NCT00748800

Brief Summary

Adolescents are at risk for HIV because of sexual and drug behavior initiated during this developmental period. Adolescents in the juvenile justice system are at increased risk for HIV due to higher rates of substance use and psychopathology than their non-offending peers. Juvenile justice youth may therefore also be less likely to benefit from frequently used skills based interventions. It appears that emotional lability, frequently found in this population, disrupts skills learned. This project will implement and evaluate an affect management HIV prevention intervention for adolescents in a juvenile drug court program. Affect management and general health promotion interventions will be compared to determine which intervention best reduces risk behavior among adolescents in the drug court.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Sep 2004

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

2.7 years

First QC Date

September 5, 2008

Last Update Submit

February 5, 2009

Conditions

Keywords

HIV preventionHIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • Adolescent-reported sexual activity and condom use

    3 month post-intervention

Secondary Outcomes (1)

  • Adolescent substance use (self-report and urine toxicology screen results)

    3 months post-intervention

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Affect Management

2

ACTIVE COMPARATOR
Behavioral: General Health Promotion

Interventions

5 session group intervention that focused on teaching affect management skills and included HIV prevention and sexual health training

1

5 session group focused on delivering general health promotion information in didactic format

2

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents enrolled in the juvenile drug court program

You may not qualify if:

  • Adolescent is HIV positive
  • Adolescent is pregnant
  • Adolescent is developmentally delayed
  • Adolescent has history of sexual crime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Larry K Brown, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 9, 2008

Study Start

September 1, 2004

Primary Completion

May 1, 2007

Study Completion

October 1, 2007

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations