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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Rhode Island
Information provided by:
Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00831883
First received: January 28, 2009
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Sexually Transmitted Diseases
Substance-Related Disorders
 Behavioral: Partner-Specific IMB-based HIV risk reduction intervention
Behavioral: Healthy Lifestyle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Partner-Specific HIV Risk Reduction Intervention for Drug-Using Incarcerated Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • lower levels of sex-related HIV risk behavior [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • knowledge about STI transmission [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • partner-specific perceptions of STI risks [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • social norms, expectations and personal attitudes regarding partner-specific sexual behavior [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • partner-specific behavioral and communication skills [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: February 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831883

Locations
United States, Rhode Island
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
University of Rhode Island
Investigators
Principal Investigator: Cynthia Rosengard, PhD, MPH Women & Infants of Rhode Island
  More Information

No publications provided

Responsible Party: Cynthia Rosengard, PhD, MPH - Associate Professor of Obstetrics & Gynecology and Medicine (Research), Women & Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00831883     History of Changes
Other Study ID Numbers: 08-0128, R01 DA022921-03
Study First Received: January 28, 2009
Last Updated: January 21, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Women and Infants Hospital of Rhode Island:
Adolescent
Adolescent behavior
Health behavior
Sexual Behavior
 Incarceration
Behavioral Intervention
Risk Reduction Behavior

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Substance-Related Disorders
Infection
Virus Diseases
 Genital Diseases, Male
Genital Diseases, Female
Mental Disorders

ClinicalTrials.gov processed this record on October 18, 2012