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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00344591 |
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.
Condition | Intervention | Phase |
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HIV Infections Acquired Immunodeficiency Syndrome |
Behavioral: Structured Ecosystems Therapy (SET) |
Phase II |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Ecosystems Therapy for Men Reintegrating Into Their Family |
Estimated Enrollment: | 200 |
Study Start Date: | January 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Olga Grinstead, PhD, MPH | 415-597-9168 | ogrinstead@psg.ucsf.edu |
Contact: Kathleen McCartney | 415-597-9279 | kmccartney@psg.ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94105 | |
Contact: Kathleen McCartney 415-597-9279 kmccartney@psg.ucsf.edu |
Principal Investigator: | Olga Grinstead, PhD, MPH | University of California, San Francisco |
Study ID Numbers: | R01 MH67495, DAHBR 9A-ASI |
Study First Received: | June 23, 2006 |
Last Updated: | June 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00344591 History of Changes |
Health Authority: | United States: Federal Government |
HIV AIDS |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Disease Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Virus Diseases Pathologic Processes HIV Infections Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |