Partner-Specific HIV Risk Reduction Intervention for Drug-Using Adolescents (GET UP)

December 3, 2012 updated by: Cynthia Rosengard, Women and Infants Hospital of Rhode Island

Partner-Specific HIV Risk Reduction Intervention for Drug-Using Incarcerated Adolescents

The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Incarcerated adolescents represent a group at high risk for health consequences associated with risky sexual behaviors. Condom use is more common with non-main than main sex partners and substance use in conjunction with sexual risk also appears to vary by partner type. The research team will conduct a small randomized trial to pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use. Participants will be randomized to a 5 session HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model, or a 5 session healthy lifestyles psychoeducation intervention, and then reassessed 3 months after their access to the general community is reinstated. The main hypothesis is that participants in the HIV risk reduction intervention condition will have lower levels of sex-related HIV risk behavior and of substance use in conjunction with sexual risk, relative to those in a healthy lifestyles psychoeducation intervention.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English-speaking ability
  • unprotected vaginal, anal, or oral intercourse at least once in the 6 months prior to incarceration or placement
  • marijuana use disorders, other non-injection drug use disorders, or substance use by a sexual partner during a sexual episode in the six months prior to incarceration or placement
  • sentence or placement length between 2 and 12 months
  • must plan to remain in the area for the 6 months following their release from the facility
  • must be willing to provide two pieces of contact information for follow-up

Exclusion Criteria:

  • signs of psychosis (assessed through clinical assessment)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Partner Specific IMB
partner-specific HIV risk reduction intervention
Behavioral: Partner-Specific IMB-based HIV risk reduction intervention
5 session partner-specific HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model.
Placebo Comparator: HLS
5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills.
Behavioral: Healthy Lifestyle
5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lower levels of sex-related HIV risk behavior
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
knowledge about STI transmission
Time Frame: 3 months
3 months
partner-specific perceptions of STI risks
Time Frame: 3 months
3 months
social norms, expectations and personal attitudes regarding partner-specific sexual behavior
Time Frame: 3 months
3 months
partner-specific behavioral and communication skills
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Collaborators

University of Rhode Island

Investigators

  • Principal Investigator: Cynthia Rosengard, PhD, MPH, Women & Infants of Rhode Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimate)

January 29, 2009

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0128
  • R01DA022921-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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