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

Tracking Information
First Submitted Date ICMJE	January 28, 2009
First Posted Date ICMJE	January 29, 2009
Last Update Posted Date	December 5, 2012
Study Start Date ICMJE	February 2009
Actual Primary Completion Date	January 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 8, 2010)	lower levels of sex-related HIV risk behavior [ Time Frame: 3 months ]
Original Primary Outcome Measures ICMJE; (submitted: January 28, 2009)	lower levels of sex-related HIV risk behavior [ Time Frame: 3 months & 6 months ]
Change History	Complete list of historical versions of study NCT00831883 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 8, 2010)	knowledge about STI transmission [ Time Frame: 3 months ]; partner-specific perceptions of STI risks [ Time Frame: 3 months ]; social norms, expectations and personal attitudes regarding partner-specific sexual behavior [ Time Frame: 3 months ]; partner-specific behavioral and communication skills [ Time Frame: 3 months ]
Original Secondary Outcome Measures ICMJE; (submitted: January 28, 2009)	knowledge about STI transmission [ Time Frame: 3 months & 6 months ]; partner-specific perceptions of STI risks [ Time Frame: 3 months & 6 months ]; social norms, expectations and personal attitudes regarding partner-specific sexual behavior [ Time Frame: 3 months & 6 months ]; partner-specific behavioral and communication skills [ Time Frame: 3 months & 6 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Partner-Specific HIV Risk Reduction Intervention for Drug-Using Adolescents
Official Title ICMJE	Partner-Specific HIV Risk Reduction Intervention for Drug-Using Incarcerated Adolescents
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Sexually Transmitted Diseases; Substance-Related Disorders
Intervention ICMJE	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.; 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.
Study Arms	Experimental: Partner Specific IMB partner-specific HIV risk reduction intervention Intervention: Behavioral: Partner-Specific IMB-based HIV risk reduction intervention; 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. Intervention: Behavioral: Healthy Lifestyle
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 21, 2011)	59
Original Estimated Enrollment ICMJE; (submitted: January 28, 2009)	74
Actual Study Completion Date	January 2011
Actual Primary Completion Date	January 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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)
Sex/Gender	Sexes Eligible for Study: All
Ages	15 Years to 18 Years (Child, Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00831883
Other Study ID Numbers ICMJE	08-0128; R01DA022921-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Cynthia Rosengard, Women and Infants Hospital of Rhode Island
Study Sponsor ICMJE	Women and Infants Hospital of Rhode Island
Collaborators ICMJE	University of Rhode Island
Investigators ICMJE	Principal Investigator: Cynthia Rosengard, PhD, MPH Women & Infants of Rhode Island
PRS Account	Women and Infants Hospital of Rhode Island
Verification Date	December 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP