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

Ecosystems Therapy for Men Reintegrating Into Their Family

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00344591
Enrollment
162
Registered
2006-06-27
Start date
2005-01-31
Completion date
Unknown
Last updated
2015-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Immunodeficiency Syndrome, HIV Infections

Keywords

HIV, AIDS

Brief 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.

Detailed 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.

Interventions

BEHAVIORALStructured Ecosystems Therapy (SET)
BEHAVIORALIndividually tailored intervention

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
HIV transmission risk behaviors12 months
HIV-related medical adherence12 months

Secondary

MeasureTime frame
Mediators of HIV transmission risk reduction and medical adherence12 months
Recidivism to prison12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026