NCT00914719

Brief Summary

Adolescents are at great risk for sexually transmitted diseases (STDs) including the human immunodeficiency virus (HIV) (CDC, 2000a; DiLorenzo \& Whaley, 1999). Though the CDC (2000b) reports that overall AIDS incidence is on the decline, there has been no comparable decline in the number of newly diagnosed HIV cases among young people aged 13-19, and young people of color are particularly at risk. Compared to the general adolescent population, adolescents involved with the criminal justice system are younger at first intercourse, have a greater number of sex partners, and lower rates of condom use, resulting in higher rates of unintended pregnancy and STDs (e.g., St. Lawrence et al., 1999). Alcohol use is commonly cited as a reason for lack of condom use among high-risk adolescents such as those involved in the criminal justice system (e.g., Morris et al., 1998) and recent data from our research suggests that it is heavy alcohol use in concert with sexual activity that is most strongly related to lack of condom use (Bryan, Rocheleau, \& Robbins, 2002a). The goal of this research is to design, implement, evaluation, and disseminate a successful HIV/STD risk reduction intervention that is theory-based, empirically targeted to adolescents, and articulated to a criminal justice setting. The study compares a sexual risk reduction intervention with a group motivational interviewing alcohol component to a standard sexual risk reduction intervention and a no treatment control condition. The investigators hope to show that: 1) A three-hour one-time intervention has the capacity to reduce sexual risk behavior up to one year post-release among high risk adolescents in detention, 2) A combined sexual and alcohol risk reduction intervention will result in larger decreases in sexual risk behavior than a sexual risk reduction alone, 3) The interventions will exert their effects through changes in mediators derived from a theoretically-based model of condom use intentions and behaviors, and 4) A sexual risk reduction intervention including an alcohol component will be especially effective for those adolescents with higher levels of existing alcohol problems. Finally, given proven efficacy, the intervention curricula and materials will be disseminated for use in adolescent detention facilities throughout the state.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2002

Geographic Reach
1 country

1 active site

Status
withdrawn

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, 2002

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

Same day

First QC Date

June 3, 2009

Last Update Submit

January 9, 2024

Conditions

Keywords

sexual risk behavior among adolescentsalcohol and drug use among adolescents

Outcome Measures

Primary Outcomes (1)

  • Condom use

    one year

Secondary Outcomes (1)

  • alcohol use

    one year

Study Arms (3)

Information only

ACTIVE COMPARATOR
Behavioral: Information only

sexual risk reduction intervention

ACTIVE COMPARATOR
Behavioral: Sexual risk reduction intervention

SRRI+ETOH

EXPERIMENTAL
Behavioral: sexual risk reduction + alcohol risk reduction component

Interventions

Information only
sexual risk reduction intervention

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All young people between the ages of 14 and 17 who were in the detention centers at which recruitment took place.

You may not qualify if:

  • Age less than 14 or non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Boulder, Colorado, 80309, United States

Location

Related Publications (3)

  • Bryan A, Schmiege SJ, Broaddus MR. Mediational analysis in HIV/AIDS research: estimating multivariate path analytic models in a structural equation modeling framework. AIDS Behav. 2007 May;11(3):365-83. doi: 10.1007/s10461-006-9150-2.

    PMID: 16917669BACKGROUND
  • Schmiege SJ, Broaddus MR, Levin M, Bryan AD. Randomized trial of group interventions to reduce HIV/STD risk and change theoretical mediators among detained adolescents. J Consult Clin Psychol. 2009 Feb;77(1):38-50. doi: 10.1037/a0014513.

  • Bryan AD, Schmiege SJ, Broaddus MR. HIV risk reduction among detained adolescents: a randomized, controlled trial. Pediatrics. 2009 Dec;124(6):e1180-8. doi: 10.1542/peds.2009-0679. Epub 2009 Nov 9.

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 5, 2009

Study Start

September 1, 2002

Primary Completion

September 1, 2002

Study Completion

September 1, 2002

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations