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Alcohol Use and Sexual Risk: An Intervention

Primary Purpose

Sexual Risk Behavior, Alcohol Use, Drug Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Information only
Sexual risk reduction intervention
sexual risk reduction + alcohol risk reduction component
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Risk Behavior focused on measuring sexual risk behavior among adolescents, alcohol and drug use among adolescents

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Age less than 14 or non-English speaking

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Information only

sexual risk reduction intervention

SRRI+ETOH

Arm Description

Outcomes

Primary Outcome Measures

Condom use

Secondary Outcome Measures

alcohol use

Full Information

First Posted
June 3, 2009
Last Updated
June 4, 2009
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT00914719
Brief Title
Alcohol Use and Sexual Risk: An Intervention
Official Title
Alcohol Use and Sexual Risk: An Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of New Mexico

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Risk Behavior, Alcohol Use, Drug Use
Keywords
sexual risk behavior among adolescents, alcohol and drug use among adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Enrollment
484 (false)

8. Arms, Groups, and Interventions

Arm Title
Information only
Arm Type
Active Comparator
Arm Title
sexual risk reduction intervention
Arm Type
Active Comparator
Arm Title
SRRI+ETOH
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Information only
Intervention Type
Behavioral
Intervention Name(s)
Sexual risk reduction intervention
Intervention Type
Behavioral
Intervention Name(s)
sexual risk reduction + alcohol risk reduction component
Primary Outcome Measure Information:
Title
Condom use
Time Frame
one year
Secondary Outcome Measure Information:
Title
alcohol use
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All young people between the ages of 14 and 17 who were in the detention centers at which recruitment took place. Exclusion Criteria: Age less than 14 or non-English speaking
Facility Information:
Facility Name
University of Colorado
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16917669
Citation
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.
Results Reference
background
PubMed Identifier
19170452
Citation
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.
Results Reference
result
PubMed Identifier
19901006
Citation
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.
Results Reference
derived

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Alcohol Use and Sexual Risk: An Intervention

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