HIV Prevention for Youth With Severe Mental Illness

NCT00496691 | Completed Phase 1 DMC

• 2 other identifiers: R01-MH63008-5R01MH063008
• Study Type: interventional
• Target: 718
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV prevention; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• condom use; sexual delay

  3 years

Secondary Outcomes (2)

• parent-adolescent sexual communication

  3 years

• condom use attitudes

  3 years

Study Arms (3)

1

EXPERIMENTAL

Parent-child

Behavioral: Family-based HIV prevention program

2

ACTIVE COMPARATOR

Adolescent only intervention focusing on condom use skills and assertiveness training around sexual discussions

Behavioral: Family-based HIV prevention program

3

PLACEBO COMPARATOR

Health promotion intervention including general health promotion topics such as smoking, diet, exercise, etc.

Behavioral: Family-based HIV prevention program

Interventions

Family-based HIV prevention program BEHAVIORAL

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

1; 2; 3

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Adolescent is HIV positive
• Adolescent is pregnant

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• 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.

  PMID: 24382603 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Larry K Brown, MD

  Rhode Island Hospital/ Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: April 1, 2002
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 20, 2016

Record last verified: 2015-01

Locations

US (1)