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 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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Family-based HIV prevention program

• Study Type: Interventional
• Enrollment (Actual): 718
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adolescent in mental health treatment
• Living with parent/caregiver past 3 months

Exclusion Criteria:

• Adolescent is HIV positive
• Adolescent is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
condom use; sexual delay	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
parent-adolescent sexual communication	3 years
condom use attitudes	3 years

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Investigators: Principal Investigator: Larry K Brown, MD, Rhode Island Hospital/ Brown University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 3, 2007
• First Submitted That Met QC Criteria: July 3, 2007
• First Posted (Estimate): July 4, 2007

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV prevention
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: R01-MH63008-5; R01MH063008 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No