HIV Infections Clinical Trial
Official title:
Ecosystems Therapy for Men Reintegrating Into Their Family
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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