Effectiveness of Structured Ecosystems Therapy for Reducing HIV Risk Behaviors and Improving Treatment Adherence in HIV Infected Men Released From Prison

HIV Infections Clinical Trial

Official title:

Ecosystems Therapy for Men Reintegrating Into Their Family

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344591
• Other study ID #: R01MH067495
• Secondary ID: R01MH067495DAHBR
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2006
• Last updated: July 22, 2015
• Start date: January 2005

Study information

• Verified date: July 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of Structured Ecosystems Therapy (SET), a form of therapy that includes family and caregivers, at reducing HIV transmission risk behaviors and improving treatment adherence in HIV infected men newly released from prison.

Description:

Individuals in prison are four times more likely to have HIV or AIDS as compared to non-incarcerated people. Once HIV infected individuals are released from prison, they have a high risk of transmitting HIV to their sexual or needle-sharing partners. Therefore, it is important to encourage HIV risk reduction behavior among such inmates who are nearing release from prison. SET is a therapy program that mobilizes family and caregivers as a way to support and encourage behavior change within an individual. This study will use a tailored SET program to meet the specific needs of prisoners who are infected with HIV. The purpose of the study is to compare the effectiveness of the tailored SET program versus an individually focused therapy program at reducing sexual and drug-related HIV transmission risk factors and increasing HIV treatment adherence in HIV infected men who have recently been released from prison.

This 12-month study will enroll HIV infected men who are being released from the California Medical Facility Prison in Vacaville, California or the San Quentin State Prison in Marin County, California. Participants will meet with study recruiters while in prison and complete questionnaires to assess sexual and drug-related HIV transmission risk behaviors and treatment adherence; they will also participate in a health education session. Participants will then be randomly assigned to either a 4-month tailored SET program or a 4-month individually focused therapy program. All participants will meet with study counselors twice while still in prison, and then weekly during the first 4 months following release from prison. Participants in the SET program will work with study counselors to tailor the program to meet their individual needs. Therapy sessions will be designed to restructure interactions and communication patterns between the participant and his support network; main goals will include reducing sexual and drug-related risk behaviors and improving HIV treatment adherence. Participants in the individually focused therapy program will focus on harm reduction, goal setting, and motivational enhancement. HIV transmission risk behaviors and treatment adherence will be assessed with surveys administered at Months 4, 8, and 12 for all participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV infected

• Scheduled to be released from the California Medical Facility Prison in Vacaville, California or from San Quentin State Prison in Marin County, California between 21 to 90 days following study entry

• Speaks English or Spanish

• Able to provide contact information for at least one adult who will be living in the area and is able to participate in the study

Exclusion Criteria:

• Participation in the pilot study or previous enrollment in the study

• Release into another correctional facility or other restricted environment (after the initial release from prison) that would prevent participation in the study for more than 2 weeks (e.g., drug treatment program that does not allow visitors)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• Structured Ecosystems Therapy (SET)

• Individually tailored intervention

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV transmission risk behaviors		12 months	No
Primary	HIV-related medical adherence		12 months	No
Secondary	Mediators of HIV transmission risk reduction and medical adherence		12 months	No
Secondary	Recidivism to prison		12 months	No