HIV Prevention for Youth With Severe Mental Illness

Lifespan

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Behavioral: Family-based HIV prevention program

Study type: Interventional

Funder types: Other

Identifiers

NCT00496691

R01-MH63008-5

R01MH063008 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 718 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Adolescent is HIV positive
• Adolescent is pregnant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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718 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Parent-child

Treatment:

Behavioral: Family-based HIV prevention program

2

Active Comparator group

Description:

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

Treatment:

Behavioral: Family-based HIV prevention program

3

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Family-based HIV prevention program