HIV Prevention for Youth With Severe Mental Illness
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Family-based HIV prevention program
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV prevention, HIV Seronegativity
Eligibility Criteria
Inclusion Criteria:
- Adolescent in mental health treatment
- Living with parent/caregiver past 3 months
Exclusion Criteria:
- Adolescent is HIV positive
- Adolescent is pregnant
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Parent-child
Adolescent only intervention focusing on condom use skills and assertiveness training around sexual discussions
Health promotion intervention including general health promotion topics such as smoking, diet, exercise, etc.
Outcomes
Primary Outcome Measures
condom use; sexual delay
Secondary Outcome Measures
parent-adolescent sexual communication
condom use attitudes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00496691
Brief Title
HIV Prevention for Youth With Severe Mental Illness
Official Title
HIV Prevention for Youth With Severe Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV prevention, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
718 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Parent-child
Arm Title
2
Arm Type
Active Comparator
Arm Description
Adolescent only intervention focusing on condom use skills and assertiveness training around sexual discussions
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Health promotion intervention including general health promotion topics such as smoking, diet, exercise, etc.
Intervention Type
Behavioral
Intervention Name(s)
Family-based HIV prevention program
Intervention Description
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
Primary Outcome Measure Information:
Title
condom use; sexual delay
Time Frame
3 years
Secondary Outcome Measure Information:
Title
parent-adolescent sexual communication
Time Frame
3 years
Title
condom use attitudes
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adolescent in mental health treatment
Living with parent/caregiver past 3 months
Exclusion Criteria:
Adolescent is HIV positive
Adolescent is pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry K Brown, MD
Organizational Affiliation
Rhode Island Hospital/ Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24382603
Citation
Brown LK, Hadley W, Donenberg GR, DiClemente RJ, Lescano C, Lang DM, Crosby R, Barker D, Oster D. Project STYLE: a multisite RCT for HIV prevention among youths in mental health treatment. Psychiatr Serv. 2014 Mar 1;65(3):338-44. doi: 10.1176/appi.ps.201300095.
Results Reference
derived
Learn more about this trial
HIV Prevention for Youth With Severe Mental Illness
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