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

Primary Purpose

Sexually Transmitted Diseases, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Partner-Specific IMB-based HIV risk reduction intervention
Healthy Lifestyle
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Adolescent, Adolescent behavior, Health behavior, Sexual Behavior, Incarceration, Behavioral Intervention, Risk Reduction Behavior

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Women & Infants Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Partner Specific IMB

HLS

Arm Description

partner-specific HIV risk reduction intervention

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.

Outcomes

Primary Outcome Measures

lower levels of sex-related HIV risk behavior

Secondary Outcome Measures

knowledge about STI transmission
partner-specific perceptions of STI risks
social norms, expectations and personal attitudes regarding partner-specific sexual behavior
partner-specific behavioral and communication skills

Full Information

First Posted
January 28, 2009
Last Updated
December 3, 2012
Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
University of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT00831883
Brief Title
Partner-Specific HIV Risk Reduction Intervention for Drug-Using Adolescents
Acronym
GET UP
Official Title
Partner-Specific HIV Risk Reduction Intervention for Drug-Using Incarcerated Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
University of Rhode Island

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, Substance-Related Disorders
Keywords
Adolescent, Adolescent behavior, Health behavior, Sexual Behavior, Incarceration, Behavioral Intervention, Risk Reduction Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partner Specific IMB
Arm Type
Experimental
Arm Description
partner-specific HIV risk reduction intervention
Arm Title
HLS
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Partner-Specific IMB-based HIV risk reduction intervention
Intervention Description
5 session partner-specific HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyle
Intervention Description
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.
Primary Outcome Measure Information:
Title
lower levels of sex-related HIV risk behavior
Time Frame
3 months
Secondary Outcome Measure Information:
Title
knowledge about STI transmission
Time Frame
3 months
Title
partner-specific perceptions of STI risks
Time Frame
3 months
Title
social norms, expectations and personal attitudes regarding partner-specific sexual behavior
Time Frame
3 months
Title
partner-specific behavioral and communication skills
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Rosengard, PhD, MPH
Organizational Affiliation
Women & Infants of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

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

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