER
Principal Investigators
-
Larry K Brown, MD · Rhode Island Hospital/ Brown University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2002-04-30
- Primary Completion
- 2010-12-31
- Completion
- 2010-12-31
Countries
- United States
Study Locations
More Related Trials
-
Randomized Control Trial of Family-Based HIV Prevention for Latinos
NCT01635335 ·Status: COMPLETED ·Phase: PHASE2
-
Digital Star: HIV Prevention for Youth in Mental Health Treatment
NCT02921841 ·Status: COMPLETED ·Phase: NA
-
Engaging Seronegative Youth to Optimize HIV Prevention Continuum
NCT03134833 ·Status: COMPLETED ·Phase: NA
-
HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment
NCT01383837 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
HIV Prevention With the Mentally Ill
NCT00643305 ·Status: COMPLETED ·Phase: PHASE2
-
Affect Management for Early Adolescents
NCT01197404 ·Status: COMPLETED ·Phase: PHASE2
-
Peer Mentors for Adolescents in HIV Affected Families
NCT00056953 ·Status: COMPLETED ·Phase: PHASE2
-
Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
NCT01741311 ·Status: COMPLETED ·Phase: NA
-
HIV Prevention Intervention for People Living With HIV/AIDS
NCT01061021 ·Status: COMPLETED ·Phase: PHASE2
-
Long-Term Survival With HIV: Psychological and Behavioral Factors Associated With the Transition From Adolescence to Young Adulthood
NCT00026806 ·Status: COMPLETED
-
Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings
NCT01264185 ·Status: COMPLETED
-
HIV/AIDS, Severe Mental Illness and Homelessness
NCT01172704 ·Status: COMPLETED ·Phase: PHASE2
-
Intervention Development for Newly Diagnosed Youth With HIV
NCT00255892 ·Status: COMPLETED
-
Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection
NCT03205696 ·Status: COMPLETED
-
Improving Treatment Adherence in HIV-Infected Individuals
NCT00247611 ·Status: COMPLETED ·Phase: PHASE2
-
Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments
NCT05110963 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
NCT02579135 ·Status: COMPLETED ·Phase: NA
-
Stress-Reducing Interventions in HIV+ Patients: Pilot
NCT00599599 ·Status: UNKNOWN ·Phase: NA
-
A Trauma-Informed Intervention for the Newly HIV-Diagnosed
NCT07055360 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Training Community Members to Deliver HIV Prevention Programs to Urban Youth
NCT00859144 ·Status: COMPLETED ·Phase: PHASE3
-
Family-based HIV Prevention for Adolescent Girls
NCT00243126 ·Status: COMPLETED ·Phase: NA
-
Support To Reunite Involve and Value Each Other
NCT00996541 ·Status: COMPLETED ·Phase: NA
-
Family-Based HIV Prevention for Latinos
NCT00582101 ·Status: COMPLETED ·Phase: PHASE1
-
Determining Characteristics and Behaviors of Adolescent Women Regarding HIV Risk and Microbicide Trial Participation
NCT00872261 ·Status: COMPLETED
-
Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men
NCT00231972 ·Status: COMPLETED ·Phase: NA