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

Substance-Related Disorders Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831883
• Other study ID #: 08-0128
• Secondary ID: R01DA022921-03
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: December 3, 2012
• Start date: February 2009
• Est. completion date: January 2011

Study information

• Verified date: December 2012
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Substance-Related Disorders

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.
• 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.

Locations

Country	Name	City	State
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lower levels of sex-related HIV risk behavior		3 months	No
Secondary	knowledge about STI transmission		3 months	No
Secondary	partner-specific perceptions of STI risks		3 months	No
Secondary	social norms, expectations and personal attitudes regarding partner-specific sexual behavior		3 months	No
Secondary	partner-specific behavioral and communication skills		3 months	No