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HIV, Abuse, and Psychiatric Disorders Among Youth (Project STAR)

This study has been completed.
Sponsor:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00603369
First received: January 16, 2008
Last updated: February 5, 2009
Last verified: February 2009
History of Changes
  Purpose

One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders. Furthermore, those with histories of sexual abuse have been found to have riskier attitudes, poorer sexual communication skills, and less consistent condom use than non-abused peers. This study implemented and evaluated interventions for adolescents in intensive psychiatric treatment settings, particularly those with histories of sexual abuse. It is hypothesized that those participating in the intervention that addresses affect management and cognitive monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest than peers in an information-based intervention.


Condition Intervention Phase
HIV Infections
 Behavioral: group intervention
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV, Abuse, and Psychiatric Disorders Among Youth

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • condom use [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • scores on HIV knowledge questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • number of sexual partners [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • scores on measure of attitudes toward condom use [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: September 1999
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
13 session group intervention including sexual health information, affect management skills, cognitive monitoring, and communication skills training.
 Behavioral: group intervention
13-session intervention
Active Comparator: 2
2 session group intervention including sexual health information training.
 Behavioral: group intervention
2-session intervention

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescent attending therapeutic school

Exclusion Criteria:

  • Adolescent is HIV positive
  • Adolescent is developmentally delayed
  • Adolescent is pregnant
  • Adolescent has a history of sexual crime
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603369

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Larry K. Brown, MD Rhode Island Hospital
  More Information

No publications provided by Rhode Island Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Larry K. Brown/Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00603369     History of Changes
Other Study ID Numbers: R01 MH061149, R01 MH061149
Study First Received: January 16, 2008
Last Updated: February 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV prevention
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Mental Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013